A clinical trial to assess the Efficacy and safety of Ayurveda Formulation â??Trikatuâ?? in Dyslipidemia
Phase 3
- Conditions
- Health Condition 1: E785- Hyperlipidemia, unspecified
- Registration Number
- CTRI/2022/11/047322
- Lead Sponsor
- Central Council for Research in Ayurvedic Sciences CCRAS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1.Participants of any gender in the age group 30-60 years
2.Diagnosis of primary dyslipidemia (Total Cholesterol in the range of >200 <239 mg/dl, LDL-C > 100 <159 mg/dl.
3.Participants at low risk of ASCVD disease ( <5% 10 year risk) as assessed through ASCVD calculator
4.Body Mass Index (BMI) >= 18.5 and < 29.9 kg/m².
5.Written informed consent provided prior to screening, after receiving and understanding the subject information.
6.Willingness to adhere to the treatment for a period of 3 months
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage Change in fasting plasma triglyceridesTimepoint: 0, 12 weeks
- Secondary Outcome Measures
Name Time Method 1.The proportion of participants in the normal reference range (less than 200 mg/dl) for fasting T. cholesterol <br/ ><br>2.Improvement in fasting HDL-cholesterol <br/ ><br>3.Improvement in fasting LDL-cholesterol <br/ ><br>4.Improvement in apolipoprotein A1 and apolipoprotein B <br/ ><br>5.Changes in the Gut microbiota profile <br/ ><br>6. Improvement in fasting adiponectin and leptin <br/ ><br>7.Improvement in Hs-CRP, tumor necrosis factor-α (TNF-α), and interleukin-6 (IL-6) <br/ ><br>8.Improvement in Resting blood pressure (measured in triplicate) <br/ ><br>9.Improvement in fasting glucose & HbA1C <br/ ><br>10.Improvement in fasting insulin <br/ ><br>11.Improvement in homeostatic model assessment to quantify insulin resistance (HOMA-IR) <br/ ><br>12.Drug compliance (elicited at each visit, in a structured compliance reporting form) <br/ ><br>13.Reported AE/ADR (Participant reported AE/ADR recorded in structured formats) <br/ ><br>Timepoint: 0, 12 weeks