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CTRI Number  CTRI/2024/08/071946 [Registered on: 06/08/2024] Trial Registered Prospectively
Last Modified On: 02/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A Clinical trial to study the effect of Triphla Gomutra Bhawit Trikatu Churna in the patient of hyperlipidemia  
Scientific Title of Study   A Clinical Study to Evaluate the Efficacy of Triphla Gomutra Bhawit Trikatu Churna [TGT Capsule (Hypothetical)] in the Management of Medo Dushti w.s.r. to Hyperlipidemia 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prof Ravi Sharma 
Designation  professor and HOD in Kaya chikitsa dept.  
Affiliation  MMM Govt Ayurved College,Udaipur 
Address  MMM Govt Ayurved College,Udaipur pin 313001

Udaipur
RAJASTHAN
313001
India 
Phone  9414419259  
Fax    
Email  rspgkcj2015@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Ravi Sharma 
Designation  professor and HOD in Kaya chikitsa dept.  
Affiliation  MMM Govt Ayurved College,Udaipur 
Address  PG Dept of Kaya Chikitsa MMM Govt Ayurved College Udaipur pin 313001

Udaipur
RAJASTHAN
313001
India 
Phone  9414419259  
Fax    
Email  rspgkcj2015@gmail.com  
 
Details of Contact Person
Public Query  
Name  Prof Ravi Sharma 
Designation  professor and HOD in Kaya chikitsa dept.  
Affiliation  MMM Govt Ayurved College,Udaipur 
Address  PG Dept of Kaya Chikitsa MMM Govt Ayurved College

Udaipur
RAJASTHAN
313001
India 
Phone  9414419259  
Fax    
Email  rspgkcj2015@gmail.com  
 
Source of Monetary or Material Support  
nil 
 
Primary Sponsor  
Name  MMM govt Ayurved college 
Address  Rada ji Circle Udaipur Rajasthan pin 313001 
Type of Sponsor  Other [Govt Ayurved College] 
 
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 Ruhi Zahir  MMM GOVT. Ayurved college  PG dept of kaya chikitsa, room no.2
Udaipur
RAJASTHAN 		 9314686852

dr.ruhizahir@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics committee MMMGAC Udaipur  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: MEDOVAHASROTODUSHTIH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: Triphla Gomutra Bhawit Trikatu Churna , Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: warm water), Additional Information: -
2Comparator ArmDrugOther than Classical(1) Medicine Name: Placebo, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: warm water), Additional Information: -
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Patient willing for the trial with consent.
2. The patients who age in between 20–70 years will be selected.
3. Patients with previously diagnosed and confirmed known patient of Hyperlipidemia.
4. The patients having clinical signs and symptoms due to Medo Dushti (Hyperlipidemia)
 
 
ExclusionCriteria 
Details  1. Patients below the age of 20 years and above 70 years.
2. Patients having major illness malignancy, renal insufficiency etc.
3. Heavy drinkers and drug abusers.
4. Pregnant and lactating women.
5. Patients having Peptic ulcers or any other bleeding disorders.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Kshudra Shwash (Dyspnoea)2. Sadan(Fatigue) 3. Daurgandhya (Bad Body Odour)4. Swedadhikya (Sweating)5. Snigdhata (Unctuous skin)6. Confusion like symptoms will be analysed

 		 3 months
 
 
Secondary Outcome  
Outcome  TimePoints 
lipid profile will be analyzed  3 months 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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 
Date of First Enrollment (India)   15/08/2024 
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="0"
Months="3"
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 - NO
Brief Summary   This is a parallel group study to evaluate the efficacy of Triphla Gomutra Bhawit Trikatu Churna [TGT Capsule (Hypothetical)] in the management of Hyperlipidemia. In this study 2 groups are selected. Group-A-Trial Group- 50 well diagnosed patients of Hyperlipidemia will be administered with Triphla Gomutra Bhawit Trikatu Churna [TGT Capsule (Hypothetical)] 500 mg two cap. BD  for 90 days. Group-B –Control Group- 50 well diagnosed patients of Hyperlipidemia will be administered with Placebo (roasted semolina powder) 500 mg two cap. BD  for 90 days. Pathya-Apathya will be advised as per Ayurvedic classics followed in both groups. 
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