Effect of neem capsule on metabolic syndrome

Phase 4

• Conditions: Health Condition 1: E889- Metabolic disorder, unspecified

• Registration Number: CTRI/2019/03/018034
• 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.Subjects having endothelial dysfunction defined as � 6% change in reflection index (RI) on post salbutamol challenge test.

3. Subjects who comply with ââ?¬Å?The International Diabetes Federationââ?¬? guidelines dated 2006.

4. 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 hypertension (SBP >180mmHg and DBP >100mmHg).

3. Serum Triglycerides >500mg/dl.

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

5. Serum creatinine more than 1.5 mg/dl.

6. On any other dietary or herbal supplements.

7. History of malignancy or stroke.

8. Smoking, chronic alcoholism.

9. 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

Primary Outcome Measures

Name	Time	Method
1.Change in lipid profile with 12 weeks therapy. <br/ ><br>2.Reduction in FBS by at least 10mg/dl <br/ ><br> <br/ ><br>Timepoint: Baseline to 12 weeks of therapy <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
1.Change in endothelial dysfunction as assessed by more than 6% change in reflection index <br/ ><br>2. Change in endothelial function biomarkers, nitric oxide (NO), glutathione (GSH), Malondialdehyde (MDA), high sensitivity C-reactive protein(hsCRP), HbA1c, platelet aggregation and lipid profile <br/ ><br>3. To evaluate change inHOMA-IR and proinflammatory cytokines- IL6, TNF alpha <br/ ><br>4. Safety and tolerability assessment of the test medications. <br/ ><br>Timepoint: Baseline to 12 weeks of therapy