Safety and Efficacy of Trikatu, an Ayurvedic Formulation, as an Add-On to Standard Care for Dyslipidemia
- Conditions
- Health Condition 1: E784- Other hyperlipidemia
- Registration Number
- CTRI/2023/04/051942
- Lead Sponsor
- Central Council for Research in Ayurvedic Sciences Ministry of Ayush Govt of India
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1. Diagnosis of moderate and high ASCVD risk dyslipidemia based on the ACC/AHA Guidelines, 2019 on the Primary Prevention of Cardiovascular Disease and indicated for statin therapy
2.Body Mass Index (BMI) >= 18.5 and < 34.9 kg/m².
3. Written informed consent provided prior to screening, after receiving and understanding the subject information.
4. Willingness to adhere to the treatment for a period of 12 weeks
1. Subjects on any lipid altering drug therapy other than statins
2. Patients of dyslipidemia with low ASCVD risk as per the ACC/AHA guidelines, 2019 and not indicated for statin therapy
3. Subject using or were using the following medications: systemic corticosteroids, cyclical or non-continuous hormone therapy (estrogen or testosterone). within 6 weeks prior to screening
4. Pregnant, lactating mother, Smoker, alcoholic
5. Severe liver and kidney disease, Myopathies
6. Any other condition, that as per the PI would jeopardize the study/ study outcomes
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in fasting serum LDL cholesterolTimepoint: [ Time Frame: 0, 12 weeks ]
- Secondary Outcome Measures
Name Time Method �Change in Adiponectin, ghrelin, apolipoprotein A1 and apolipoprotein B levels <br/ ><br>�Change in Hs-CRP, tumor necrosis factor-α (TNF-α) and interleukin-6 (IL-6) <br/ ><br>�Change in Resting blood pressure (measured in triplicate) <br/ ><br>Timepoint: [ Time Frame: 0, 6, 12 weeks ];�Change in fasting Total cholesterol <br/ ><br>�Changes in the Gut microbiota profile <br/ ><br>�Change in fasting HDL-cholesterol <br/ ><br>�Change in fasting Triglycerides <br/ ><br>�Change in fasting glucose, Insulin & HbA1CTimepoint: [ Time Frame: 0, 12 weeks ];�Improvement in homeostatic model assessment to quantify insulin resistance (HOMA-IR)Timepoint: [ Time Frame: 0, 12 weeks ];�Proportion of participants in the normal reference range (less than 200 mg/dl) for fasting T. cholesterolTimepoint: [ Time Frame: 0, 12 weeks ]