A clinical trial to assess the Efficacy and safety of Ayurveda Formulation ‘Trikatu’ in Dyslipidemia

Phase 3

Recruiting

• Conditions: Hyperlipidemia, unspecified. Ayurveda Condition: MEDOROGAH,

• Registration Number: CTRI/2022/11/047322
• Lead Sponsor: Central Council for Research in Ayurvedic Sciences CCRAS

Brief Summary

Lipid disorders involving derangements in serum cholesterol, triglycerides, or both are commonly encountered in clinical practice and often have implications for cardiovascular risk and overall health. Dyslipidaemias are collectively among the most commonly detected lifestyle or chronic metabolic disorder. They are classically characterized by abnormal serum levels of cholesterol, triglycerides, or both, involving abnormal levels of related lipoprotein species1. The most common risk factor and cause for mortality and morbidity associated with dyslipidaemia is associated atherosclerotic cardiovascular disease (ASCVD). Dyslipidemias are an active and expanding area of research, with recent studies providing insight into their molecular basis and genetic origins, outlining their role in the development of atherosclerosis, and clarifying the ability of pharmacologic agents to ameliorate ASCVD risk in affected individuals. There is a strong pathophysiological association of raised LDL cholesterol with initiation and progression of coronary atherosclerosis and contemporary clinical evidence shows that lowering its levels can regress and stabilize atherosclerotic vascular disease. Treatment of dyslipidaemia is the most effective modifiable target for improving cardiovascular outcomes.

In India, only limited studies exist on epidemiology of cholesterol and other lipoprotein lipids on large samples in the last 20 years2,3. Studies from India have reported greater triglyceride levels in rural and urban populations associated with low HDL cholesterol levels4. The low HDL cholesterol and hypertriglyceridemia are metabolically interlinked and their combination has been termed as atherogenic dyslipidemia, which is also associated with increased levels of small-dense LDL particles and insulin resistance5.

The prevalence rates of various fasting dyslipidemia in the first phase of ICMR INDIAB study restricted to urban and rural populations in 4 states in India was hypercholesterolemia in 13.9%, high triglycerides in29.5%, low HDL cholesterol in 72.3% and high LDL cholesterol in11.8%. 79% men and women had abnormalities in at least one of the lipid parameters6. Focus on dyslipidemia management is urgently required in India to halt the rising tide of coronary heart disease.

When lifestyle interventions alone are not enough to correct dyslipidemia, or those who are determined to be at sufficient ASCVD risk, lipid modifying drugs are used after a clinician–patient overall discussion. In most patients, currently available lipid modifying drugs are effective in bringing the lipid levels to goal thereby reducing the risk of CV events7. The general approach to management is that in young adult patients (20 - 39 years) promoting a healthy lifestyle can suffice and improve dyslipidemia. Pharmacological therapy in this population is usually indicated in patients with LDL-C levels (starting from 160 mg/dL or higher than 100 mg/dL in high risk patients).

Dietary interventions appear to be a promising strategy for managing premature hyperlipidemia. In a trial, a probiotic formulation resulted in decreased LDL-C and improvements in triglyceridemia and HDL cholesterol (HDL-C) levels. Mechanisms that support the potential efficacy of the abovementioned interventions include the suppression of liver cholesterol synthesis, reduction of intestinal cholesterol absorption and production of conjugated linoleic acid in the gut8.  Expanding scientific evidence indicates that the gut microbiota mediates pathophysiological mechanisms that alter lipid metabolism and other related metabolic traits9.  Particularly, the intestinal microbiota has been recognized as a metabolically active endocrine organ of the human super-organism that can be a therapeutic target for hyperlipidemia and associated cardio-metabolic diseases10.

"Trikatu"-an Ayurvedic formulation comprising of a 1:1:1 ratio of dried fruits of *Piper nigrum, Piper longum* and dried rhizomes of *Zingiber officinale* is widely used in Ayurveda clinical practice. It is used since time immemorial and is also included in Ayurvedic Formulary of India and indicated in various  diseases  like, Arocaka (Tastelessness), Agnimandya (Digestive impairment), Amadosa (Products  of  impaired digestion  and  metabolism  /  consequences  of Ama), Gala  Roga (Diseases  of  throat), Pinasa (Chronic  rhinitis/sinusitis), Kustha (Diseases  of skin), Swasa (Dyspnoea/Asthma), Kasa (Cough), Tvakroga (Skin  disease), Gulma (Abdominal lump), Meha (Excessive flow of urine), Sthaulya (Obesity), Slipada (Filariasis)11. Clinical evidence from a study on Trikatu in dyslipidemia depicts statistically significant improvement in the parameters of lipid profile and obesity when administered for a period of 8 weeks12.

This study is planned with the objective to utilize the anti-dyslipidemic activity of Trikatu to effectively improve the lipid metabolism and to regulate the gut dysbiosis which is now considered a marker of impaired metabolism

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-21
• Last Update Posted: 2023-06-28

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 120

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 Index (BMI) ≥ 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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage Change in fasting plasma triglycerides	0, 12 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Central Ayurveda Research Institute, Kanakapura road, Bengaluru- 560109; 🇮🇳 Bangalore, KARNATAKA, India

Central Ayurveda Research Institute, Kanakapura road, Bengaluru- 560109

🇮🇳Bangalore, KARNATAKA, India

Dr Bhavya BM

Principal investigator

9741748242

drbhavya25@gmail.com