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

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)

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

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: Chhinnavahni Kashaya Vati along with Agnimantha Kwatha; Drug: Metformin Hydrochloride

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 Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 3

Contacts and Locations

Study Locations

• India
  • Delhi, India, 110005
    • A and U Tibbia College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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]

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): September 3, 2018
• Primary Completion (Actual): April 30, 2019
• Study Completion (Actual): April 30, 2019

Study Registration Dates

• First Submitted: May 29, 2022
• First Submitted That Met QC Criteria: July 5, 2022
• First Posted (Actual): July 11, 2022

Study Record Updates

• Last Update Posted (Actual): July 11, 2022
• Last Update Submitted That Met QC Criteria: July 5, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Metformin
• Other Study ID Numbers: N.F.5(283)/2013-CO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No