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

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 3
Locations
India
Study Type
Interventional
Intervention
Chhinnavahni Kashaya Vati along with Agnimantha Kwatha
Metformin Hydrochloride
Sponsored by
A & U Tibbia College Karol Bagh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • A and U Tibbia College

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group A

GROUP B

Arm Description

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

Outcomes

Primary Outcome Measures

OBJECTIVE PARAMETERS
1. Blood sugar fasting in Milligrams per decilitre
OBJECTIVE PARAMETERS
Blood sugar post prandial Milligrams per decilitre
OBJECTIVE PARAMETERS
Glycosylated Haemoglobin (HbA1c in %)

Secondary Outcome Measures

SUBJECTIVE PARAMETERS
Polyurea (excessive urine) grading from 0 to 3
SUBJECTIVE PARAMETERS
Unclear / turbid urine grading from 0 to 3
SUBJECTIVE PARAMETERS
Polyphagia( excessive hunger) grading from 0 to 3
SUBJECTIVE PARAMETERS
Polydipsia (excessive thirst) grading from 0 to 3
SUBJECTIVE PARAMETERS
Exhaustion / tiredness grading from 0 to 3
SUBJECTIVE PARAMETERS
Polyneuritis (numbness / tingling/ burning of soles) grading from 0 to 3
SUBJECTIVE PARAMETERS
Cramps while walking/calf muscle pain grading from 0 to 3
SUBJECTIVE PARAMETERS
Constipation grading from 0 to 3
SUBJECTIVE PARAMETERS
Excessive Sweating grading from 0 to 3
SUBJECTIVE PARAMETERS
Excessive Sleeping grading from 0 to 3
SUBJECTIVE PARAMETERS
DSQ grading from 0 to 3

Full Information

First Posted
May 29, 2022
Last Updated
July 5, 2022
Sponsor
A & U Tibbia College Karol Bagh
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1. Study Identification

Unique Protocol Identification Number
NCT05451147
Brief Title
A Comparative Study of the Effect of Ayurvedic Drugs and Metformin in the Management of Diabetes Mellitus (Type II)
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)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
September 3, 2018 (Actual)
Primary Completion Date
April 30, 2019 (Actual)
Study Completion Date
April 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
A & U Tibbia College Karol Bagh

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Randomized, Controlled, Parallel Group Trial.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
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
Arm Title
GROUP B
Arm Type
Active Comparator
Arm Description
DRUG: Metformin FORM: Tablet DOSE: 500mg BID/TDS, Before Meals MODE OF ADMINISTRATION: Oral ANUPAAN:: Plain Water DURATION 3 Months
Intervention Type
Drug
Intervention Name(s)
Chhinnavahni Kashaya Vati along with Agnimantha Kwatha
Other Intervention Name(s)
Chhinnavahni Kashaya Vati, Agnimantha Kwatha
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Metformin Hydrochloride
Other Intervention Name(s)
Metformin
Intervention Description
Drug: Metformin Form: Tablet Dose: 500mg BID/TDS, Before meals Mode of Administration: Oral Anupaan: Plain water Duration: 3 Months
Primary Outcome Measure Information:
Title
OBJECTIVE PARAMETERS
Description
1. Blood sugar fasting in Milligrams per decilitre
Time Frame
Change from Baseline at End of trial [3 month]
Title
OBJECTIVE PARAMETERS
Description
Blood sugar post prandial Milligrams per decilitre
Time Frame
Change from Baseline at End of trial [3 month]
Title
OBJECTIVE PARAMETERS
Description
Glycosylated Haemoglobin (HbA1c in %)
Time Frame
Change from Baseline at End of trial [3 month]
Secondary Outcome Measure Information:
Title
SUBJECTIVE PARAMETERS
Description
Polyurea (excessive urine) grading from 0 to 3
Time Frame
Change from Baseline at End of trial [3 month]
Title
SUBJECTIVE PARAMETERS
Description
Unclear / turbid urine grading from 0 to 3
Time Frame
Change from Baseline at End of trial [3 month]
Title
SUBJECTIVE PARAMETERS
Description
Polyphagia( excessive hunger) grading from 0 to 3
Time Frame
Change from Baseline at End of trial [3 month]
Title
SUBJECTIVE PARAMETERS
Description
Polydipsia (excessive thirst) grading from 0 to 3
Time Frame
Change from Baseline at End of trial [3 month]
Title
SUBJECTIVE PARAMETERS
Description
Exhaustion / tiredness grading from 0 to 3
Time Frame
Change from Baseline at End of trial [3 month]
Title
SUBJECTIVE PARAMETERS
Description
Polyneuritis (numbness / tingling/ burning of soles) grading from 0 to 3
Time Frame
Change from Baseline at End of trial [3 month]
Title
SUBJECTIVE PARAMETERS
Description
Cramps while walking/calf muscle pain grading from 0 to 3
Time Frame
Change from Baseline at End of trial [3 month]
Title
SUBJECTIVE PARAMETERS
Description
Constipation grading from 0 to 3
Time Frame
Change from Baseline at End of trial [3 month]
Title
SUBJECTIVE PARAMETERS
Description
Excessive Sweating grading from 0 to 3
Time Frame
Change from Baseline at End of trial [3 month]
Title
SUBJECTIVE PARAMETERS
Description
Excessive Sleeping grading from 0 to 3
Time Frame
Change from Baseline at End of trial [3 month]
Title
SUBJECTIVE PARAMETERS
Description
DSQ grading from 0 to 3
Time Frame
Change from Baseline at End of trial [3 month]

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Richa Bhardwaj, M.D. (Ayu.)
Organizational Affiliation
A & U Tibbia College
Official's Role
Principal Investigator
Facility Information:
Facility Name
A and U Tibbia College
City
Delhi
ZIP/Postal Code
110005
Country
India

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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