AzTrials
AzTrials

Diabetes Mellitus, Type 2Phase 3NCT05451147

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

A Phase 3 study testing Chhinnavahni Kashaya Vati along with Agnimantha Kwatha and Metformin Hydrochloride in people with Diabetes Mellitus, Type 2, run by A & U Tibbia College Karol Bagh at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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 Read more about this study

Who is it for?
Ages 20 to 60 years
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Chhinnavahni Kashaya Vati along with Agnimantha Kwatha and Metformin Hydrochloride
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteIndia
Study dates
3 Sep 2018to 30 Apr 2019
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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).
Show all 9Show fewer
  • 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.

Who cannot join

  • 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).
Show all 14Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

India1 site

  • A and U Tibbia College

    Delhi, 110005

Other trials in India

About this study

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)

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

Read the 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.

Being tested
Chhinnavahni Kashaya Vati along with Agnimantha Kwatha, Metformin Hydrochloride
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Chhinnavahni Kashaya Vati along with Agnimantha KwathaDrug

    Also called Chhinnavahni Kashaya Vati, 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

  • Metformin HydrochlorideDrug

    Also called Metformin

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

Study groups in NCT05451147
Study groupRoleWhat they receive
Group AExperimentalDRUG: 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
Receives: Drug: Chhinnavahni Kashaya Vati along with Agnimantha Kwatha
GROUP BActive comparatorDRUG: Metformin FORM: Tablet DOSE: 500mg BID/TDS, Before Meals MODE OF ADMINISTRATION: Oral ANUPAAN:: Plain Water DURATION 3 Months
Receives: Drug: Metformin Hydrochloride

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. OBJECTIVE PARAMETERS

    1. Blood sugar fasting in Milligrams per decilitre

    Measured: Change from Baseline at End of trial [3 month]

  2. OBJECTIVE PARAMETERS

    Blood sugar post prandial Milligrams per decilitre

    Measured: Change from Baseline at End of trial [3 month]

  3. OBJECTIVE PARAMETERS

    Glycosylated Haemoglobin (HbA1c in %)

    Measured: Change from Baseline at End of trial [3 month]

Secondary outcomes (11)

  1. SUBJECTIVE PARAMETERS

    Polyurea (excessive urine) grading from 0 to 3

    Measured: Change from Baseline at End of trial [3 month]

  2. SUBJECTIVE PARAMETERS

    Unclear / turbid urine grading from 0 to 3

    Measured: Change from Baseline at End of trial [3 month]

  3. SUBJECTIVE PARAMETERS

    Polyphagia( excessive hunger) grading from 0 to 3

    Measured: Change from Baseline at End of trial [3 month]

  4. SUBJECTIVE PARAMETERS

    Polydipsia (excessive thirst) grading from 0 to 3

    Measured: Change from Baseline at End of trial [3 month]

  5. SUBJECTIVE PARAMETERS

    Exhaustion / tiredness grading from 0 to 3

    Measured: Change from Baseline at End of trial [3 month]

  6. SUBJECTIVE PARAMETERS

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

    Measured: Change from Baseline at End of trial [3 month]

  7. SUBJECTIVE PARAMETERS

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

    Measured: Change from Baseline at End of trial [3 month]

  8. SUBJECTIVE PARAMETERS

    Constipation grading from 0 to 3

    Measured: Change from Baseline at End of trial [3 month]

  9. SUBJECTIVE PARAMETERS

    Excessive Sweating grading from 0 to 3

    Measured: Change from Baseline at End of trial [3 month]

  10. SUBJECTIVE PARAMETERS

    Excessive Sleeping grading from 0 to 3

    Measured: Change from Baseline at End of trial [3 month]

  11. SUBJECTIVE PARAMETERS

    DSQ grading from 0 to 3

    Measured: Change from Baseline at End of trial [3 month]

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jul 2022
  2. Study start3 Sep 2018
  3. Primary completion30 Apr 2019
  4. Study completion30 Apr 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized, Controlled, Parallel Group Trial.
Masking
None (open label)
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05451147
Sponsor's protocol ID
N.F.5(283)/2013-CO
Status last verified
Jul 2022
First submitted
29 May 2022
Last updated
11 Jul 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Chhinnavahni Kashaya Vati along with Agnimantha Kwatha and Metformin Hydrochloride in people with Diabetes Mellitus, Type 2, run by A & U Tibbia College Karol Bagh at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

OBJECTIVE PARAMETERS (time frame: Change from Baseline at End of trial [3 month]). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05451147.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in