FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/04/051942 [Registered on: 25/04/2023] Trial Registered Prospectively
Last Modified On: 02/07/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Safety and Efficacy of Trikatu, an Ayurvedic Formulation, as an Add-On to Standard Care for Dyslipidemia 
Scientific Title of Study   Efficacy and safety of Ayurveda Formulation ‘Trikatu’ as add-on to standard care in Dyslipidemia- A Randomized Controlled Trial  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR SUCHANDA SAHU 
Designation  Additional Professor 
Affiliation  AIIMS, Bhubaneswar 
Address  Department of Biochemistry, AIIMS, Sijua, Bhubaneswar

Khordha
ORISSA
751019
India 
Phone  9438884031  
Fax    
Email  biochem_suchanda@aiimsbhubaneswar.edu.in  
 
Details of Contact Person
Scientific Query  
Name  DR SUCHANDA SAHU 
Designation  Additional Professor 
Affiliation  AIIMS, Bhubaneswar 
Address  Department of Biochemistry, AIIMS, Sijua, Bhubaneswar

Khordha
ORISSA
751019
India 
Phone  9438884031  
Fax    
Email  biochem_suchanda@aiimsbhubaneswar.edu.in  
 
Details of Contact Person
Public Query  
Name  DR KSHIROD KUMAR RATHA 
Designation  Research Officer (Ayurveda) 
Affiliation  Central Ayurveda Research Institute,CCRAS, Bhubaneswar 
Address  Central Ayurveda Research Institute, Bhubaneswar, Odisha

Khordha
ORISSA
751029
India 
Phone  9874612213  
Fax    
Email  drkkratha@gmail.com  
 
Source of Monetary or Material Support  
Central Council for Research in Ayurvedic Sciences, Ministry of Ayush, Govt. of India, New Delhi 
 
Primary Sponsor  
Name  Central Council for Research in Ayurvedic Sciences Ministry of Ayush Govt of India 
Address  Central Council for Research in Ayurvedic Sciences, Ministry of Ayush, Govt. of India, 61-65, Institutional Area, Opposite “D” Block, Janakpuri, New Delhi - 110058  
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR SUCHANDA SAHU  AIIMS, BHUBANESWAR  Room No. 135 Department of Biochemistry, Academic Block, AIIMS, Sijua, Bhubaneswar
Khordha
ORISSA 		 9438884031

biochem_suchanda@aiimsbhubaneswar.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTEE,AIIMS, BHUBANESWAR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E784||Other hyperlipidemia. Ayurveda Condition: MEDOROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugOther than Classical(1) Medicine Name: PLACEBO OF TRIKATU, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 1000(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 12 Weeks, anupAna/sahapAna: Yes(details: -WATER), Additional Information: - TO BE TAKEN ONE HOUR AFTER FOOD
2Intervention ArmDrugClassical(1) Medicine Name: TRIKATU, Reference: The Ayurvedic Pharmacopoeia of India, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1000(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 12 Weeks, anupAna/sahapAna: Yes(details: -WATER), Additional Information: -TO BE TAKEN 1 HR AFTER MEAL
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  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 < 34.9 kg/m².
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
 
 
ExclusionCriteria 
Details  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
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Change in fasting serum LDL cholesterol   [ Time Frame: 0, 12 weeks ] 
 
Secondary Outcome  
Outcome  TimePoints 
• Change in fasting Total cholesterol
• Changes in the Gut microbiota profile
• Change in fasting HDL-cholesterol
• Change in fasting Triglycerides
• Change in fasting glucose, Insulin & HbA1C  		 [ Time Frame: 0, 12 weeks ] 
• Change in Adiponectin, ghrelin, apolipoprotein A1 and apolipoprotein B levels
• Change in Hs-CRP, tumor necrosis factor-α (TNF-α) and interleukin-6 (IL-6)
• Change in Resting blood pressure (measured in triplicate)
 		 [ Time Frame: 0, 6, 12 weeks ] 
• Improvement in homeostatic model assessment to quantify insulin resistance (HOMA-IR)   [ Time Frame: 0, 12 weeks ] 
• Proportion of participants in the normal reference range (less than 200 mg/dl) for fasting T. cholesterol   [ Time Frame: 0, 12 weeks ] 
 
Target Sample Size   Total Sample Size="170"
Sample Size from India="170" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   28/04/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Dyslipidemia, a common disorder characterized by abnormal levels of cholesterol, triglycerides, or both, and its association with cardiovascular risk and overall health. Dyslipidemia is an active area of research, and recent studies provide insight into its molecular basis and genetic origins, role in the development of atherosclerosis, and ability of pharmacological agents to ameliorate cardiovascular disease risk. In India, dyslipidemia is prevalent, and the focus on dyslipidemia management is urgently required to halt the rising tide of coronary heart disease. Lifestyle interventions and pharmacological therapy are the mainstay of management, but dietary interventions and Ayurvedic formulations like Trikatu can also help manage dyslipidemia. This study aims to assess the efficacy and safety of Trikatu for improving lipid parameters and regulating gut dysbiosis, which is now considered a marker of impaired metabolism. The study will be conducted by AIIMS, Bhubaneswar, and Central Ayurveda Research Institute, Bhubaneswar, with investigations carried out at Biochemistry Department and Central laboratory, AIIMS, Bhubaneswar. 
Close