Safety and Efficacy of Trikatu, an Ayurvedic Formulation, as an Add-On to Standard Care for Dyslipidemia

Efficacy and safety of Ayurveda Formulation â??Trikatuâ?? as add-on to standard care in Dyslipidemia- A Randomized Controlled Trial

Status

Recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/04/051942

Enrollment

170

Registered

2023-04-25

Start date

Unknown

Completion date

Unknown

Last updated

2023-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E784- Other hyperlipidemia

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 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 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Change in fasting serum LDL cholesterolTimepoint: [ Time Frame: 0, 12 weeks ]	—

Secondary

Measure	Time frame
â?¢ Change in Adiponectin, ghrelin, apolipoprotein A1 and apolipoprotein B levels â?¢ Change in Hs-CRP, tumor necrosis factor-Î± (TNF-Î±) and interleukin-6 (IL-6) â?¢ Change in Resting blood pressure (measured in triplicate) Timepoint: [ Time Frame: 0, 6, 12 weeks ];â?¢ Change in fasting Total cholesterol â?¢ Changes in the Gut microbiota profile â?¢ Change in fasting HDL-cholesterol â?¢ Change in fasting Triglycerides â?¢ Change in fasting glucose, Insulin & HbA1CTimepoint: [ Time Frame: 0, 12 weeks ];â?¢ Improvement in homeostatic model assessment to quantify insulin resistance (HOMA-IR)Timepoint: [ Time Frame: 0, 12 weeks ];â?¢ Proportion of participants in the normal reference range (less than 200 mg/dl) for fasting T. cholesterolTimepoint: [ Time Frame: 0, 12 weeks ]	—

Measure

Time frame

â?¢ Change in Adiponectin, ghrelin, apolipoprotein A1 and apolipoprotein B levels â?¢ Change in Hs-CRP, tumor necrosis factor-Î± (TNF-Î±) and interleukin-6 (IL-6) â?¢ Change in Resting blood pressure (measured in triplicate) Timepoint: [ Time Frame: 0, 6, 12 weeks ];â?¢ Change in fasting Total cholesterol â?¢ Changes in the Gut microbiota profile â?¢ Change in fasting HDL-cholesterol â?¢ Change in fasting Triglycerides â?¢ Change in fasting glucose, Insulin & HbA1CTimepoint: [ Time Frame: 0, 12 weeks ];â?¢ Improvement in homeostatic model assessment to quantify insulin resistance (HOMA-IR)Timepoint: [ Time Frame: 0, 12 weeks ];â?¢ Proportion of participants in the normal reference range (less than 200 mg/dl) for fasting T. cholesterolTimepoint: [ Time Frame: 0, 12 weeks ]

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Countries

India

Contacts

Public ContactDR KSHIROD KUMAR RATHA

AIIMS, Bhubaneswar

biochem_suchanda@aiimsbhubaneswar.edu.in9438884031

Outcome results