A clinical trial to assess the Efficacy and safety of liposomal Curcumin in subjects with metabolic syndrome

Not Applicable

• Conditions: Health Condition 1: null- Metabolic syndrome

• Registration Number: CTRI/2017/06/008903
• Lead Sponsor: CureSupport

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

Inclusion Criteria

1. 18 years of age and above

2. Metabolic abnormalities with or without alcohol consumption and/or smoking

3. Diagnosis of MetS ie. the presence of three or more criteria of the modified National Cholesterol Education Programs Adult Treatment Panel III ( NCEP ATP III):

3.1 Waist circumference 90 cm in men and 80 cm in women

3.2 Hypertriglyceridemia >= 150 mg/dl

3.3 High density lipoprotein (HDL) cholesterol 40 mg/dl in males and 50 mg/dl in females

3.4 Blood pressure >= 130/85 mm Hg

3.5 Fasting plasma glucose >= 110 mg/dl

4.0 Patients willing to provide written informed consent

Exclusion Criteria

1. Pregnancy or breastfeeding,

2. lack of compliance with the study medication (defined as not using the medication for >1 week),

3. Participation in a concomitant trial,

4. Hypersensitivity to the study medication,

5. Presence of malignancies

6. Impossibility to give informed consent.

7. Intake of drugs or dietary supplements

8. Previous illnesses such as heart attack, cancer or dementia

9. Addiction illness

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Inflammatory marker C-reactive protein (CRP) at baseline and 6 weeks.Timepoint: Inflammatory marker C-reactive protein (CRP) at baseline and 6 weeks.

Secondary Outcome Measures

Name	Time	Method
Plasma tumor necrosis factor alpha at baseline and 6 weeks <br/ ><br>Plasma interleukine 6 at Baseline and 6 weeks <br/ ><br>Body weight, anthropometric assessments, <br/ ><br>Biochemistry and lipis profile assessment baseline and 6 weeks <br/ ><br>Incidence rates of adverse event and changes in vital signs <br/ ><br>Blood Hematology assessment <br/ ><br>Quality of life using SF-36 questionnaireTimepoint: Baseline (Day 0) and Day 42