A clinical trial to assess the Efficacy and safety of Ayurveda Formulation â??Trikatuâ?? in Dyslipidemia

INTERVENTION: CONDITION: Health Condition 1: E785‐ Hyperlipidemia, unspecified PRIMARY OUTCOME: Percentage Change in fasting plasma triglyceridesTimepoint: 0, 12 weeks SECONDARY OUTCOME: 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 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 Inde X(BMI) â?¥ 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