An open-label, single-arm, non randomizedobservational study to evaluate the safety, efficacy andtolerability of VASOCLEAR syrup in patients withcardio vascular problems

RATHNA BIOTECK PvtLtd0 个研究点目标入组 40 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•Subject of either sex aged between 18 â?? 65 years
•Male and female outpatients between 18-75 Years of age.
•Patients having i. LDL cholesterol >130mg/dl ,
•Serum triglycerides > or equal to 150mg/dl and < or equal to 500mg/dl
•Serum creatinine of <3.0mg/dl.
•Willingness and able to give informed consent and comply with requirements for participation in the study.

•Subject who is pregnant or Lactating
•Any of the following is regarded as a criterion for exclusion from the study:
•History of serious adverse effect or hypersensitivity reactions to the medication used in the treatment of subjects in any arm of the study.
•Pregnant women and breast feeding
•History of malignancy
•Active liver disease or hepatic dysfunction as defined by elevations of AST or ALT greater than1.5times ULN.
•Uncontrolled serum CK greater than3 times ULN
•Serum creatinine greater than 2.5mg/dl
•Participation in another investigational drug trial within the previous 4 weeks diabetic foot ulcers in the last 30 days

发起方

RATHNA BIOTECK PvtLtd