FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2019/10/021767 [Registered on: 23/10/2019] Trial Registered Prospectively
Last Modified On: 08/09/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study to see the purgation effect of Trivrut powder and fortified Trivrut powder in healthy persons. 
Scientific Title of Study   A comparative clinical study on effect of Bhavita Trivrut Churna and Trivrut Churna as Virechaka yoga in healthy individuals 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Lal Ravi Sahu 
Designation  Assistant Professor 
Affiliation  Parul Institute of Ayurved 
Address  Department of Panchakarma, Parul Institute of Ayurved, Limda

Vadodara
GUJARAT
391760
India 
Phone  7582802777  
Fax    
Email  rvsh312@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  K B Roy 
Designation  Professor 
Affiliation  Parul Institute of Ayurved 
Address  Department of Panchakarma, Parul Institute of Ayurved, Limda

Vadodara
GUJARAT
391760
India 
Phone    
Fax    
Email  kanubhai.roy@paruluniversity.ac.in  
 
Details of Contact Person
Public Query  
Name  K B Roy 
Designation  Professor 
Affiliation  Parul Institute of Ayurved 
Address  Department of Panchakarma, Parul Institute of Ayurved, Limda

Rajkot
GUJARAT
391760
India 
Phone    
Fax    
Email  kanubhai.roy@paruluniversity.ac.in  
 
Source of Monetary or Material Support  
Parul Ayurved Hospital, Limda, Vadodara, Gujarat , India 391760 
 
Primary Sponsor  
Name  Parul Ayurved Hospital 
Address  Parul University Campus Limda 
Type of Sponsor  Private medical 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 Lal Ravi Sahu  Parul Ayurveda Hospital  Department of Panchakarma,Limda Waghodia Vadodara, Gujarat 391760
Vadodara
GUJARAT 		 7582802777

rvsh312@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics committee for human research Parul institute of ayurved parul university  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Heathy 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Bhavit Trivrut Churna  Bhavit Trivrut Churna 12 grams with Honey for one day on the day of Virechana by oral route.Duration of clinical trial for 1 subject will be of 14-21 days.  
Comparator Agent  Trivrut Churna   Trivrut Churna 24 Grams with honey for one day on the day of Virechana by oral route.Duration of clinical trial for 1 subject will be of 14-21 days. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Healthy individuals with Madhyama Koshta who do not complain any type of physical illness.Whose routine clinical examination and laboratory investigations reveal no abnormality. Individuals between the age group of 18 to 60 of either gender.
 
 
ExclusionCriteria 
Details  Individuals with physical or mental ailments or with altered routine lab investigation.Persons who are contraindicated for Virechana.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Purgation and Detoxification of of lower intestine.   After 3rd day of Dipana Pachana 5th day of Snehapana,Virechana, 5th Samsarana krama 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in quality of life, hunger, digestion  5-7 day of samsarjana krama 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="90" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/11/2019 
Date of Study Completion (India) 08/09/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Virechana is one among the Shodhana procedure which is used for Atura as well as Swastha. Whenever an individual indulge in Ahara and Vihara which provoke a particular Dosha in its aggravated stage, may produce respective disorders. So, Shodhana becomes mandatory choice in order to eliminate the same. Shodhana is advocated periodically in order to prevent diseases like obesity, digestive disturbances, diabetes mellitus, skin disorders, insomnia, and psychiatric illness. For instance, accumulated Pitta may produce disorders of Pitta if it is not eliminated in Sharad Rutu. The vitiated Dosha, if removed in their Sanchaya Avastha itself, they will not go to their next stages, where they gain strength. If they are not eliminated in time then they may unite with Dushya like Rasa and produce grave disorders. So Shodhana is very important for healthy individuals for prevention from seasonal diseases.Trivrut is considered as best among all Virechaka Dravya. The ideal medicine for Shodhana is one which is given in Alpamatra, induces Mahavega, Bahudoshahara, Sukha-Shodhaka, Laghu-paka, Sukha-Swada. The routinely practiced Virechaka Yogas are of high dose and less palatable. Bhavana-Samskara enhances the potency of the drug and thus reduces the dose. So the study has been framed on Bhavita Trivrut Churna to assess the efficacy as Virechaka Yoga in healthy individuals.

 
Close