Health Condition 1: E785- Hyperlipidemia, unspecified
Conditions
Interventions
None listed
Sponsors
Central Council for Research in Ayurvedic Sciences CCRAS
Eligibility
Inclusion criteria
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 >200 100 3. Participants at low risk of ASCVD disease ( 4. Body Mass Index (BMI) >= 18.5 and 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
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage Change in fasting plasma triglyceridesTimepoint: 0, 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The proportion of participants in the normal reference range (less than 200 mg/dl) for fasting T. cholesterol 2. Improvement in fasting HDL-cholesterol 3. Improvement in fasting LDL-cholesterol 4. Improvement in apolipoprotein A1 and apolipoprotein B 5. Changes in the Gut microbiota profile 6. Improvement in fasting adiponectin and leptin 7. Improvement in Hs-CRP, tumor necrosis factor-α (TNF-α), and interleukin-6 (IL-6) 8. Improvement in Resting blood pressure (measured in triplicate) 9. Improvement in fasting glucose & HbA1C 10. Improvement in fasting insulin 11. Improvement in homeostatic model assessment to quantify insulin resistance (HOMA-IR) 12. Drug compliance (elicited at each visit, in a structured compliance reporting form) 13. Reported AE/ADR (Participant reported AE/ADR recorded in structured formats) Timepoint: 0, 12 weeks | — |
Countries
India
Contacts
Public ContactDr Bhavya BM
Central Ayurveda Research Institute, Bengaluru
Outcome results
None listed