A clinical trial to study the effect of Shunthyadam Vati to prevent heart disease.
Phase 3
Recruiting
- Conditions
- Health Condition 1: I251- Atherosclerotic heart disease of native coronary arteryHealth Condition 2: I00-I99- Diseases of the circulatory systemHealth Condition 3: I10- Essential (primary) hypertensionHealth Condition 4: I10- Essential (primary) hypertensionHealth Condition 5: I30-I52- Other forms of heart disease
- Registration Number
- CTRI/2021/01/030275
- Lead Sponsor
- Dr Abhijit Dinkarrao Shekhar
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Patiens having signs and symptoms of Hridroga (cardiac diseases) having LDL levels greater than 130 mg/dl and total cholesterol greater than 160 mg/dl.
Exclusion Criteria
patients with a 10 year fatal CVD RISK SCORE <1% AT the screening visit; acute myocardial infarction; unstable angina; evidence of any acute metabolic, vascular, infective complications; abnormal LFT and RFT; pregnant and lactating mother; known history of hemorrhagic stroke; known history of positive HIV test; laboratory findings during screening period suggesting positive hepatitis B ,POSITIVE SERUM OR URINE PREGNANCY TEST, ALT or AST >3x ULN, TSH ULN ,TRIGLYCERIDES > 400 mg/dl: abnormal life threatening ECG pattern and any other chronic diseases.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Imrovement in clinical signs and symptoms of sbjective parameter according to book gradation and biochemical parameters <br/ ><br>For high risk patient reduction in Framingham Risk score for ASCVD by 20% <br/ ><br>For intermediate risk patient reduction in score by 10% will be expected outcomeTimepoint: 4 weeks
- Secondary Outcome Measures
Name Time Method â?¢To demonstrate relief from clinical signs and symptoms of Hridroga (Cardiac diseases) by Shunthyadam Vati in patients prone to risk factors like obesity, smoking, high Low density lipoprotein (LDL) cholesterol, low High density Lipoprotein (HDL) cholesterol ,uncontrolled hypertension (HTN)/ hypo tension, physical inactivity, uncontrolled diabetes mellitus (DM), under stressful circumstances. <br/ ><br>â?¢Evaluate the safety and tolerability of Shunthyadam Vati. <br/ ><br>Timepoint: 12 weeks