Research Article - International Journal of Medical Research & Health Sciences ( 2025) Volume 14, Issue 1
A Clinical Study to Determine the Efficacy of Pramehhara Kwatha in the Management of Madhumeha W.S.R. to Type II Diabetes Mellitus
Anant Bhardwaj*Anant Bhardwaj, Department of Kriya Sharira (Human Physiology), Rajkiya Ayurvedic, Yoga avam Prakritik Mahavidhyalaya, Jaipur, Rajasthan, India, Email: abhimachali@gmail.com
Received: 06-Nov-2023, Manuscript No. IJMRHS-23-119317; Editor assigned: 08-Nov-2023, Pre QC No. IJMRHS-23-119317 (PQ); Reviewed: 22-Nov-2023, QC No. IJMRHS-23-119317; Revised: 13-Jan-2025, Manuscript No. IJMRHS-23-119317 (R); Published: 20-Jan-2025
Abstract
The present is an era of rapid modernization. Due to sedentary lifestyle and faulty dietary habits, humans are becoming more vulnerable to several metabolic disorders. Preameha is one of them which is caused by association of vitiated tridoshas and morbid Meda, Rakta, Shukra, Ambu, Vasa, Lasika, Majja, Rasa, Oja and Mamsa dhatus. In modern science, it resembles the symptomatology of type II diabetes mellitus which is caused by inadequate insulin production, improper insulin action, or both. In 20th century Dr. Gananath Sen and others have expounded about the theory that Madhumeha is Dhatwagni mandya vikara which can be correlated to diabetes mellitus. Type 2 diabetes mellitus may be included under the broad spectrum of prameha described in Ayurvedic classics. Prameha is considered as Mahagada by Ayurvedic Acharayas. Mahagada are diseases having chronicity with involvement of Tridoshas, multiple Dhatus and Strotases affecting vital organs and thus rendering them difficult to treat. From Ayurvedic point of view, Prameha seems to stem from metabolic derangements at different levels caused either due to genetic factor or due to Apathya Ahara and Vihara. The prevalence of diabetes in high socio-economic population of rural areas is more and in rural areas of all states of India, diabetes was more prevalent in individuals of higher SES. In the next 20 years, it is expected that the prevalence of diabetes in adults-of which type 2 DM is becoming more prevalent. A large portion of this rise will take place in developing nations, where the majority of patients are between the ages of 45 and 64. In 2011, 366 million individuals were expected to have DM; by 2030, this number will have increased to 552 million. It is a potential signal for several comorbidities like hypertension, coronary artery disease, renal diseases etc.
Keywords
Madhumeha, Pramehhara, Metformin, Diabetes mellitus
Introduction
The metabolic and endocrine disorders are either increasing across the globe or may have been observed with more focus in recent years. Diabetes mellitus is one of the most commonly encountered endocrine disease in clinical practice [1].
Due to a competitive lifestyle, urbanisation, and industrialization, the current period is marked by stress and strain. Diabetes mellitus is one of the many metabolic illnesses that have increased in prevalence as a result and are currently of major concern. Diabetes mellitus is a clinical syndrome characterized by hyperglycaemia due to absolute or relative deficiency of insulin. Over a period of time, it can damage the blood vessels and nerves as well as many other body systems which consequently cause life threatening complications [2].
In developing nations, diabetes mellitus is increasingly becoming a major public health issue. According to the World Diabetes Federation, there have been worldwide periodic increases in the number of persons with diabetes. India is known as the "Diabetes Capital of the World" since it has the highest percentage of diabetes patients worldwide. According to the first WHO global report on diabetes from 2016, there are 422 million people worldwide who have diabetes, nearly quadrupling since 1980. Diabetes is expected to overtake heart disease as the seventh biggest cause of death by 2030. Yet, the disease related consequences, which raise morbidity and death, actually burden the population. According to these calculations, diabetes was a significant contributor to heart disease and stroke [3,4].
Diabetes mellitus has gained gigantic disgrace in recent times as it is rapidly becoming world’s largest silent killer. WHO has projected India, as the country with fastest growing population of diabetic patients hence called it the ‘diabetes capital’ of the world. According to recent study by Union Ministry of Family and Health Welfare (MoFHW) published on 6th January 2021, among Indians over 45 years of age 11.5% were diagnosed with diabetes. The prevalence was higher in senior citizens (14%) than in those who aged 45-59 years that is 11.5%. Therefore, the prevalence of diabetes mellitus is increasing and placing burden on health care resources [5].
So, a better, safer, and long-lasting therapy is needed for the present scenario and now it is a demand of time to search the management for this type of ailment through the heritage of Ayurveda. Thus, here an attempt is made to treat Madhumeha W.S.R. to type II diabetes mellitus with herbal medicines after compiling all available references from classical authentic texts [6].
A very scientific and elaborated description of diabetes is available in Ayurvedic literature as Prameha. Ayurvedic classics have laid importance upon the etiological factors, their role in vitiations of Doshas and Dushayas which manifest disease conditions. Besides this, Prameha Roga is also considered due to Beeja Dushti (genetic) or Sahaj (congenital) and also Santarpanoth (due to overeating and sedentary life style). For the purpose of clinical management, patients of Prameha have been divided into two categories that is, Sthula (obese patients) and Krisha (emaciated patients). Ayurveda through its armamentarium can become a potential source of better management of diabetes that may be relatively safe, significantly potent without untoward effects and can improve quality of life [7,8].
Aims and Objectives
Primary objective: To evaluate the clinical efficacy of an Ayurvedic formulation Pramehhara Kwatha in the management of Madhumeha W.S.R. to type II diabetes mellitus.
• To evaluate the clinical efficacy of an Ayurvedic formulation Pramehhara Kwatha as an add on therapy to Metformin in the management of Madhumeha W.S.R. to type II diabetes mellitus.
Secondary objective: To assess the clinical safety of Pramehhara Kwatha in management of Madhumeha W.S.R. to type II diabetes mellitus.
• To assess the clinical safety of Pramehhara Kwatha as an add on therapy to metformin in the management of Madhumeha W.S.R. to type II diabetes mellitus [9].
Material and Methods
Selection of the patient
The proposed work was a clinical trial on willing volunteers. Patients fulfilling the diagnostic and inclusion criteria were selected randomly from OPD/IPD of department of Kayachikitsa, R.G.G.P.G. Ayurvedic Hospital, Paprola. A sample of 45 patients-15 patients in each group was assessed in the clinical study [10].
Study design
• Study type-Randomized clinical trial
• Masking-Single blind
• Timing-Prospective
• Number of patients-45 (15 in each group)
• No of groups-3
• Duration of trial-12 weeks
• Follow up visit-After 2 weeks, 4 weeks, 8 weeks and at the completion of trial.
Diagnostic criteria
Selected study subjects were diagnosed on the basis of:
• Fasting plasma glucose ≥ 126 mg/dl
• PPBS (2-hour plasma glucose level) ≥ 200 mg/dl
• HbA1C ≥ 6.5%
Inclusion criteria
• Study subjects of either gender aged between 20-70 yrs.
• Study subjects of type II diabetes mellitus having:
• Fasting plasma glucose-126 mg/dl to 200 mg/dl
• PPBS (2-hour plasma glucose level)-200 to 400 mg per decilitre of blood.
• HbA1C- 6.5-9 %
• Study subjects willing to participate in the trial.
Exclusion criteria
• Study subjects below the age of 20 yrs. and above the age of 70 yrs.
• Study subjects not willing to participate in the trial.
• Study subjects having FBS >200 mg/dl and/or PPBS >400 mg/dl and/or HbA1c >9%.
• Study subjects having major medical illness like cancer, concurrent infection like tuberculosis.
• Study subjects with uncontrolled hypertension.
• Study subjects with established diagnosis of CAD or any other clinically significant cardiovascular disease.
• Renal dysfunction (defined by eGFR <60 ml/min calculated by MDRD Calculator).
• Subjects who have completed participation in any other clinical trial during the past 3 months.
• Any other condition which the investigator thinks may compromise the safety of the subject.
• Subjects with haemoglobin percentage <9 gm% for males and <8% for females.
• Subject of type-1 DM or type-II DM on insulin/OHA’s other than Metformin/any other medications for glycaemic control in the last 3 months.
• Subjects suffering from the complications of diabetes mellitus viz., diabetic neuropathy, diabetic nephropathy, diabetic retinopathy etc. which require an urgent treatment.
• Subjects with concurrent hepatic dysfunction (defined as AST and/or ALT >3 times of the upper normal limit)
• Uncontrolled pulmonary dysfunction requiring inhalational or systemic steroids.
• Pregnant/lactating women.
Subjects on systemic or inhaled steroids, oral contraceptives pills or oestrogen replacement therapy [11,12].
Investigations
• Haematological: Hb%, TLC, DLC, ESR
• Biochemistry: FBS, PPBS, HbA1C
Blood urea, serum creatinine, serum lipid profile, SGOT, SGPT
• Urine: Routine and microscopic.
Grouping of patients
Study was conducted randomly on 45 patients in three groups (15 patients in each group). Group I was administered with Pramehhara Kwatha 50 ml twice a day, group II was administered with tab. Metformin 1000 mg twice a day while Group III was given Pramehhara Kwatha 50 ml twice a day along with tab. Metformin 1000 mg twice a day [13].
Trial drug
• Pramehhara Kwatha
• Dose-50 ml twice a day (50 gm dry coarse powder of Pramehhara Kwatha was dissolved in 800 ml of water. It
was reduced to 100 ml and taken in two equally divided doses i.e., 50 ml BD) [14].
• Route of administration-Oral
Trial drug composition
Trial drug content described in Table 1.
| Sr. no | Ingredients | Botanical name | Family | Parts used | Part |
|---|---|---|---|---|---|
| 1 | Haritaki | Terminalia chebula (Retz.) | Combretaceae | Pericarp | 1 part |
| 2 | Vibhitaki | Erminalia bellerica (Roxb) | Combretaceae | Pericarp | 1 part |
| 3 | Amalaki | Mblica officinalis (Gaertn) | Euphorbiacea | Pericarp | 1 part |
| 4 | Daruhridra | Berberis aristata (DC.) | Berberidaceae | Root | 1 part |
| 5 | Mustak | Cyperus rotundus (Linn.) | Cyperaceae | Rhizome | 1 part |
Table 1. Contents of Pramehhar Kwatha
Criteria of assessment
• Subjective parameters were assessed before and after the treatment as per grade score.
Objective criteria:
Haematological: Hb%, TLC, DLC, ESR
Biochemistry: FBS, PPBS, HbA1C
Blood urea, Serum creatinine, Serum lipid profile, SGOT, SGPT
• Urine: Routine and microscopic
Grading of subjective criteria
Table 2 describe the grading of subjective criteria.
| Prabhuta Mutrata (Polyuria) | Grade |
|---|---|
| 3-5 times per day, rarely at night | 0 |
| 6-8 times per day, 1-2 times per night | 1 |
| 9-11 times per day, 3-4 times per night | 2 |
| >11 times per day, >4 times per night | 3 |
| Avila Mutrata (Turbidity) | |
| Clear | 0 |
| Faintly cloudy or smoky (turbidity barely visible) | 1 |
| Turbidity clearly present | 2 |
| Highly turbid | 3 |
| Pipasa-Adhikya (Increased Thirst) | |
| Feeling of thirst (7-9 times/24 hrs.) and relieved by drinking water | 0 |
| Feeling of moderate thirst (>9-11 times/24 hrs.) and relieved by drinking water | 1 |
| Feeling of excess thirst (>11-13 times/24 hrs.) not relieved by drinking water | 2 |
| Feeling of severe thirst (>13 times/24 hrs.) not relieved by drinking water | 3 |
| Kshuda-Adhikya (Increased Appetite) | |
| As usual/Routine | 0 |
| Slightly Increased (1 meal extra with routine diet) | 1 |
| Moderate Increased (2 meals extra with routine diet) | 2 |
| Markedly Increased (3 meals extra with routine diet) | 3 |
| Karapada Daha (Burning sensation in hand and feet) | |
| No Daha | 0 |
| Karapada Daha found occasionally, mild bearable | 1 |
| Karapada Daha continuous but bearable and not severe | 2 |
| Karapada Daha continuous and severe and unbearable | 3 |
| Swedadhikya (Perspiration) | |
| Sweating after heavy work and fast movement or in hot weather | 0 |
| Profuse sweating after moderate work and movement | 1 |
| Sweating after little work and movement (stepping ladder etc.) | 2 |
| Profuse sweating after little work and movement | 3 |
| Galatalushosha (Dryness of palate and throat) | |
| None | 0 |
| Mild | 1 |
| Moderate | 2 |
| Severe | 3 |
| Madhurasyata (Feeling sweetness in mouth) | |
| None | 0 |
| Mild | 1 |
| Moderate | 2 |
| Severe | 3 |
| Karapadasuptata (Numbness) | |
| No Karapadasuptata | 0 |
| Hasta-Pada-Tala Daha found occasionally, mild bearable | 1 |
| Hasta-Pada-Tala Daha continuous but bearable and not severe | 2 |
| Hasta-Pada-Tala Daha continuous and severe and unbearable | 3 |
| Shithilangata | |
| None | 0 |
| Mild | 1 |
| Moderate | 2 |
| Severe | 3 |
Table 2. Grading of subjective criteria
Grading of urine routine and microscopic
Table 3 describe grading of urine routine and microscopic.
| Urine sugar | Grade |
|---|---|
| Nil | 0 |
| + | 1 |
| ++ | 2 |
| +++ | 3 |
| Pus cells | |
| Nil | 0 |
| 1-2 | 1 |
| 3-4 | 2 |
| 5-6 | 3 |
| Epithelial cells | |
| Nil | 0 |
| 1-2 | 1 |
| 3-4 | 2 |
| 5-6 | 3 |
Table 3. Grading of urine routine and microscopic
Final assessment of results statistical analysis: Data obtained during the trial was tabulated and statistically analysed using Student Paired ‘t’ Test. The results were considered significant or insignificant on the basis of value of ‘p’.
• Insignificant at p>0.05.
• Significant at p<0.05.
• Highly significant at p<0.001.
Results
Among all the registered study subjects the incidence of Madhumeha was highest in age group 51- 60 years (i.e., 45.09%), males (i.e., 50.9%) and Hindus (i.e., 100%). Majority of the study subjects were household workers (i.e., 39.21 %) and maximum were matriculate (i.e., 33.33%) and majority of study subjects i.e., 66.66% were above poverty line and belonged to rural area (i.e., 68.62%).
Based on the constitutional profile maximum study subjects i.e., 68.62% were living with sedentary lifestyle. Appetite (i.e., 58.82 %) and thirst (i.e., 62.74%) was increased in majority of study subjects. Bowel habit was normal and regular in 74.50 % study subjects and frequency of micturition was increased in majority of the study subjects (i.e., 62.74%). Most of the study subjects i.e., 68.62 % were taking mixed diet and majority of the study subjects were non addicted to smoking or alcohol (i.e., 62.74%). The incidence of Madhumeha was more in study subjects with Pitta-Kaphaj Prakriti (i.e., 47.05%) (Table 4). In the present clinical study frequency of signs and symptomatology observed in registered study subjects is as follows:
• Prabhuta Mutrata in 32 study subjects (62.74%).
• Pipasadikya in 32 study subjects (62.74%).
• Karapadasuptata in 31 study subjects (60.78%).
• Kshudhadikya in 30 study subjects (58.82%).
• Shithilangata in 30 study subjects (58.82%).
• Karapada daha in 29 study subjects (56.86%).
• Swedadikya in 28 study subjects (54.90%).
• Galatalusosha in 26 study subjects (50.98%).
• Avila Mutrata in 25 study subjects (49.01%).
• Madhurasyata in 7 study subjects (13.72%).
| Sr. no. | Symptoms | Gr. I | Gr. II | Gr. III | Total | ||||
|---|---|---|---|---|---|---|---|---|---|
| N | % age | N | % age | N | % age | N | % age | ||
| 1 | Prabhuta Mutrata | 10 | 58.82 | 11 | 68.75 | 11 | 61.11 | 32 | 62.74 |
| 2 | Avila Mutrata | 8 | 47.05 | 7 | 43.75 | 10 | 55.55 | 25 | 49.01 |
| 3 | Pipasa-Adhikya | 10 | 58.82 | 11 | 68.75 | 11 | 61.11 | 32 | 62.74 |
| 4 | Kshudha-Adhikya | 9 | 52.94 | 10 | 62.5 | 11 | 61.11 | 30 | 58.82 |
| 5 | Karapadadaha | 9 | 52.94 | 9 | 56.25 | 11 | 61.11 | 29 | 56.86 |
| 6 | Swedadikya | 10 | 58.82 | 9 | 56.25 | 9 | 50 | 28 | 54.9 |
| 7 | Galatalushosha | 10 | 58.82 | 8 | 50 | 8 | 44.44 | 26 | 50.98 |
| 8 | Madhurasya | 1 | 5.88 | 4 | 25 | 2 | 11.11 | 7 | 13.72 |
| 9 | Karapadasuptata | 12 | 70.58 | 9 | 56.25 | 10 | 55.55 | 31 | 60.78 |
| 10 | Shithilangata | 10 | 58.82 | 9 | 56.25 | 11 | 61.11 | 30 | 58.82 |
Table 4. Incidence of signs and symptoms of type 2 diabetes mellitus in registered study subjects
Effect of therapy based on subjective criteria
The effect of therapy on various assessment criteria was obtained after statistical analysis of the data and is presented in Tables 5 and 6.
| S. no. | Symptoms | Group | N | Mean | % relief | SD ± | SE ± | ‘t’ | p value | Significance | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| BT | AT | Diff. | ||||||||||
| 1 | Prabhuta Mutrata | G-I | 15 | 0.8 | 0.267 | 0.533 | 66.62↓ | 0.516 | 0.133 | 4 | 0.001 | S |
| G-II | 15 | 1.133 | 0.467 | 0.667 | 58.78↓ | 0.724 | 0.187 | 3.568 | 0.003 | S | ||
| G-III | 15 | 0.933 | 0.066 | 0.867 | 92.81↓ | 0.915 | 0.236 | 3.666 | 0.003 | S | ||
| 2 | Avila Mutrata | G-I | 15 | 0.733 | 0.267 | 0.467 | 63.57↓ | 0.743 | 0.192 | 2.432 | 0.029 | S |
| G-II | 15 | 0.533 | 0.133 | 0.4 | 75.04↓ | 0.632 | 0.163 | 2.449 | 0.028 | S | ||
| G-III | 15 | 0.867 | 0.133 | 0.733 | 84.65↓ | 0.594 | 0.153 | 4.785 | <0.001 | HS | ||
| 3 | Pipasa-Adhikya | G-I | 15 | 0.867 | 0.267 | 0.6 | 69.20↓ | 0.828 | 0.214 | 2.806 | 0.014 | S |
| G-II | 15 | 1 | 0.333 | 0.667 | 66.70↓ | 0.617 | 0.159 | 4.183 | <0.001 | HS | ||
| G-III | 15 | 0.867 | 0.066 | 0.8 | 92.38↓ | 0.775 | 0.2 | 2.827 | 0.001 | S | ||
| 4 | Kshuda- Adhikya | G-I | 15 | 0.8 | 0.333 | 0.467 | 58.37↓ | 0.64 | 0.165 | 2.824 | 0.014 | S |
| G-II | 15 | 0.933 | 0.2 | 0.733 | 78.56↓ | 0.704 | 0.182 | 4.036 | 0.001 | S | ||
| G-III | 15 | 0.867 | 0.066 | 0.8 | 92.38↓ | 0.775 | 0.2 | 4 | 0.001 | S | ||
| 5 | Karapadadaha | G-I | 15 | 0.733 | 0.333 | 0.4 | 54.57↓ | 0.632 | 0.163 | 2.449 | 0.028 | S |
| G-II | 15 | 0.8 | 0.267 | 0.533 | 66.62↓ | 0.516 | 0.133 | 4 | 0.001 | S | ||
| G-III | 15 | 0.733 | 0.2 | 0.533 | 72.71↓ | 0.64 | 0.165 | 3.228 | 0.006 | S | ||
| 6 | Swedadikya | G-I | 15 | 0.867 | 0.4 | 0.467 | 53.86↓ | 0.743 | 0.192 | 2.432 | 0.029 | S |
| G-II | 15 | 0.867 | 0.333 | 0.533 | 61.59↓ | 0.516 | 0.133 | 4 | 0.001 | S | ||
| G-III | 15 | 0.733 | 0.2 | 0.533 | 72.71↓ | 0.743 | 0.192 | 2.779 | 0.015 | S | ||
| 7 | Galatalushosha | G-I | 15 | 0.733 | 0.467 | 0.267 | 36.28↓ | 0.458 | 0.118 | 2.256 | 0.041 | S |
| G-II | 15 | 0.8 | 0.467 | 0.333 | 41.62↓ | 0.617 | 0.159 | 2.092 | 0.055 | IS | ||
| G-III | 15 | 0.6 | 0.2 | 0.4 | 66.66↓ | 0.507 | 0.131 | 3.055 | 0.009 | S | ||
| 8 | Madhurasya | G-I | 15 | 0.066 | 0.066 | 0 | 0 | 0 | 0 | 0 | 1 | IS |
| G-II | 15 | 0.267 | 0.133 | 0.133 | 50.18↓ | 0.352 | 0.09 | 1.468 | 0.164 | IS | ||
| G-III | 15 | 0.133 | 0.066 | 0.066 | 50.37↓ | 0.258 | 0.066 | 1 | 0.334 | IS | ||
| 9 | Karapadasuptata | G-I | 15 | 0.933 | 0.6 | 0.333 | 35.69↓ | 0.488 | 0.126 | 2.646 | 0.019 | S |
| G-II | 15 | 0.733 | 0.267 | 0.467 | 63.57↓ | 0.516 | 0.133 | 3.5 | 0.004 | S | ||
| G-III | 15 | 0.867 | 0.333 | 0.533 | 61.59↓ | 0.516 | 0.133 | 4 | 0.001 | S | ||
| 10 | Shithilangata | G-I | 15 | 0.533 | 0.2 | 0.333 | 62.47↓ | 0.488 | 0.126 | 2.646 | 0.019 | S |
| G-II | 15 | 0.533 | 0.133 | 0.4 | 75.04↓ | 0.507 | 0.131 | 3.055 | 0.009 | S | ||
| G-III | 15 | 0.667 | 0.066 | 0.6 | 90.10↓ | 0.507 | 0.131 | 4.583 | <0.001 | HS | ||
| Note: ↑: Increase, ↓: Decrease, IS: Insignificant, S: Significant, HS: Highly Significant | ||||||||||||
Table 5. Effect of therapy on subjective parameters
| Comparison | % age relief | Diff. of % age relief | SD | SE | ‘t’ | p value | Significance | |
|---|---|---|---|---|---|---|---|---|
| Prabhuta Mutrata | ||||||||
| GP I vs. II | G-I | 66.62% | 7.84% | 0.65 | 0.24 | -0.53 | 0.566 | IS |
| G-II | 58.78% | |||||||
| GP II vs. III | G-II | 58.78% | -34.03% | 0.85 | 0.32 | -0.61 | 0.512 | IS |
| G-III | 92.81% | |||||||
| GP I vs. III | G-I | 66.62% | -26.19% | 0.77 | 0.29 | -1.14 | 0.23 | IS |
| G-III | 92.81% | |||||||
| Avila Mutrata | ||||||||
| GP I vs. II | G-I | 63.57% | -11.47% | 0.71 | 0.27 | 0.24 | 0.793 | IS |
| G-II | 75.04% | |||||||
| GP II vs. III | G-II | 75.04% | -9.61% | 0.63 | 0.24 | -1.38 | 0.148 | IS |
| G-III | 84.65% | |||||||
| GP I vs. III | G-I | 63.57% | -21.08% | 0.69 | 0.26 | -1 | 0.287 | IS |
| G-III | 84.65% | |||||||
| Pipasa-Adhikya | ||||||||
| GP I vs. II | G-I | 69.20% | 2.50% | 0.75 | 0.28 | -0.23 | 0.804 | IS |
| G-II | 66.70% | |||||||
| GP II vs. III | G-II | 66.70% | -25.60% | 0.72 | 0.27 | -0.48 | 0.606 | IS |
| G-III | 92.38% | |||||||
| GP I vs. III | G-I | 69.20% | -23.18% | 0.83 | 0.31 | -0.63 | 0.5 | IS |
| G-III | 92.38% | |||||||
| Kshuda-Adhikya | ||||||||
| GP I vs. II | G-I | 58.37% | -20.19% | 0.69 | 0.26 | -1 | 0.287 | IS |
| G-II | 78.56% | |||||||
| GP II vs. III | G-II | 78.56% | -13.82% | 0.76 | 0.29 | -0.22 | 0.807 | IS |
| G-III | 92.38% | |||||||
| GP I vs. III | G-I | 58.37% | -34.01% | 0.73 | 0.27 | -1.19 | 0.209 | IS |
| G-III | 92.38% | |||||||
| Karpada Daha | ||||||||
| GP I vs. II | G-I | 35.69% | -27.88% | 0.59 | 0.22 | -0.58 | 0.532 | IS |
| G-II | 63.57% | |||||||
| GP II vs. III | G-II | 66.62% | -6.09% | 0.6 | 0.22 | 0 | 1 | IS |
| G-III | 72.71% | |||||||
| GP I vs. III | G-I | 35.69% | -37.02% | 0.66 | 0.25 | -0.53 | 0.571 | IS |
| G-III | 72.71% | |||||||
| Swedadikya | ||||||||
| GP I vs. II | G-I | 53.86% | -7.73% | 0.66 | 0.25 | -0.26 | 0.778 | IS |
| G-II | 61.59% | |||||||
| GP II vs. III | G-II | 61.59% | -11.12% | 0.66 | 0.25 | 0 | 1 | IS |
| G-III | 72.71% | |||||||
| GP I vs. III | G-I | 53.86% | -18.85% | 0.66 | 0.25 | -0.26 | 0.778 | IS |
| G-III | 72.71% | |||||||
| Galatalushosha | ||||||||
| GP I vs. II | G-I | 36.28% | -5.34% | 0.56 | 0.21 | -0.31 | 0.739 | IS |
| G-II | 41.62% | |||||||
| GP II vs. III | G-II | 41.62% | -25.04% | 0.58 | 0.22 | -0.3 | 0.749 | IS |
| G-III | 66.66% | |||||||
| GP I vs. III | G-I | 36.28% | -30.38% | 0.5 | 0.18 | -0.7 | 0.456 | IS |
| G-III | 66.66% | |||||||
| Madhurasya | ||||||||
| GP I vs. II | G-I | 0% | -50.18% | 0.24 | 0.09 | -1.46 | 0.153 | IS |
| G-II | 50.18% | |||||||
| GP II vs. III | G-II | 50.18% | -0.19% | 0.32 | 0.12 | 0.54 | 0.559 | IS |
| G-III | 50.37% | |||||||
| GP I vs. III | G-I | 0% | -50.37% | 0.18 | 0.07 | -0.92 | 0.326 | IS |
| G-III | 50.37% | |||||||
| Karpadasuptata | ||||||||
| GP I vs. II | G-I | 35.69% | -27.88% | 0.52 | 0.19 | -0.67 | 0.473 | IS |
| G-II | 63.57% | |||||||
| GP II vs. III | G-II | 63.57% | 1.98% | 0.53 | 0.2 | -0.32 | 0.726 | IS |
| G-III | 61.59% | |||||||
| GP I vs. III | G-I | 35.69% | -25.9% | 0.52 | 0.19 | -1.01 | 0.285 | IS |
| G-III | 61.59% | |||||||
| Shithilangata | ||||||||
| GP I vs. II | G-I | 62.47% | -9.57% | 0.51 | 0.19 | -0.34 | 0.716 | IS |
| G-II | 75.04% | |||||||
| GP II vs. III | G-II | 75.04% | -15.06% | 0.52 | 0.19 | -1 | 0.289 | IS |
| G-III | 90.10% | |||||||
| GP I vs. III | G-I | 62.47% | -27.63% | 0.51 | 0.19 | -1.36 | 0.153 | IS |
| G-III | 90.10% | |||||||
Table 6. Intergroup comparison of subjective criteria
Effect of therapy based on objective criteria
Tables 7-10 describe the effect of therapy based on objective criteria.
| Objective criteria | Group | N | Mean | % relief | SD ± | SE ± | ‘t’ | p value | Significance | ||
|---|---|---|---|---|---|---|---|---|---|---|---|
| BT | AT | Diff. | |||||||||
| FBS | G-I | 15 | 154.26 | 140.46 | 13.8 | 8.94↓ | 8.64 | 2.23 | 6.18 | <0.001 | HS |
| G-II | 15 | 169.66 | 135.46 | 34.2 | 20.15↓ | 7.8 | 2.01 | 16.97 | <0.001 | HS | |
| G-III | 15 | 165.73 | 125.46 | 40.26 | 24.29↓ | 20.42 | 5.27 | 7.63 | <0.001 | HS | |
| PPBS | G-I | 15 | 222.66 | 197.93 | 24.73 | 11.10↓ | 10.08 | 2.6 | 9.49 | <0.001 | HS |
| G-II | 15 | 229 | 161.06 | 67.93 | 29.66↓ | 25.86 | 6.67 | 10.17 | <0.001 | HS | |
| G-III | 15 | 225.33 | 145.53 | 79.8 | 35.41↓ | 21.87 | 5.64 | 14.13 | <0.001 | HS | |
| HbA1C | G-I | 15 | 7.85 | 7.67 | 0.18 | 2.29↓ | 0.17 | 0.04 | 3.91 | 0.002 | S |
| G-II | 15 | 7.19 | 6.51 | 0.68 | 9.45↓ | 0.43 | 0.11 | 6.01 | <0.001 | HS | |
| G-III | 15 | 7.24 | 6.45 | 0.78 | 10.87↓ | 0.43 | 0.11 | 7.07 | <0.001 | HS | |
| Blood urea | G-I | 15 | 28.06 | 26.66 | 1.4 | 4.98↓ | 5.98 | 1.54 | 0.9 | 0.38 | IS |
| G-II | 15 | 26.8 | 27.4 | -0.6 | -2.23↑ | 3.77 | 0.97 | -0.61 | 0.548 | IS | |
| G-III | 15 | 34.26 | 26.8 | 0.6 | 1.75↓ | 5.71 | 1.47 | 0.4 | 0.556 | IS | |
| Serum creatinine | G-I | 15 | 0.77 | 0.74 | 0.03 | 3.89↓ | 0.17 | 0.04 | 0.6 | 0.689 | IS |
| G-II | 15 | 0.8 | 0.77 | 0.0267 | 3.25↓ | 0.16 | 0.04 | 0.63 | 0.535 | IS | |
| G-III | 15 | 0.81 | 0.81 | 0 | 0 | 0.11 | 0.029 | 0 | 0.103 | IS | |
| SGOT | G-I | 15 | 30.33 | 28.33 | 2 | 6.59↓ | 2.1 | 0.543 | 3.681 | 0.002 | S |
| G-II | 15 | 36.93 | 29 | 7.93 | 21.47↓ | 15.34 | 3.96 | 2.003 | 0.065 | IS | |
| G-III | 15 | 29.6 | 28.13 | 1.46 | 4.95↓ | 2.06 | 0.53 | 2.75 | 0.016 | S | |
| SGPT | G-I | 15 | 27.93 | 25.66 | 2.26 | 8.11↓ | 2.65 | 0.68 | 3.3 | 0.005 | S |
| G-II | 15 | 35.2 | 30.6 | 4.6 | 13.06↓ | 10.86 | 2.8 | 1.64 | 0.123 | IS | |
| G-III | 15 | 31 | 28.53 | 2.46 | 7.90↓ | 3.87 | 0.99 | 2.46 | 0.027 | S | |
| Serum cholesterol | G-I | 15 | 189.2 | 188.66 | 0.53 | 0.28↓ | 10.44 | 2.69 | 0.19 | 0.846 | IS |
| G-II | 15 | 202.73 | 197.2 | 5.53 | 2.72↓ | 13.51 | 3.49 | 1.58 | 0.135 | IS | |
| G-III | 15 | 190.6 | 184.6 | 6 | 3.14↓ | 10.96 | 2.83 | 2.12 | 0.052 | IS | |
| Serum triglycerides | G-I | 15 | 176.13 | 166.66 | 9.46 | 5.37↓ | 34.3 | 8.85 | 1.06 | 0.303 | IS |
| G-II | 15 | 196.6 | 190.66 | 5.93 | 3.01↓ | 17.75 | 4.58 | 1.29 | 0.217 | IS | |
| G-III | 15 | 191 | 187.06 | 3.93 | 2.05↓ | 10.21 | 2.63 | 1.49 | 0.158 | IS | |
| Serum LDL | G-I | 15 | 111 | 104.13 | 6.87 | 6.18↓ | 18.77 | 4.84 | 1.41 | 0.175 | 1S |
| G-II | 15 | 120.4 | 115.4 | 5 | 4.15↓ | 14.22 | 3.67 | 1.36 | 0.195 | 1S | |
| G-III | 15 | 121.4 | 119.73 | 1.66 | 1.37↓ | 5.38 | 1.38 | 1.2 | 0.25 | 1S | |
| Serum HDL | G-I | 15 | 41.13 | 43.66 | -2.53 | -6.15↑ | 6.25 | 1.61 | -1.56 | 0.139 | IS |
| G-II | 15 | 46.86 | 54.86 | -8 | -17.07↑ | 15.57 | 4.02 | -1.98 | 0.067 | IS | |
| G-III | 15 | 42.06 | 46.53 | -4.46 | -10.60↑ | 12.06 | 3.11 | -1.43 | 0.174 | IS | |
| Haemoglobin | G-I | 15 | 12.53 | 12.69 | -0.16 | -1.28↑ | 0.82 | 0.21 | -0.84 | 0.414 | IS |
| G-II | 15 | 13.22 | 13.37 | -0.15 | -1.13↑ | 0.64 | 0.16 | 0.15 | 0.876 | IS | |
| G-III | 15 | 12.01 | 11.98 | 0.03 | 0.24↓ | 0.5 | 0.13 | 0.25 | 0.803 | IS | |
| TLC | G-I | 15 | 7120 | 7046 | 74 | 1.04↓ | 249.18 | 64.34 | 0.16 | 0.872 | IS |
| G-II | 15 | 7540 | 7413 | 127 | 6.25↓ | 465.16 | 120.1 | 1.26 | 0.228 | IS | |
| G-III | 15 | 7926 | 7320 | 606 | 7.65↓ | 1864.5 | 481.4 | 2.37 | 0.235 | IS | |
| Neutrophils | G-I | 15 | 63.61 | 56.73 | 6.88 | 10.81↓ | 11.86 | 3.06 | 2.24 | 0.141 | IS |
| G-II | 15 | 59.43 | 61.41 | -1.98 | -3.33↑ | 5.63 | 1.45 | -1.36 | 0.195 | IS | |
| G-III | 15 | 68.41 | 65.38 | 3.03 | 4.42↓ | 5.981 | 1.54 | 1.96 | 0.07 | IS | |
| Lymphocytes | G-I | 15 | 33.86 | 32.14 | 1.72 | 5.07↓ | 8.078 | 2.08 | 0.97 | 0.348 | IS |
| G-II | 15 | 33.13 | 31.08 | 2.05 | 6.18↓ | 7.158 | 1.84 | 1.13 | 0.275 | IS | |
| G-III | 15 | 27.7 | 27.6 | 0.1 | 0.36↓ | 4.155 | 1.07 | 0.09 | 0.922 | IS | |
| Mixed cells | G-I | 15 | 7.38 | 7.5 | -0.12 | -1.62↑ | 3.27 | 0.84 | -0.14 | 0.889 | IS |
| G-II | 15 | 8.56 | 8.1 | 0.46 | 5.37↓ | 1.36 | 0.35 | 1.31 | 0.211 | IS | |
| G-III | 15 | 7.72 | 7.42 | 0.3 | 3.88↓ | 1.336 | 0.34 | 0.85 | 0.409 | IS | |
| ESR | G-I | 15 | 21.73 | 15.46 | 6.27 | 28.80↓ | 12.85 | 3.32 | 1.88 | 0.08 | IS |
| G-II | 15 | 15.8 | 11.73 | 4.07 | 25.75↓ | 6.307 | 1.62 | 2.49 | 0.126 | IS | |
| G-III | 15 | 29.4 | 16.46 | 12.94 | 44.01↓ | 17.42 | 4.49 | 2.87 | 0.062 | IS | |
| Urine sugar | G-I | 15 | 0.33 | 0.26 | 0.066 | 20.12↓ | 0.25 | 0.06 | 1 | 0.33 | IS |
| G-II | 15 | 0.4 | 0.06 | 0.33 | 83.25↓ | 0.61 | 0.15 | 2.09 | 0.05 | IS | |
| G-III | 15 | 0.4 | 0.06 | 0.33 | 83.25↓ | 0.72 | 0.18 | 1.78 | 0.09 | IS | |
| Note: ↑: Increase, ↓: Decrease, IS: Insignificant, S: Significant, HS: Highly Significant | |||||||||||
Table 7. Effect of therapy on objective parameters
| Comparison | % age relief | Diff. of % age relief | SD | SE | ‘t’ | p value | Significance | |
|---|---|---|---|---|---|---|---|---|
| FBS | ||||||||
| GP I vs. II | G-I | 8.94% | -11.21% | 8.38 | 3.11 | -6.54 | <0.001 | HS |
| G-II | 20.15% | |||||||
| GP II vs. III | G-II | 20.15% | -4.14% | 15.74 | 5.85 | -1.03 | 0.292 | IS |
| G-III | 24.29% | |||||||
| GP I vs. III | G-I | 8.94% | -15.35% | 15.96 | 5.93 | -4.45 | <0.001 | HS |
| G-III | 24.29% | |||||||
| PPBS | ||||||||
| GP I vs. II | G-I | 11.10% | -18.56% | 19.99 | 7.42 | -5.81 | <0.001 | HS |
| G-II | 29.66% | |||||||
| GP II vs. III | G-II | 29.66% | -5.75% | 24.55 | 9.12 | -1.37 | 0.166 | IS |
| G-III | 35.41% | |||||||
| GP I vs. III | G-I | 11.10% | -24.31% | 17.34 | 6.44 | -8.54 | <0.001 | HS |
| G-III | 35.41% | |||||||
| HbA1C | ||||||||
| GP I vs. II | G-I | 2.29% | -7.16% | 0.34 | 0.12 | -3.95 | <0.001 | HS |
| G-II | 9.45% | |||||||
| GP II vs. III | G-II | 9.45% | -1.42% | 0.44 | 0.16 | -0.64 | 0.507 | IS |
| G-III | 10.87% | |||||||
| GP I vs. III | G-I | 2.29% | -8.58% | 0.33 | 0.12 | -4.86 | <0.001 | HS |
| G-III | 10.87% | |||||||
| Blood urea | ||||||||
| GP I vs. II | G-I | 4.98% | 7.21% | 5.09 | 1.89 | 1.05 | 0.283 | IS |
| G-II | -2.23% | |||||||
| GP II vs. III | G-II | -2.23% | -3.98% | 4.93 | 1.83 | -0.65 | 0.503 | IS |
| G-III | 1.75% | |||||||
| GP I vs. III | G-I | 4.98% | 3.23% | 5.96 | 2.21 | 0.36 | 0.711 | IS |
| G-III | 1.75% | |||||||
| Serum creatinine | ||||||||
| GP I vs. II | G-I | 3.89% | 0.64% | 0.16 | 0.06 | 0 | 1 | IS |
| G-II | 3.25% | |||||||
| GP II vs. III | G-II | 3.25% | 3.25% | 0.14 | 0.05 | 0.5 | 0.606 | IS |
| G-III | 0.00% | |||||||
| GP I vs. III | G-I | 3.89% | 3.89% | 0.14 | 0.05 | 0.48 | 0.619 | IS |
| G-III | 0.00% | |||||||
| SGOT | ||||||||
| GP I vs. II | G-I | 6.59% | -14.88% | 11.15 | 4.14 | -1.43 | 0.149 | IS |
| G-II | 21.47% | |||||||
| GP II vs. III | G-II | 21.47% | 16.52% | 11.14 | 4.14 | 1.56 | 0.117 | IS |
| G-III | 4.95% | |||||||
| GP I vs. III | G-I | 6.59% | 1.64% | 2.12 | 0.78 | 0.67 | 0.489 | IS |
| G-III | 4.95% | |||||||
| SGPT | ||||||||
| GP I vs. II | G-I | 8.11% | -4.95% | 8.05 | 2.99 | -0.77 | 0.426 | IS |
| G-II | 13.06% | |||||||
| GP II vs. III | G-II | 13.06% | 5.16% | 8.304 | 3.08 | 0.69 | 0.48 | IS |
| G-III | 7.90% | |||||||
| GP I vs. III | G-I | 8.11% | 0.21% | 3.38 | 1.25 | -0.15 | 0.87 | IS |
| G-III | 7.90% | |||||||
| Serum cholesterol | ||||||||
| GP I vs. II | G-I | 0.28% | 2.44% | 8.05 | 2.99 | -0.77 | 0.426 | IS |
| G-II | 2.72% | |||||||
| GP II vs. III | G-II | 2.72% | 0.42% | 8.3 | 3.08 | 0.69 | 0.48 | IS |
| G-III | 3.14% | |||||||
| GP I vs. III | G-I | 0.28% | 2.86% | 3.38 | 1.25 | -0.15 | 0.87 | IS |
| G-III | 3.14% | |||||||
| Serum triglycerides | ||||||||
| GP I vs. II | G-I | 5.37% | 2.35% | 27.81 | 10.33 | 0.34 | 0.726 | IS |
| G-II | 3.02% | |||||||
| GP II vs. III | G-II | 3.02% | 0.95% | 14.75 | 5.48 | 0.36 | 0.708 | IS |
| G-III | 2.06% | |||||||
| GP I vs. III | G-I | 5.37% | 3.31% | 25.77 | 9.57 | 0.57 | 0.554 | IS |
| G-III | 2.06% | |||||||
| LDL | ||||||||
| GP I vs. II | G-I | 6.18% | 2.03% | 16.95 | 6.3 | 0.29 | 0.761 | IS |
| G-II | 4.15% | |||||||
| GP II vs. III | G-II | 4.15% | 2.78% | 10.94 | 4.06 | 0.81 | 0.403 | IS |
| G-III | 1.37% | |||||||
| GP I vs. III | G-I | 6.18% | 4.81% | 14.06 | 5.22 | 0.99 | 0.311 | IS |
| G-III | 1.37% | |||||||
| HDL | ||||||||
| GP I vs. II | G-I | -6.15% | -10.92% | 12.08 | 4.49 | 1.261 | 0.218 | IS |
| G-II | -17.07% | |||||||
| GP II vs. III | G-II | -17.07% | -6.47% | 14.18 | 5.27 | -0.695 | 0.493 | IS |
| G-III | -10.60% | |||||||
| GP I vs. III | G-I | -6.15% | -4.45% | 9.78 | 3.63 | 0.551 | 0.586 | IS |
| G-III | -10.60% | |||||||
Table 8. Inter group comparison of effect of therapy on biochemical parameters
| Comparison | % age relief | Diff. of % age relief | SD | SE | ‘t’ | p value | Significance | |
|---|---|---|---|---|---|---|---|---|
| GP I vs. II | G-I | 20.12% | -63.13% | 0.48 | 0.17 | -1.48 | 0.134 | IS |
| G-II | 83.25% | |||||||
| GP II vs. III | G-II | 83.25% | 0% | 0.68 | 0.25 | 0 | 1 | IS |
| G-III | 83.25% | |||||||
| GP I vs. III | G-I | 20.12% | -63.13% | 0.55 | 0.2 | -1.29 | 0.19 | IS |
| G-III | 83.25% | |||||||
Table 9. Intergroup comparison of effect of therapy on urine sugar
| Comparison | % age relief | Diff. of % age relief | SD | SE | ‘t’ | p value | Significance | |
|---|---|---|---|---|---|---|---|---|
| Haemoglobin | ||||||||
| GP I vs. II | G-I | -1.28% | -0.15% | 0.75 | 0.28 | -0.73 | 0.453 | IS |
| G-II | -1.13% | |||||||
| GP II vs. III | G-II | -1.13% | -0.89% | 0.59 | 0.22 | -0.03 | 0.975 | IS |
| G-III | 0.24% | |||||||
| GP I vs. III | G-I | -1.28% | -1.52% | 0.69 | 0.25 | -0.82 | 0.402 | IS |
| G-III | 0.24% | |||||||
| TLC | ||||||||
| GP I vs. II | G-I | 1.04% | -5.21% | 2542.47 | 944.81 | -0.5 | 0.603 | IS |
| G-II | 6.25% | |||||||
| GP II vs. III | G-II | 6.25% | -1.40% | 1670.51 | 620.78 | -0.38 | 0.692 | IS |
| G-III | 7.65% | |||||||
| GP I vs. III | G-I | 1.04% | -6.61% | 2376.9 | 883.28 | -0.81 | 0.406 | IS |
| G-III | 7.65% | |||||||
| Neutrophils | ||||||||
| GP I vs. II | G-I | 10.81% | 14.14% | 9.45 | 3.51 | 2.52 | 0.014 | S |
| G-II | -3.33% | |||||||
| GP II vs. III | G-II | -3.33% | -37.75% | 5.91 | 2.19 | -2.27 | 0.026 | S |
| G-III | 4.42% | |||||||
| GP I vs. III | G-I | 10.81% | 6.39% | 9.56 | 3.55 | 1.08 | 0.271 | IS |
| G-III | 4.42% | |||||||
| Lymphocytes | ||||||||
| GP I vs. II | G-I | 5.07% | -1.11% | 0.28 | 4.601 | -1.973 | 0.059 | IS |
| G-II | 6.18% | |||||||
| GP II vs. III | G-II | 6.18% | 5.82% | 0.31 | 0.312 | 0.977 | 0.337 | IS |
| G-III | 0.36% | |||||||
| GP I vs. III | G-I | 5.07% | 4.71% | 0.48 | 3.234 | -1.746 | 0.092 | IS |
| G-III | 0.36% | |||||||
| Mixed cells | ||||||||
| GP I vs. II | G-I | -1.62% | -6.99% | 2.54 | 0.94 | 0.43 | 0.654 | IS |
| G-II | 5.37% | |||||||
| GP II vs. III | G-II | 5.37% | 1.49% | 2.55 | 0.94 | -0.61 | 0.532 | IS |
| G-III | 3.88% | |||||||
| GP I vs. III | G-I | -1.62% | -5.50% | 1.37 | 0.51 | -0.32 | 0.737 | IS |
| G-III | 3.88% | |||||||
| ESR | ||||||||
| GP I vs. II | G-I | 28.80% | 3.05% | 10.31 | 3.83 | 0.57 | 0.557 | IS |
| G-II | 25.75% | |||||||
| GP II vs. III | G-II | 25.75% | -18.26% | 13.34 | 4.95 | -1.78 | 0.074 | IS |
| G-III | 44.01% | |||||||
| GP I vs. III | G-I | 28.80% | -15.21% | 15.59 | 5.79 | -1.15 | 0.19 | IS |
| G-III | 44.01% | |||||||
Table 10. Inter group comparison of effect of therapy on hematological parameters
Effect of therapy on subjective criteria signs and symptoms
In the present clinical study Prabhuta Mutrata (Polyuria) occurs due to osmotic diuresis which in turn is due to hyperglycaemia. There was 92.81 % reduction in mean score of Prabhuta Mutrata, which was statistically significant (p<0.05) in group III. In group I and II there was reduction of 66.62% and 58.78% in mean score of Prabhuta Mutrata respectively, which was also statistically significant (p<0.05). On intergroup comparison, there was statistically insignificant difference (p>0.05) between group I, II and III [15].
Avila-Mutrata (Turbid urine) occurs due to the presence of sugar or protein in the urine and sometimes due to urinary tract infection. In the present study there was 84.65% reduction in mean score of Avila Mutrata which was statistically highly significant (p<0.001) in group III. Whereas in group I and II there was reduction of 63.57% and 75.04% in mean score of Avila Mutrata respectively, which was statistically significant (p<0.05). On intergroup comparison, there was statistically insignificant difference (p>0.05) between group I, II and III [16].
Pipasa-Adhikya (Polydipsia) is due to Pittavriddhi and Udaka Kshaya i.e. loss of Udaka Dhatu through Mutra. The intense thirst appears because of obligatory renal water loss combined with hyper osmolarity resulting from the increased level of glucose in the blood tending to deplete the intra cellular water, triggering the osmo-receptors in the thirst center of the brain. There was 66.7% reduction in mean score of Pipasa Adhikya which was statistically highly significant (p<0.001) in group II. In group I and III there was reduction of 69.20% and 92.38% in mean score of Pipasa Adhikya respectively, which was statistically significant (i.e., p<0.05, p=0.001 respectively). On intergroup comparison, there was statistically insignificant difference (p>0.05) between group I, II and III [17-19].
In uncontrolled diabetes where blood glucose level remains abnormally high, glucose from the blood cannot enter the cells due to either a lack of insulin or insulin resistance. So, the body can't convert the food into energy. The lack of energy causes an increase in hunger i.e., Kshuda-Adhikya. In the present study there was 92.3%, 78.56% and 58.3% reduction in mean score of Kshuda-Adhikya which was statistically significant in group III (p=0.001), II (p=0.001) and group I (p<0.05) respectively. On intergroup comparison, the result was statistically insignificant between group I, II and III (p>0.05) [20].
Karapada Daha is a Purvarupa of Prameha which continue even in Rupa stage. Pitta and Vata Dosha plays a dominant role in causation of the symptom. The interventional trial drug contains Pitta-Vatahara drugs which cause the alleviation of Pitta as well as Vata Dosha leading to the subsidence of Karapada Daha. In modern science, it is explained that this symptom is a feature of Diabetic neuropathy.
In the present study there was 72.71%, 66.62% and 54.57% reduction in mean score of Karapada Daha which was statistically significant in group III (p<0.05), II (p=0.001) and group I (p<0.05) respectively. On intergroup comparison, the result was statistically insignificant between group I, II and III (p>0.05) [21].
Swedadikya is due to Pitta Prakopa and Medomala Vriddhi in the study subjects of Santarpanottha Prameha. In the present study there was 72.71%, 61.59% and 53.86% reduction in mean score of Swedadikya which was statistically significant in group III (p<0.05), II (p=0.001) and group I (p<0.05) respectively. On intergroup comparison, the result was statistically insignificant between group I, II and III (p >0.05).
Gala-Talushosha (Dryness in oral cavity) is a symptom follows from the feature Pipasa (polydipsia) and is caused by excessive loss of water through urine. In the present study there was 66.66% and 41.62% reduction in mean score of Gala-Talushosha which was statistically significant in group III (p<0.05) and group I (p<0.05) respectively. In group I it was statistically insignificant. On intergroup comparison, the result was statistically insignificant between group I, II and III (p >0.05).
Madhurasyata (Sweetness in Mouth) is felt due to excess glucose in blood causing persistent salivation of the mouth. This symptom is found most frequent in all diabetics. In the present study only few (i.e., 7) study subjects in all three groups presented with the feature of Madhurasyata and all three groups showed statistically insignificant (p>0.05) results. On intergroup comparison, the result was statistically insignificant between group I, II and III (p >0.05).
Karapada Suptata (Numbness) is also a feature of hyperglycemia induced neuropathy. In the present study there was 61.59%, 63.57% and 35.69% reduction in mean score of Karapada Suptata which was statistically significant in group III (p=0.001), II (p<0.05) and group I (p<0.05) respectively. On intergroup comparison, the result was statistically insignificant between group I, II and III (p >0.05).
Excessive production of Shareera Kleda leads to the manifestation of Shithilangata. This is the most common symptom found frequently in almost all diabetics resulting from excessive loss of electrolytes through urine and also due to less glucose supply to the cells and thus causing fatigue and lethargy in the diabetic study subjects. In this study there was 90.10% reduction in mean score of Shithilangata which was statistically highly significant (p<0.001) in group III. Whereas in group II and I, there was reduction of 75.04% and 62.47% in mean score of Shitilangata respectively, which was statistically significant (i.e., p<0.05). On intergroup comparison, the result was statistically insignificant between group I, II and III (p>0.05).
Effect of therapy on objective criteria
On F.B.S., P.P.B.S., HbA1C and Urine sugar: Fasting blood sugar: In the present clinical study the mean score of FBS in group I, II and III before treatment was 154.26, 169.66, 165.73 mg/dl and after treatment it was 140.46, 135.46 and 125.46 mg/dl giving 8.94%, 20.15%, 24.29% reduction in mean score respectively, which was statistically highly significant (p<0.001) in group I, II and III. The FBS levels significantly decreased in all groups but maximum decrease was found in group III (24.29%) after three months of treatment. On intergroup comparison, the result was statistically highly significant (p<0.001) between group I-II and group I-III and was statistically insignificant between group II-III (p>0.05).
Post prandial blood sugar: In the present clinical study the mean score of PPBS in group I, II and III before treatment was 222.66, 229.0, 225.33 mg/dl and after treatment it was 197.93, 161.06 and 145.53 mg/dl giving 11.10%, 29.66% and 35.41% reduction in mean score respectively, which was statistically highly significant (p<0.001) in group I, II and III. The PPBS level significantly decreased in all groups but maximum decrease found in group III (35.41%) after three months of treatment. On intergroup comparison, the result was statistically highly significant (p<0.001) between group I-II and group I-III and was statistically insignificant between group II-III (p>0.05).
Glycosylated haemoglobin/HbA1C: In the present clinical study the mean score of HbA1c in group I, II and III before treatment was 7.85, 7.19, 7.24 and after treatment it was 7.67, 6.51 and 6.45 giving 2.29%, 9.45% and 10.87% reduction in mean score respectively, which was statistically highly significant (p<0.001) in group II and III and statistically significant in group I (p<0.05). On intergroup comparison, the result was statistically highly significant (p<0.001) between group I-II and group I-III and was statistically insignificant between group II-III (p>0.05). The HbA1c level significantly decreased in all groups but maximum decrease was found in group III (i.e., 10.87%). This shows the significant effect of Pramehhara Kwatha in reducing the HbA1c level.
Urine sugar: In the present clinical study only a few enrolled study subjects had glycosuria, the mean score of urine sugar in group I, II and III before treatment was 0.33, 0.40 and 0.40 and after treatment it came to 0.26, 0.06 and 0.066 giving 20.12%, 83.25 % and 83.25% reduction in mean score respectively which was statistically insignificant (p>0.05) in all three groups. On intergroup comparison, there was a statistically insignificant difference (p>0.05).
Effect of Therapy on other Haematological and Biochemical Parameters
In the present study, no considerable change was noticed in Hb, TLC, DLC, ESR, FBS, blood urea and serum creatinine after treatment in both the groups. But significant change was noticed in SGOT and SGPT level after treatment.
SGOT: In the present clinical study the mean score of SGOT in Group I, II and III before treatment was 30.33 IU/L, 36.93 IU/L, 29.60 IU/L and after treatment it was 28.33 IU/L, 29.00 IU/L and 28.13 IU/L giving 6.59%, 21.47% and 4.95% reduction in mean score respectively which was statistically significant in group I and III (p<0.05) and was statistically insignificant in group II (p>0.05). Reduction in the levels of SGOT suggests that there must be some hepatoprotective effects of Pramehhara Kwatha also. On intergroup comparison, there was statistically insignificant difference between group I, II and III (p>0.05).
SGPT: In the present clinical study the mean score of SGPT in group I, II and III before treatment was 27.93 IU/L, 35.20 IU/L, 31 IU/L and after treatment it was 25.66 IU/L, 30.60 IU/L and 28.53 IU/L giving 8.11%, 13.06% and 7.9% reduction in mean score respectively which was statistically significant in group I and III (p<0.05) and was statistically insignificant in group II (p>0.05). Reduction in the levels of SGPT suggests that there must be some hepatoprotective effects of Pramehhara Kwatha also. On intergroup comparison, there was statistically insignificant difference between group I, II and III (p>0.05).
Discussion
Probable mode of action of Pramehhara Kwatha can be explained on the following basis: As per the fundamental principles of Ayurveda the mode of action of every drug is determined by the dominant pharmacodynamic factor in that particular drug and that may be Rasa, Guna, Veerya, Vipaka or Prabhava.
In Ayurvedic classics, it has been clearly mentioned that Kapha and Vata play important role in the pathogenesis of Madhumeha. In Sushruta Samhita while describing the principle of management of Madhumeha it has been mentioned that the drugs which have Tikta, Katu, and Kashaya Rasa, Katu Vipaka and Ushna Veerya with Soshaka and Chedana actions are useful in the treatment of Madhumeha. As vitiated Kapha is initiating Dosha in Prameha or Madhumeha and Dushyas are also of the same nature, so the drugs used in Madhumeha treatment must possess the above-mentioned properties in order to maintain equilibrium between Vata and Kapha. In the present study, a combination of 5 herbs was used to assess its efficacy in the management of Madhumeha. Majority of the drugs in the formulation are having Katu and Tikta Rasa. Katu Rasa is Agni Mahabhuta predominant. It has got Deepana, Pachana, Srothoshodhana, Kapha Shamana action and causes Shoshana of Kleda and Meda. Since the Samprapti begins with Kapha Prakopa and Mala Sanchaya hence, Kapha Shamanatva and Srothoshodhana are absolutely essential for Samprapati Vighattan. Also majority of the ingredients of trial formulation possess Laghu and Ruksha Guna which is dominant in Akasha, Agni and Vayu Mahabhuta. It is Laghavakara, Kaphagna and Lekhana. This results in alleviation of aggravated Kapha and causes Apatarpana. It also aids to Deepana and Pachana. Ruksha Guna which is dominant in all the ingredients of trial formulation has Sroto Shodhaka property. Ruksha Guna helps in cleaning all Srotas, therefore, decreases Prabhuta Mutrata as it possesses Dravansh Shoshaka property. Sheeta Guna which is dominant in Amalaki and Mustaka pacifies Pitta which further subsides symptoms like Pipasadhikya, Kshudhadhikya, Kara Pada Daha, Gala Talu Shosha, Swedadhikya and Shithilangata. Ushna Virya of majority of drugs leads to Kapha Shamana. which aids in Srothoshodhana, Anulomana, correction of Agni, Ama Pachana and prevents Kapha and Malasanchaya.
Methanolic extract and chloroform extract of T. chebula decrease the blood sugar level. Principal constituents of Vibhitaki are ß- sitosterol, gallic acid leads to increase in the plasma insulin, C-peptide and glucose tolerance levels. Amalaki has high amount of vitamin C content in its fruit which reduces the sugar level in blood. It stimulates the islets of Langerhans i.e., the isolated Group of cells which secrete hormone insulin. The major chemical constituents present in B. Aristata plant are alkaloids and the main one i.e., isoquinoline berberine which has been shown to affect blood glucose levels. Berberine has also effects on blood glucose level similar to the drug Metformin in improving insulin resistance. The major chemical constituents present in cyperus rotundus are Cyperen 1 and 2, eplerenone, isopatchoulenone significantly lowered blood sugar levels in alloxan- induced hyperglycemic rats.
Conclusions
After the careful review of the results obtained from the clinical study following conclusion can be drawn:
• The trial drug i.e., Pramehhara Kwatha showed statistically significant results on subjective parameters i.e., Prabhuta Mutrata, Avila Mutrata, Pipasa-Adhikya, Kshuda-Adhikya, Karapada Daha, Swedadikya, Galatalusosha, Madhurasyata, Karapadasuptata and Shithilangata.
• There was statistically highly significant decrease of FBS, PPBS and HbA1c levels in all three groups but maximum decrease was observed in group III, wherein the patients were managed with Pramehhara Kwatha as well as tab. Metformin. This shows the synergistic action of Pramehhara Kwatha along with tab. Metformin in the management of type II diabetes mellitus.
• Various haematological and biochemical parameters i.e., Hbgm%, TLC, DLC, blood urea, serum creatinine and serum lipid profiles remained within the normal limits in all three groups during and after the completion of clinical trial. However, statistically significant reduction of SGOT and SGPT levels after the completion of the trial in group-I and group-III.
• No untoward effects of Pramehhara Kwatha were observed during the entire trial period.
• Thus, on the basis of present clinical study, it may be concluded that Pramehhara Kwatha is efficient in management of Madhumeha and also possess significant hypoglycemic activity.
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