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CTRI Number  CTRI/2022/07/044373 [Registered on: 27/07/2022] Trial Registered Prospectively
Last Modified On: 17/07/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Preventive 
Study Design  Other 
Public Title of Study   Study on Sharada Ritu(September to November),to evaluate the effect of Virechana Karma on Pitta prakop during Sharada Ritu. 
Scientific Title of Study   A Study on Sharada Ritu and to evaluate the effect of Virechana Karma on naturally vitiated Pitta  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rajika Gupta 
Designation  Reader and HOD 
Affiliation  Rajiv Gandhi Government Post Graduate Ayurvedic College  
Address  Anatomy Block Room no. 410 Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola District Kangra Pin 176115

Kangra
HIMACHAL PRADESH
176115
India 
Phone  9805880254  
Fax    
Email  rajikadr@rediffmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rajika Gupta 
Designation  Reader and HOD 
Affiliation  Rajiv Gandhi Government Post Graduate Ayurvedic College  
Address  Anatomy Block Room no. 410 Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola District Kangra Pin 176115

Kangra
HIMACHAL PRADESH
176115
India 
Phone  9805880254  
Fax    
Email  rajikadr@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Rajika Gupta 
Designation  Reader and HOD 
Affiliation  Rajiv Gandhi Government Post Graduate Ayurvedic College  
Address  Anatomy Block Room no. 410 Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola District Kangra Pin 176115

Kangra
HIMACHAL PRADESH
176115
India 
Phone  9805880254  
Fax    
Email  rajikadr@rediffmail.com  
 
Source of Monetary or Material Support  
RGGPG Ayurvedic college and hospital paprola district kangra 
 
Primary Sponsor  
Name  Rajiv Gandhi Government Post Graduate Ayurvedic College 
Address  RGGPG Ayurvedic College Paprola District Kangra Pin 176115 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
Dr Rajika Gupta  Anatomy Block Room no. 410 swasthavritta department Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola District Kangra Pin 176115 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Isha Sharma  Rajiv Gandhi ayurvedic hospital Paprola   Room no 411 Swasthavritta department anatomy block RGGPG Ayurvedic College Paprola District Kangra Pin 176115
Kangra
HIMACHAL PRADESH 		 8219358097

sharmaisha116@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEChuman  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy volunteers 
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-virecana-karma, विरेचन-कर्म Pradhan Karma(Procedure Reference: charak sidhi, Procedure details: -for 3 days deepana and pachana with panchkola churna will be done -for 3 to 7 days depending upon koshtha snehpana with murchita goghritta will be done -for next three days sarvanga abhyanga with murchitta tila tail and swedan will be performed -on fourth day virechana karma will be performed.)
(1) Medicine Name: Haritaki churna with erand tail, Reference: charak chikitsa 1/31 and charak sutra 13/12, Route: Oral, Dosage Form: Churna/ Powder, Dose: 40(g), Frequency: od, Duration: 1 Days
(2) Medicine Name: Erand taila, Reference: charak sutra 13/12, Route: Oral, Dosage Form: Taila, Dose: 100(ml), Frequency: od, Duration: 1 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  -volunteers willing for trial.
-age group 18 to 60 
 
ExclusionCriteria 
Details  -volunteers not willing for trial
-volunteers below 18 and above 60 years
-volunteers having any associated chronic illness
-pregnant and lactating mothers 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Relief from various sign and symptoms like Pitatvam,glani,indriya daurbalyam, shita abhilasha, tikta asyata,daha, Trishna,alpanidra  4 months 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in symptoms like lethargy, weakness in functioning of sense organs, feeling of burning sensation, bitter taste in mouth etc.   4 months 
 
Target Sample Size   Total Sample Size="15"
Sample Size from India="15" 
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 4 
Date of First Enrollment (India)   16/08/2022 
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="0"
Days="18" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   A clinical study to evaluate the effect of Virechana Karma on naturally vitiated Pitta in Sharada Ritu.Total fifteen apparantly healthy individuals will be selected in Sharada Ritu.Healthy volunteers will be selected from Paprola and surrounding areas . individuals will be selected on the basis of inclusion and exclusion criteria to know the effect of virechana karma. 
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