Population study of Urban, Rural and Semi-urban regions for the detection of Endovascular disease and prevalence of risk factors and Holistic Intervention Study - PURSE-HIS

Dr S Thanikachalam0 个研究点目标入组 8,025 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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•For modern medicine intervention:
•Inclusion: 1. Participants under the category of impaired glucose tolerance or impaired fasting glucose or diabetes.
•2. Blood pressure greater than 140/90 mmHg for non-diabetic participants and greater than130/85 for diabetic participants.
•3. Total cholesterol greater than 200mg/dl , Triglyceride greater than 150mg/dl , LDL-cholesterol greater than 100mg/dl
•For siddha medicine intervention:
•1. Fasting Plasma Glucose between 110 - 149 mg/dl, Post Prandial Plasma Glucose level between 200 - 299 mg/dl
•2.Total Cholesterol between 200 - 250 mg/dl, LDL-C between 130 - 159 mg/dl, HDL-C between 35 - 39 mg/dl, Triglycerides between 200 299 mg/dl
•3.Systolic Blood Pressure between 135 - 159 mmHg or Diastolic Blood pressure between 85 - 99 mmHg
•4.The subject must be newly detected with the presence of the risk factor or is previously detected and uses a single drug for the control of the same.
•5.The subject has no history, evidence or past history of presence of End organ damage involving the heart or brain.

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

发起方

Dr S Thanikachalam