To see the effect of two medicines namely tryushnadi gutika and mustadi kashaya in the disease diabetes

Phase 2

• Conditions: Health Condition 1: E119- Type 2 diabetes mellitus without complications

• Registration Number: CTRI/2020/03/024406
• Lead Sponsor: Ayurvedic and Unani Tibbia College

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Patients of either sex aged between 20 to 65 years.

If yes in any two of the four:

Blood sugar â??fasting > 126 and <= 250 mg/dl.

PP > 200 mg/dl and <=350 mg/dl.

Glycosylated Haemoglobin (HbA1c) > 6.5% and < 10%

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-D)}.

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.

Diabetes Mellitus >2 years and <10 years.

Exclusion Criteria

Age below 20 and above 65yrs.

Subject of Type-I DM (insulin dependent DM) or Type-II DM on insulin/OHAâ??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 min. 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).

Diabetes Mellitus <2 years and >10 years.

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified