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CTRI Number  CTRI/2025/05/087052 [Registered on: 16/05/2025] Trial Registered Prospectively
Last Modified On: 08/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   "Checking the Benefits of Bruhtyadi Vati in People with High Cholesterol (Dyslipidemia)" 
Scientific Title of Study   Randomised Open Controlled Clinical Study to evaluate the effect of Bruhatyadi Vati in management of Medodushti with special reference to Dyslipidema 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nileshkumar Samarjit Tiwari 
Designation  PhD Scholar 
Affiliation  R.A Podar Medical College(Ayu), Mumbai 
Address  Department- Kayachikitsa First Floor, Casaulty Building R.A Podar Medical College(Ayu), Dr. A.B Road,Worli, Mumbai

Mumbai
MAHARASHTRA
400018
India 
Phone  8983074408  
Fax    
Email  dr.nileshtiwari@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Geeta D. Parulkar 
Designation  Professor 
Affiliation  R.A Podar Medical College(Ayu), Mumbai 
Address  Department- Kayachikitsa First Floor, Casaulty Building R.A Podar Medical College(Ayu), Dr. A.B Road,Worli, Mumbai

Mumbai
MAHARASHTRA
400018
India 
Phone  8652694332  
Fax    
Email  geeta.parulkar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Nileshkumar Samarjit Tiwari 
Designation  PhD Scholar 
Affiliation  R.A Podar Medical College(Ayu), Mumbai 
Address  Department- Kayachikitsa First Floor, Casaulty Building R.A Podar Medical College(Ayu), Dr. A.B Road,Worli, Mumbai

Mumbai
MAHARASHTRA
400018
India 
Phone  8983074408  
Fax    
Email  dr.nileshtiwari@gmail.com  
 
Source of Monetary or Material Support  
Department- Kayachikitsa First Floor, Casaulty Building R.A Podar Medical College(Ayu), Dr. A.B Road,Worli, Mumbai-400018, Maharashtra, India 
 
Primary Sponsor  
Name  DrNileshkumar Samarjit Tiwari 
Address  B 303, Trinity Garden, Vasant Nagari, Vasai East, Palghar-401208 
Type of Sponsor  Other [Self] 
 
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 Nileshkumar Tiwari  R.A Podar Medical College (Ayu)  Department of Kayachikitsa, First Floor, Casaulty Building Dr. A.B Road,Worli, Mumbai
Mumbai
MAHARASHTRA 		 8983074408

dr.nileshtiwari@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethic Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E782||Mixed hyperlipidemia. Ayurveda Condition: MEDOJA-VRUDDHIH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator Arm (Non Ayurveda)-RosuvastatinTab rosuvastatin 5mg at night in controlled group
2Comparator ArmDrugOther than Classical(1) Medicine Name: Bruhatyadi Vati, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: -koshna jal), Additional Information: -
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Age group having 25 to 60 years of age.
Obese Dyslipidemic and Non-Obese Dyslipidemic Patients (BMI-18.50 to 40.00 kg/m2) as per latest Updated WHO classification of BMI).
According to NCEP ATPIII Classification, the Pilot Project Study by Prevalence in local area and with the guidelines of CCRAS for Dyslipidemia; following were the levels to be selected for said Project.
Patient having Serum Total Cholesterol Level 200-239 mg/dl
Patient having Serum LDL Cholesterol Level 130-159 mg/dl
Patient having serum VLDL Cholesterol Level 40-60 mg/dl
Patient having Serum HDL Cholesterol Level 20-40 mg/dl
Patient having Serum Triglyceride Level 150-190 mg/dl
Patients having one or more of above levels will be selected for said project
 
 
ExclusionCriteria 
Details  Pregnant and lactating mothers.
Patients having Diabetes Mellitus.
Patients having history of Respiratory Disease Complications, Coronary Heart disease, Renal Disease Patients having Acute Complications like Severe Hypertension (B.P 150/90 mm Hg in those with age 60 years and older, and 140/90 mm Hg for adults less than 60 years. according to Eighth Joint National Committee Guideline), Hepatitis or with history of major surgery etc.
Patients having disorders like Carcinoma anywhere in the body etc.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Changes in Lipid Profile by Bruhatyadi Vati towards the Normal levels.
 		 Outcome will be assessed at baseline, 4 weeks & 8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  nil 
 
Target Sample Size   Total Sample Size="106"
Sample Size from India="106" 
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 1 
Date of First Enrollment (India)   01/07/2025 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [dr.nileshtiwari@gmail.com].

  6. For how long will this data be available start date provided 30-04-2025 and end date provided 30-04-2029?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   Dyslipidemia is a major risk factor for cardiovascular disease, the leading cause of deaths.
Currently available Hypolipidemic drugs are either expensive or often related to side effects. Hence there has been a pursuit for new safe and effective polyherbal drug for Dyslipidemia.
 
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