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Clinical Trials/CTRI/2021/08/035421
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.

Registry
who.int
Start Date
TBD
End Date
December 29, 2021
Last Updated
3 years ago
Study Type
Interventional

Investigators

Sponsor
Matrix fine Sciences Pvt Ltd

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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