Currently submitted to: JMIR Research Protocols
Date Submitted: Nov 17, 2025
Open Peer Review Period: Nov 28, 2025 - Jan 23, 2026
(closed for review but you can still tweet)
NOTE: This is an unreviewed Preprint
Warning: This is a unreviewed preprint (What is a preprint?). Readers are warned that the document has not been peer-reviewed by expert/patient reviewers or an academic editor, may contain misleading claims, and is likely to undergo changes before final publication, if accepted, or may have been rejected/withdrawn (a note "no longer under consideration" will appear above).
Peer review me: Readers with interest and expertise are encouraged to sign up as peer-reviewer, if the paper is within an open peer-review period (in this case, a "Peer Review Me" button to sign up as reviewer is displayed above). All preprints currently open for review are listed here. Outside of the formal open peer-review period we encourage you to tweet about the preprint.
Citation: Please cite this preprint only for review purposes or for grant applications and CVs (if you are the author).
Final version: If our system detects a final peer-reviewed "version of record" (VoR) published in any journal, a link to that VoR will appear below. Readers are then encourage to cite the VoR instead of this preprint.
Settings: If you are the author, you can login and change the preprint display settings, but the preprint URL/DOI is supposed to be stable and citable, so it should not be removed once posted.
Submit: To post your own preprint, simply submit to any JMIR journal, and choose the appropriate settings to expose your submitted version as preprint.
Warning: This is an author submission that is not peer-reviewed or edited.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
Request queued. Please wait while the file is being generated. It may take some time.
Copyright
© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.