CTRI/2021/08/035421
Completed
Phase 2
Randomized, placebo controlled clinical trial to evaluate the efficacy and safety of Phytolite plant sterol (95%) supplementation in the management of hypercholesterolemia. - Nil
Matrix fine Sciences Pvt Ltd0 sites90 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Matrix fine Sciences Pvt Ltd
- Enrollment
- 90
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male \& Female subjects aged between 30 to 60
- •Dyslipidemia with any of the two parameters\-
- •1\. Subjects with\- Total Cholesterol ââ?°Â¥ 240 mg/dL, 2\. Triglycerides ââ?°Â¥ 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
Exclusion Criteria
- •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\.
Outcomes
Primary Outcomes
Not specified
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