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

Phase 3

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Chhinnavahni Kashaya Vati along with Agnimantha Kwatha; Drug: Metformin Hydrochloride

• Registration Number: NCT05451147
• Lead Sponsor: A & U Tibbia College Karol Bagh

Brief Summary

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

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.

Study Timeline

• Study Start: 2018-09-03
• Primary Completion: 2019-04-30
• Study Completion: 2019-04-30
• Study First Submitted: 2022-05-29
• Status Verified: 2022-07
• Study First Submitted QC: 2022-07-05
• Last Update Submitted: 2022-07-05
• Study First Posted: 2022-07-11
• Last Update Posted: 2022-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

1. Patients of either sex aged between 20 to 60 years.

2. 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).

3. 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)}.

4. Subjects who are able to come for follow up on fixed visits and are well aware about the treatment plan.

5. Subjects willing to participate and able to provide written informed consent.

Exclusion Criteria

1. Age below 20 and above 60yrs.
2. 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.
3. Subjects suffering from the complications of Diabetes mellitus viz., diabetic neuropathy, diabetic nephropathy, diabetic retinopathy etc. which require an urgent treatment.
4. Uncontrolled Hypertensive subjects (BP with or without medication >140/90 mmHg after 5 mins of rest).
5. Subjects with any unstable Heart disease or known cases of MI, unstable angina or CHF.
6. 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).
7. Subjects with current or past diagnosis of malignancy (any malignancy diagnosis in last five years).
8. Subjects who have a recent history or who are currently known to abuse of alcohol or drugs.
9. Subjects suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Psycho-Neuro-Endocrinal disorders, TB, AIDS etc).
10. 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.
11. Pregnant / Lactating women.
12. Subject on systemic or oral steroids, oral contraceptive pills or estrogen replacement therapy.
13. Subjects having hypersensitivity to any of the trial drug.
14. Subjects who have completed participation in any other clinical trial during the past six (06) months.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Chhinnavahni Kashaya Vati along with Agnimantha Kwatha	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
GROUP B	Metformin Hydrochloride	DRUG: Metformin FORM: Tablet DOSE: 500mg BID/TDS, Before Meals MODE OF ADMINISTRATION: Oral ANUPAAN:: Plain Water DURATION 3 Months

Primary Outcome Measures

Name	Time	Method
OBJECTIVE PARAMETERS	Change from Baseline at End of trial [3 month]	Glycosylated Haemoglobin (HbA1c in %)

Secondary Outcome Measures

Name	Time	Method
SUBJECTIVE PARAMETERS	Change from Baseline at End of trial [3 month]	DSQ grading from 0 to 3

Trial Locations

Locations (1)

A and U Tibbia College; 🇮🇳 Delhi, India