跳至主要内容
临床试验/CTRI/2024/05/067325
CTRI/2024/05/067325尚未招募Unknown

Evaluation of safety and effectiveness of biozen syrup in the management of hyperlipidemia- An open-label study. - NI

Aathithya herbals0 个研究点目标入组 0 人开始时间: 待定最近更新:

试验速览

阶段
Unknown
状态
尚未招募
发起方

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

  • 1. Male or female with age of 20-60 years.
  • 2. BMI between 25 to 40 kg/m2.
  • 3. Subjects with elevated lipid profile parameters.
  • (i) Total Cholesterol more than 200mg/dl (or)
  • (ii) Triglycerides more than 150mg/dl (or)
  • (iii) LDL more than 130mg/dl
  • 4. Willing to give written informed consent.

排除标准

  • 1. Subjects with abnormal hematologic function (Hemoglobin 8gm/dl, WBC count
  • 3000/mm3, platelet count 100,000/mm3).
  • 2. Any concomitant serious disorders of the liver ,kidneys , heart, lungs and other organs
  • 3. Evidence of psychiatric disorder, antagonistic personality, poor motivation, emotional or
  • intellectual problems likely to limit the validity of consent to participate in the study or
  • limit the ability to comply with protocol requirements.
  • 4. Abnormally elevated liver enzymes (ALT and/or AST more than 2 times ULN).
  • 5. Elevated creatinine phosphokinase (CPK) (more than 3 times ULN).
  • 6. Gravid women and lactating mother.
  • 7. Heavy smoker, Chronic alcoholic, or drug abuse subjects
  • 8. Known cases of malignancy, HIV infection, AIDS, etc.
  • 9. Subject who participated in any other clinical investigation using an experimental drug in
  • the past 3 months.
  • 10. Participants are not willing to sign the ICF and to attend treatment schedule regularly.

研究者

发起方
Aathithya herbals

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