Clinical trial NCT05451147: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: A & U Tibbia College Karol Bagh
Sponsor class: OTHER
First posted: 2022-07-11
Enrollment: 48
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, Controlled, Parallel Group Trial.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: OBJECTIVE PARAMETERS
timeFrame: Change from Baseline at End of trial [3 month]
measure: OBJECTIVE PARAMETERS
timeFrame: Change from Baseline at End of trial [3 month]
measure: OBJECTIVE PARAMETERS
timeFrame: Change from Baseline at End of trial [3 month]
Secondary outcomes:
measure: SUBJECTIVE PARAMETERS
timeFrame: Change from Baseline at End of trial [3 month]
measure: SUBJECTIVE PARAMETERS
timeFrame: Change from Baseline at End of trial [3 month]
measure: SUBJECTIVE PARAMETERS
timeFrame: Change from Baseline at End of trial [3 month]
measure: SUBJECTIVE PARAMETERS
timeFrame: Change from Baseline at End of trial [3 month]
measure: SUBJECTIVE PARAMETERS
timeFrame: Change from Baseline at End of trial [3 month]
measure: SUBJECTIVE PARAMETERS
timeFrame: Change from Baseline at End of trial [3 month]
measure: SUBJECTIVE PARAMETERS
timeFrame: Change from Baseline at End of trial [3 month]
measure: SUBJECTIVE PARAMETERS
timeFrame: Change from Baseline at End of trial [3 month]
measure: SUBJECTIVE PARAMETERS
timeFrame: Change from Baseline at End of trial [3 month]
measure: SUBJECTIVE PARAMETERS
timeFrame: Change from Baseline at End of trial [3 month]
measure: SUBJECTIVE PARAMETERS
timeFrame: Change from Baseline at End of trial [3 month]
Other outcomes:
Locations:
city: Delhi
country: India
facility: A and U Tibbia College
Study officials:
affiliation: A & U Tibbia College
name: Dr. Richa Bhardwaj, M.D. (Ayu.)
role: PRINCIPAL_INVESTIGATOR
References: