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

NCT05451147 | Completed Phase 3

• 1 other identifier: N.F.5(283)/2013-CO
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (11)

• SUBJECTIVE PARAMETERS

  Change from Baseline at End of trial [3 month]

• SUBJECTIVE PARAMETERS

  Change from Baseline at End of trial [3 month]

• SUBJECTIVE PARAMETERS

  Change from Baseline at End of trial [3 month]

• SUBJECTIVE PARAMETERS

  Change from Baseline at End of trial [3 month]

• SUBJECTIVE PARAMETERS

  Change from Baseline at End of trial [3 month]

Study Arms (2)

Group A

EXPERIMENTAL

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

GROUP B

ACTIVE COMPARATOR

DRUG: Metformin FORM: Tablet DOSE: 500mg BID/TDS, Before Meals MODE OF ADMINISTRATION: Oral ANUPAAN:: Plain Water DURATION 3 Months

Drug: Metformin Hydrochloride

Interventions

Chhinnavahni Kashaya Vati along with Agnimantha Kwatha DRUG

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

Also known as: Chhinnavahni Kashaya Vati, Agnimantha Kwatha

Group A

Metformin Hydrochloride DRUG

Drug: Metformin Form: Tablet Dose: 500mg BID/TDS, Before meals Mode of Administration: Oral Anupaan: Plain water Duration: 3 Months

Also known as: Metformin

GROUP B

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• A & U Tibbia College Karol Bagh: lead

Study Sites (1)

A and U Tibbia College

Delhi, 110005, India

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Metformin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Dr. Richa Bhardwaj, M.D. (Ayu.)

  A & U Tibbia College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PG Scholar (Kayachikitsa)

Model Details: Randomized, Controlled, Parallel Group Trial.

Study Record Dates

• First Submitted: May 29, 2022
• First Posted: July 11, 2022
• Study Start: September 3, 2018
• Primary Completion: April 30, 2019
• Study Completion: April 30, 2019
• Last Updated: July 11, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)