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CTRI Number  CTRI/2011/12/002298 [Registered on: 27/12/2011] Trial Registered Retrospectively
Last Modified On: 02/10/2012
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Cerebral palsy and its management with ayurveda 
Scientific Title of Study   A clinical study on the management of cerebral palsy with samvardhan ghrita and yoga basti 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Pavan Gor 
Designation  PG Scholar Department of Kaumarabhritya 
Affiliation  Institute for Post Graduate Teaching and Research in Ayurveda 
Address  Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University Jamnagar

Jamnagar
GUJARAT
361008
India 
Phone  9427167166  
Fax    
Email  pavanayurveda@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr K S Patel  
Designation  Associate Professor & Head, Department of Kaumarabhritya  
Affiliation  Institute for Post Graduate Teaching and Research in Ayurveda 
Address  Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University Jamnagar

Jamnagar
GUJARAT
361008
India 
Phone  0288-2552014  
Fax    
Email  drkspatel2007@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr V K Kori  
Designation  Asst. Prof., Department of Kaumarabhritya  
Affiliation  Institute for Post Graduate Teaching and Research in Ayurveda 
Address  Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University Jamnagar

Jamnagar
GUJARAT
361008
India 
Phone    
Fax    
Email  drvkkori@yahoo.co.in  
 
Source of Monetary or Material Support  
Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University Jamnagar – 361008  
 
Primary Sponsor  
Name  Institute for Post Graduate Teaching and Research in Ayurveda 
Address  Gujarat Ayurved University Jamnagar – 361008  
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
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 Pavan Gor  Department of Kaumarabhritya  OPD no.15A Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University Jamnagar – 361008
Jamnagar
GUJARAT 		 9427167166

pavanayurveda@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University Jamnagar – 361008 Vide Ref- PGT/7-A/Ethics/2011-2012/2087 dated 05/09/2011  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Cerebral palsy,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Samvardhan ghrita  Group B Samvardhan Ghrita was given as internal medication and dose was fixed as per the referance of Sharangdhar Samhita Purva Khanda 6 14to17 
Intervention  samvardhan ghrita & yoga basti  Group A (intervention) Yoga Basti In this protocol 5 days of Udvartana with Yava and Kulattha churna for 20 minute 5 days of Abhyanga with luke warm Bala Taila for 20 minute 8 days of Yoga Basti in which Anuvasana and Asthapana basti dose was fixed as per the classical reference of Charak Samhita Siddhi Sthana 3 31to32 this whole protocol is repeated for 3 times with the interval of 14 days in between during this whole treatment Samvardhan Ghrita was given as internal medication and dose was fixed as per the referance of Sharangdhar Samhita Purva Khanda 6 14to17  
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  children with severe type of disbility (GMFCS score upto 5) 
 
ExclusionCriteria 
Details  children with major congenital disorder viz.diabetes,acute infection 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Spasticity reduced by some extend
Passive range of motion, muscle power mildly
improved  		 upto present study 
 
Secondary Outcome  
Outcome  TimePoints 
RRTI and GIT problems reduced markedly  upto present study 
 
Target Sample Size   Total Sample Size="16"
Sample Size from India="16" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   Phase 1 
Date of First Enrollment (India)   23/11/2011 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   not yet published 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   This study is a randomized parallel clinical study to evaluate the efficacy of samvardhan ghrita along with yoga basti. In one group we have taken Samvardhan ghrita orally for 62 days, while in other group Samvardhan ghrita with yoga basti.Later group  Udvartana (rubbing body skin with barley & horse gram flour) for 5 days,abhyanga(massage by medicated oil named bala tail) for 5 days.Then course of yoga basti (total 8 ayurvedic medicated enema).This whole procedure (from udvartana to basti) will be repeated for total 3 times in that manner that gap between each course will be 16 days(total 84 days={course 1- 5+5+8+16 days interval} {course 2- 5+5+8+16days interval} {course 3- 5+5+8}).In basti group ghrita will be given throughout 3 course except 24 days of basti.
Patient were assessed before and after treatment by objective parameters like,
GMFCS score Ashworth scale MRC scale Barthel’s ADL score MACS CDC
 
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