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

• Sponsor: A & U Tibbia College Karol Bagh (Other)
• Overall Status: Completed
• CT.gov ID: NCT05451147
• Collaborator: (none)
• Enrollment: 48
• Location: 1
• Arms: 2
• Actual Duration (Months): 7.9
• Patients Per Site Per Month: 6.1

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	Drug: Chhinnavahni Kashaya Vati along with Agnimantha Kwatha; Drug: Metformin Hydrochloride	Phase 3

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 Design

• Study Type: Interventional
• Actual Enrollment: 48 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized, Controlled, Parallel Group Trial.Randomized, Controlled, Parallel Group Trial.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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)
• Actual Study Start Date: Sep 3, 2018
• Actual Primary Completion Date: Apr 30, 2019
• Actual Study Completion Date: Apr 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group A 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; 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; Other Names: Chhinnavahni Kashaya Vati Agnimantha Kwatha
Active Comparator: GROUP B DRUG: Metformin FORM: Tablet DOSE: 500mg BID/TDS, Before Meals MODE OF ADMINISTRATION: Oral ANUPAAN:: Plain Water DURATION 3 Months	Drug: Metformin Hydrochloride; Drug: Metformin Form: Tablet Dose: 500mg BID/TDS, Before meals Mode of Administration: Oral Anupaan: Plain water Duration: 3 Months; Other Names: Metformin

Outcome Measures

Primary Outcome Measures

1. OBJECTIVE PARAMETERS [Change from Baseline at End of trial [3 month]]

   1. Blood sugar fasting in Milligrams per decilitre

2. OBJECTIVE PARAMETERS [Change from Baseline at End of trial [3 month]]

   Blood sugar post prandial Milligrams per decilitre

3. OBJECTIVE PARAMETERS [Change from Baseline at End of trial [3 month]]

   Glycosylated Haemoglobin (HbA1c in %)

Secondary Outcome Measures

1. SUBJECTIVE PARAMETERS [Change from Baseline at End of trial [3 month]]

   Polyurea (excessive urine) grading from 0 to 3

2. SUBJECTIVE PARAMETERS [Change from Baseline at End of trial [3 month]]

   Unclear / turbid urine grading from 0 to 3

3. SUBJECTIVE PARAMETERS [Change from Baseline at End of trial [3 month]]

   Polyphagia( excessive hunger) grading from 0 to 3

4. SUBJECTIVE PARAMETERS [Change from Baseline at End of trial [3 month]]

   Polydipsia (excessive thirst) grading from 0 to 3

5. SUBJECTIVE PARAMETERS [Change from Baseline at End of trial [3 month]]

   Exhaustion / tiredness grading from 0 to 3

6. SUBJECTIVE PARAMETERS [Change from Baseline at End of trial [3 month]]

   Polyneuritis (numbness / tingling/ burning of soles) grading from 0 to 3

7. SUBJECTIVE PARAMETERS [Change from Baseline at End of trial [3 month]]

   Cramps while walking/calf muscle pain grading from 0 to 3

8. SUBJECTIVE PARAMETERS [Change from Baseline at End of trial [3 month]]

   Constipation grading from 0 to 3

9. SUBJECTIVE PARAMETERS [Change from Baseline at End of trial [3 month]]

   Excessive Sweating grading from 0 to 3

10. SUBJECTIVE PARAMETERS [Change from Baseline at End of trial [3 month]]

    Excessive Sleeping grading from 0 to 3

11. SUBJECTIVE PARAMETERS [Change from Baseline at End of trial [3 month]]

    DSQ grading from 0 to 3

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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).

1. 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)}.

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

3. 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	A and U Tibbia College	Delhi		India	110005

Sponsors and Collaborators

• A & U Tibbia College Karol Bagh

Investigators

• Principal Investigator: Dr. Richa Bhardwaj, M.D. (Ayu.), A & U Tibbia College

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr. Richa Bhardwaj, PG Scholar (Kayachikitsa), A & U Tibbia College Karol Bagh
• ClinicalTrials.gov Identifier: NCT05451147
• Other Study ID Numbers: N.F.5(283)/2013-CO
• First Posted: Jul 11, 2022
• Last Update Posted: Jul 11, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Metformin

Study Results

No Results Posted as of Jul 11, 2022