Currently accepted at: JMIR Research Protocols
Date Submitted: Nov 17, 2025
Open Peer Review Period: Nov 28, 2025 - Jan 23, 2026
Date Accepted: Sep 9, 2026
(closed for review but you can still tweet)
This paper has been accepted and is currently in production.
It will appear shortly on 10.2196/87567
The final accepted version (not copyedited yet) is in this tab.
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Efficacy and Safety of Ayurveda Formulation ‘Trikatu’ in Dyslipidemia: A Study Protocol for a Prospective Randomized Double Blind Placebo Controlled Trial
ABSTRACT
Background:
Dyslipidemia is a prevalent lifestyle and metabolic disorder that poses a significant risk for cardiovascular diseases. From the Ayurvedic standpoint, dyslipidemia may be understood as a disorder of fat metabolism. Trikatu, a classical Ayurvedic formulation is scientifically recognized for its role in modulating metabolic processes and enhancing bioavailability. This study was undertaken to assess its role on lipid parameters and markers of metabolism.
Objective:
To assess the efficacy and safety of Ayurvedic Formulation “Trikatu” for improving lipid parameters in dyslipidemia and to assess the changes in Gut Microbiota Correlates
Methods:
This study is a prospective, single-centre, randomized, double-blind, placebo-controlled clinical trial involving 120 participants aged 30–60 years with dyslipidemia, including borderline cases with low ASCVD risk and BMI between 18.5 and 29.9 kg/m². Participants will be randomized in a 1:1 ratio to receive either Trikatu (1000 mg) or a matching placebo, administered orally twice daily after food for 12 weeks, along with standardized dietary and lifestyle guidance. A follow-up assessment will be conducted 28 days post-intervention without medication. The primary outcome is the percentage change in fasting plasma triglycerides at 12 weeks. Secondary outcomes include improvements in total cholesterol, HDL, LDL, apolipoproteins, adiponectin, leptin, glycemic and inflammatory markers, gut microbiota profile, blood pressure, insulin resistance (HOMA-IR), and the proportion of participants achieving lipid targets. Drug compliance and any adverse events or drug reactions will be systematically documented.
Results:
The screening and recruitment process for this trial started on 29.12.2022. The trial is completed, but data analysis work is not yet initiated.
Conclusions:
The early intervention in dyslipidemia—especially in borderline cases with low ASCVD risk—is a sustainable strategy to curb the epidemic. Clinical Trial: Clinical Trial Registry of India (CTRI/2022/11/047322) Registered on 15/11/2022.
Citation
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Copyright
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