Clinical trial of plant sterol supplementation in hypercholesterolemia.
- Conditions
- Health Condition 1: E785- Hyperlipidemia, unspecified
- Registration Number
- CTRI/2021/08/035421
- Lead Sponsor
- Matrix fine Sciences Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 90
Male & Female subjects aged between 30 to 60
Dyslipidemia with any of the two parameters-
1. Subjects with- Total Cholesterol � 240 mg/dL, 2. Triglycerides � 200 mg/dL
3. Subjects with high LDL in the range of 130-220 mg/dL both inclusive
Subjects with or without comorbidities but stable on a prescription
Subjects with or without statin treatment
Subjects with any acute illness requiring immediate medical care.
Subjects who are contraindicated for statins/ phytosterols.
Known subject with CRF and at critical stage at screening.
Known subjects of hepatic failure/inflammation.
Patients with uncontrolled diabetes and hypertension.
Body mass index (BMI) >40 kg/m2.
Subject proving to be unfit from investigators discretion.
Pregnant and lactating women.
Patients who participated in any clinical trial within 30 days before enrollment into the study.
Subejcts in active infection phase for Covid 19.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Change in lipid profile: total cholesterol, triglycerides, LDL, VLDL, HDL <br/ ><br>2.Changes in Body Weight <br/ ><br>3.Changes in BMI, Hip waist ratio <br/ ><br>4.Changes in symptoms related to hypercholesterolemia <br/ ><br>Timepoint: Screening, baseline, day 30, day 60
- Secondary Outcome Measures
Name Time Method 1.Reduction in dose of statin <br/ ><br>2.Achievement of target levels of total cholesterol, serum triglycerides and LDL cholesterol, HDL <br/ ><br>3.Patient compliance <br/ ><br>4.Change in Quality of life of subjects <br/ ><br>Timepoint: Screening, baseline, day 30, day 60