Effect of neem in prediabetic subjects

Phase 4

Completed

• Conditions: Health Condition 1: R688- Other general symptoms and signs

• Registration Number: CTRI/2020/03/023950
• Lead Sponsor: Dr K Sireesha

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-01-21
• Last Update Posted: 13 November 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

1.Male and female subjects between 25-55 years will be recruited as per the American Diabetes Association (ADA) definition for prediabetes condition.

2. Subjects with BMI = 25 kg/m2.

3.Subjects with impaired fasting glucose defined as fasting blood glucose of 100-125 mg/dl.

4.Subjects with impaired oral glucose tolerance test (OGTT) defined as 2 hours blood glucose during 75-grams OGTT levels between 140-199 mg/dL.

5.Glycosylated hemoglobin (HbA1c) = 5.7% to < 6.4%

6.Subjects with endothelial dysfunction – (salbutamol challenge test) documented as decrease in RI index by <6%.

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

Exclusion Criteria

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

2. Subjects with diagnosis of diabetes.

3. Uncontrolled hypertension (SBP >140mmHg and DBP >90mmHg).

4. Serum Triglycerides >250mg/dL and HDL < 35 mg/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. Diagnosis of Cardiovascular disorders, CNS disorders, diagnosis of neoplasia/malignancy, autoimmune disorders, major depression and other psychiatric conditions or any current degenerative, inflammatory and infectious disease that may affect outcome of the study.

9. Pregnant women or women anticipating pregnancy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified