A Comparative Study of the Effect of Ayurvedic Drugs and Metformin in the Management of Diabetes Mellitus (Type II)

Study Overview
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Brief Summary
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Present study entitled A Comparative Study of the Effect of Chhinnavahni Kashaya Vati along with Agnimantha Kwatha & Metformin in the management of Madhumeha w.s.r. to Diabetes mellitus (Type II) is a small effort to find out an effective remedy for Madhumeha i.e. Diabetes Mellitus Type-2

Detailed Description
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Single centered, randomized clinical trial of Chhinnavahni Kashaya Vati along with Agnimantha Kwatha was carried out on total of 60 registered patients. They were randomly classified in two groups, where in Group-A received Chhinnavahni Kashaya Vati with Agnimantha Kwatha and Group-B received Metformin for 12 weeks. Out of these, 12 patients did not complete the full course of the treatment.

Official Title
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A Comparative Study of the Effect of Chhinnavahni Kashaya Vati Along With Agnimantha Kwatha & Metformin in the Management of Madhumeha w.s.r. to Diabetes Mellitus (Type II)

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Chhinnavahni Kashaya Vati along with Agnimantha Kwatha
* Drug: Metformin Hydrochloride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients of either sex aged between 20 to 60 years. If yes in any two of the four: Blood sugar -fasting > 126 and ≤ 250 mg/dl. PP > 200 mg/dl and ≤350 mg/dl. Glycosylated Haemoglobin (HbA1c) > 6.5% and < 9%. Subjects having classical symptoms of diabetes with random glucose levels ≥200mg/dl (≤350mg/dl). Diagnosed cases of Type II Diabetics having Glycosylated Haemoglobin (HbA1c) between 6.5-9% without or {with metformin in a dose1g-1.5g/day (for Group-B)}. Subjects who are able to come for follow up on fixed visits and are well aware about the treatment plan. Subjects willing to participate and able to provide written informed consent. Exclusion Criteria: Age below 20 and above 60yrs. Subject of Type-I DM (insulin dependent DM) or Type-II DM on insulin/OHA's other than metformin/ any other AYUSH medication for glucose control. Subjects suffering from the complications of Diabetes mellitus viz., diabetic neuropathy, diabetic nephropathy, diabetic retinopathy etc. which require an urgent treatment. Uncontrolled Hypertensive subjects (BP with or without medication >140/90 mmHg after 5 mins of rest). Subjects with any unstable Heart disease or known cases of MI, unstable angina or CHF. Patients with concurrent Hepatic Dysfunction (defined as AST and/or ALT > 2 times of the upper normal limit) or Renal Dysfunction, uncontrolled Pulmonary Dysfunction (asthmatic and COPD subjects). Subjects with current or past diagnosis of malignancy (any malignancy diagnosis in last five years). Subjects who have a recent history or who are currently known to abuse of alcohol or drugs. Subjects suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Psycho-Neuro-Endocrinal disorders, TB, AIDS etc). Female subject of child bearing potential who do not agree to remain abstinent or use medically acceptable methods of contraception during the study therapy and for 4 weeks after the end of study therapy. Pregnant / Lactating women. Subject on systemic or oral steroids, oral contraceptive pills or estrogen replacement therapy. Subjects having hypersensitivity to any of the trial drug. Subjects who have completed participation in any other clinical trial during the past six (06) months.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, Controlled, Parallel Group Trial.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>DRUG: Chhinnavahni Kashaya Vati FORM: Tablet DOSE: 1 g TDS (2 Tab. of 500 mg each), Before Meals MODE OF ADMINISTRATION: Oral ANUPAAN: 20 ml of Agnimantha Kwatha DURATION: 3 Months | Drug: Chhinnavahni Kashaya Vati along with Agnimantha Kwatha<br>* Drug: Chhinnavahni Kashaya Vati Form : Tablet Dose: 1g TDS (2x500 mg), Before meals Mode of Administration: Oral Anupaan: 20 ml of Agnimantha Kwatha Duration: 3 Months<br>* Other names: Agnimantha Kwatha;|
| Active Comparator: GROUP B<br>DRUG: Metformin FORM: Tablet DOSE: 500mg BID/TDS, Before Meals MODE OF ADMINISTRATION: Oral ANUPAAN:: Plain Water DURATION 3 Months | Drug: Metformin Hydrochloride<br>* Drug: Metformin Form: Tablet Dose: 500mg BID/TDS, Before meals Mode of Administration: Oral Anupaan: Plain water Duration: 3 Months<br>* Other names: Metformin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OBJECTIVE PARAMETERS | 1. Blood sugar fasting in Milligrams per decilitre | Change from Baseline at End of trial [3 month] | 
| OBJECTIVE PARAMETERS | Blood sugar post prandial Milligrams per decilitre | Change from Baseline at End of trial [3 month] | 
| OBJECTIVE PARAMETERS | Glycosylated Haemoglobin (HbA1c in %) | Change from Baseline at End of trial [3 month] | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SUBJECTIVE PARAMETERS | Polyurea (excessive urine) grading from 0 to 3 | Change from Baseline at End of trial [3 month] | 
| SUBJECTIVE PARAMETERS | Unclear / turbid urine grading from 0 to 3 | Change from Baseline at End of trial [3 month] | 
| SUBJECTIVE PARAMETERS | Polyphagia( excessive hunger) grading from 0 to 3 | Change from Baseline at End of trial [3 month] | 
| SUBJECTIVE PARAMETERS | Polydipsia (excessive thirst) grading from 0 to 3 | Change from Baseline at End of trial [3 month] | 
| SUBJECTIVE PARAMETERS | Exhaustion / tiredness grading from 0 to 3 | Change from Baseline at End of trial [3 month] | 
| SUBJECTIVE PARAMETERS | Polyneuritis (numbness / tingling/ burning of soles) grading from 0 to 3 | Change from Baseline at End of trial [3 month] | 
| SUBJECTIVE PARAMETERS | Cramps while walking/calf muscle pain grading from 0 to 3 | Change from Baseline at End of trial [3 month] | 
| SUBJECTIVE PARAMETERS | Constipation grading from 0 to 3 | Change from Baseline at End of trial [3 month] | 
| SUBJECTIVE PARAMETERS | Excessive Sweating grading from 0 to 3 | Change from Baseline at End of trial [3 month] | 
| SUBJECTIVE PARAMETERS | Excessive Sleeping grading from 0 to 3 | Change from Baseline at End of trial [3 month] | 
| SUBJECTIVE PARAMETERS | DSQ grading from 0 to 3 | Change from Baseline at End of trial [3 month] |