Efficacy and safety of the ayurvedic formulation 'Trikatu' as an add-on to standard care in dyslipidemia: Study protocol for a randomized, double-blind, placebo-controlled trial evaluating lipid parameters, and gut microbiota.
This paper describes a protocol for a randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of Trikatu (1000 mg twice daily) as an add-on to standard statin therapy on lipid parameters and gut microbiota in participants with moderate to high ASCVD risk dyslipidemia.
Key Findings
Methods
The trial is designed to enroll 170 participants with moderate to high ASCVD risk dyslipidemia across a single tertiary care center.
Participants are aged 25–60 years and meet dyslipidemia criteria as defined by the 2019 ACC/AHA Guidelines and are indicated for statin therapy.
The study is being conducted at AIIMS Bhubaneswar, a tertiary care center in India.
Participants are randomized in a 1:1 ratio to Trikatu or matching placebo groups (85 per arm).
The trial is registered with the Clinical Trial Registry of India (CTRI/2023/04/051942), registered on 25/04/2023.
Methods
The intervention consists of Trikatu at 1000 mg or matching placebo administered orally twice daily after food for 12 weeks, alongside standard statin therapy.
Trikatu is a classical Ayurvedic formulation traditionally known to enhance metabolism.
Standard statin therapy dose and intensity are prescribed as per guidelines.
The intervention duration is 12 weeks.
The trial design is randomized, double-blind, and placebo-controlled.
Methods
The primary outcome measure is the change in fasting serum LDL-C from baseline to 12 weeks.
LDL-C reduction was selected as the primary endpoint given that early and sustained LDL-C reduction offers significant preventive benefits for cardiovascular disease.
The proportion of participants achieving normal cholesterol levels (<200 mg/dL) will also be assessed as an additional efficacy measure.
Baseline and 12-week measurements will be compared between the Trikatu and placebo arms.
Methods
Secondary outcomes include a broad set of lipid, glycemic, inflammatory, metabolic, and hemodynamic markers, as well as gut microbiota changes.
Lipid secondary outcomes include total cholesterol, HDL-C, and triglycerides.
Glycemic markers include fasting glucose, HbA1c, insulin, and HOMA-IR.
Inflammatory and metabolic markers include hs-CRP, TNF-α, IL-6, adiponectin, ghrelin, ApoA1, and ApoB.
Resting blood pressure and gut microbiota composition are also secondary outcomes.
Drug compliance and adverse events will be recorded throughout the trial.
Background
The study protocol was developed in the context of alarmingly low long-term adherence to statin therapy in low- and middle-income countries.
Dyslipidemia is identified as a leading modifiable risk factor for cardiovascular disease (CVD).
Poor long-term adherence to statin therapy in low-resource settings is identified as limiting real-world impact of standard care.
The protocol frames Trikatu as a culturally acceptable and potentially safer adjunctive option to address this adherence gap.
The study aims to explore Trikatu's potential to augment cardiovascular risk reduction 'in a holistic and culturally acceptable manner.'
Methods
The study protocol includes assessment of gut microbiota changes and identification of microbial correlates associated with favorable lipid outcomes.
Gut microbiota assessment is included as both a secondary outcome and a mechanistic investigation.
The study aims to 'identify microbial correlates associated with favorable lipid outcomes.'
This represents a novel component of evaluating an Ayurvedic formulation in the context of dyslipidemia management.
Changes in gut microbiota will be assessed in response to the Trikatu intervention compared to placebo.
What This Means
This paper describes the design and protocol for a clinical trial—not yet completed results—testing whether an ancient Ayurvedic herbal combination called Trikatu can help lower cholesterol when added to standard statin medication. Trikatu is a blend of three spices (black pepper, long pepper, and ginger) that has traditionally been used in Indian medicine to improve metabolism. The trial will enroll 170 adults in India with high cholesterol who are already at moderate to high risk of heart disease, randomly assigning them to take either Trikatu (1000 mg twice daily) or a placebo pill alongside their regular statin medication for 12 weeks. The main question is whether LDL cholesterol (the 'bad' cholesterol) drops more in those taking Trikatu compared to placebo.
Beyond cholesterol, the trial will also measure blood sugar markers, inflammation markers, blood pressure, and—notably—the composition of gut bacteria before and after treatment. This gut microbiota component is designed to explore whether changes in the balance of intestinal bacteria might help explain any cholesterol-lowering effects observed. The researchers also plan to track whether participants actually take their medications as prescribed and whether any side effects occur.
This research suggests that if Trikatu proves both effective and safe, it could serve as a complementary treatment option for people with high cholesterol, particularly in lower-income countries where many patients stop taking statins over time due to cost, side effects, or cultural preferences. The study is important because it applies rigorous scientific methods (randomized, double-blind, placebo-controlled design) to evaluate a traditional remedy, potentially bridging conventional and traditional medicine approaches to heart disease prevention. However, it is important to note that this paper only describes the study protocol—no results are yet available.
Khanduri S, Jameela S, Sahu S, Devi S, Rao B, Ratha K, et al.. (2026). Efficacy and safety of the ayurvedic formulation 'Trikatu' as an add-on to standard care in dyslipidemia: Study protocol for a randomized, double-blind, placebo-controlled trial evaluating lipid parameters, and gut microbiota.. PloS one. https://doi.org/10.1371/journal.pone.0348058