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

• Status: Completed
• Trial end date: 2019-04-30
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: A & U Tibbia College Karol Bagh
• Treatments: Metformin

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.