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

July 5, 2022 updated by: Dr. Richa Bhardwaj, A & U Tibbia College Karol Bagh

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years to 56 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
OBJECTIVE PARAMETERS
Time Frame: Change from Baseline at End of trial [3 month]
1. Blood sugar fasting in Milligrams per decilitre
Change from Baseline at End of trial [3 month]
OBJECTIVE PARAMETERS
Time Frame: Change from Baseline at End of trial [3 month]
Blood sugar post prandial Milligrams per decilitre
Change from Baseline at End of trial [3 month]
OBJECTIVE PARAMETERS
Time Frame: Change from Baseline at End of trial [3 month]
Glycosylated Haemoglobin (HbA1c in %)
Change from Baseline at End of trial [3 month]

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
SUBJECTIVE PARAMETERS
Time Frame: Change from Baseline at End of trial [3 month]
Polyurea (excessive urine) grading from 0 to 3
Change from Baseline at End of trial [3 month]
SUBJECTIVE PARAMETERS
Time Frame: Change from Baseline at End of trial [3 month]
Unclear / turbid urine grading from 0 to 3
Change from Baseline at End of trial [3 month]
SUBJECTIVE PARAMETERS
Time Frame: Change from Baseline at End of trial [3 month]
Polyphagia( excessive hunger) grading from 0 to 3
Change from Baseline at End of trial [3 month]
SUBJECTIVE PARAMETERS
Time Frame: Change from Baseline at End of trial [3 month]
Polydipsia (excessive thirst) grading from 0 to 3
Change from Baseline at End of trial [3 month]
SUBJECTIVE PARAMETERS
Time Frame: Change from Baseline at End of trial [3 month]
Exhaustion / tiredness grading from 0 to 3
Change from Baseline at End of trial [3 month]
SUBJECTIVE PARAMETERS
Time Frame: Change from Baseline at End of trial [3 month]
Polyneuritis (numbness / tingling/ burning of soles) grading from 0 to 3
Change from Baseline at End of trial [3 month]
SUBJECTIVE PARAMETERS
Time Frame: Change from Baseline at End of trial [3 month]
Cramps while walking/calf muscle pain grading from 0 to 3
Change from Baseline at End of trial [3 month]
SUBJECTIVE PARAMETERS
Time Frame: Change from Baseline at End of trial [3 month]
Constipation grading from 0 to 3
Change from Baseline at End of trial [3 month]
SUBJECTIVE PARAMETERS
Time Frame: Change from Baseline at End of trial [3 month]
Excessive Sweating grading from 0 to 3
Change from Baseline at End of trial [3 month]
SUBJECTIVE PARAMETERS
Time Frame: Change from Baseline at End of trial [3 month]
Excessive Sleeping grading from 0 to 3
Change from Baseline at End of trial [3 month]
SUBJECTIVE PARAMETERS
Time Frame: Change from Baseline at End of trial [3 month]
DSQ grading from 0 to 3
Change from Baseline at End of trial [3 month]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
A & U Tibbia College Karol Bagh

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dr. Richa Bhardwaj, M.D. (Ayu.), A & U Tibbia College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 3, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 29, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 5, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 11, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 11, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 5, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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