Effect of neem extract on diabetes mellitus

Phase 4

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

• Registration Number: CTRI/2018/12/016666
• Lead Sponsor: Dr G Srinivas

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Male and female subjects between 30-65 years and willing to give informed consent and comply with protocol related study procedures.

2. Fasting plasma glucose of 110-126 mg/dL.

3. Glycosylated haemoglobin (HbA1c) between 6.5 % and 8%.

4. Patients on stable dose of anti-diabetic treatment (metformin 1500-2500 mg/day) for the past 8 weeks prior to the screening.

5. Patients with endothelial dysfunction ââ?¬â?? (salbutamol challenge test) documented as decrease in RI index by <6%.

6. Subjects not on any investigational products in the past 6 months.

Exclusion Criteria

1. Subjects with abnormal hematological or biochemical parameters considered significant by investigator.

2. Uncontrolled diabetes(HbA1c > 8% and FBS > 210 mg/dl).

3. Uncontrolled hypertension ( SBP >180mmHg and DBP >100mmHg).

4. Serum Triglycerides >500mg/dl.

5. AST and ALT elevation >3 times upper limit of normal.

6. Serum creatinine more than 1.5 mg/dl.

7. On any other dietary or herbal supplements.

8. Any medical condition where physician feels participation in the study could be detrimental to subjects well being.

Study & Design

• Study Type: Interventional
• Study Design: Not specified