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临床试验/CTRI/2021/08/035421
CTRI/2021/08/035421已完成2 期

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 个研究点目标入组 90 人开始时间: 待定最近更新:

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
90

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

入选标准

  • 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

排除标准

  • 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.

研究者

发起方
Matrix fine Sciences Pvt Ltd

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