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CTRI Number  CTRI/2017/12/010880 [Registered on: 14/12/2017] Trial Registered Prospectively
Last Modified On: 13/12/2017
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Management of Cerebral Palsy through Ayurved  
Scientific Title of Study   Efficacy of Yoga Basti with and without Pratimarsha Nasya in the management of Cerebral Palsy-An open labelled, Randomized, Comparative Clinical trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Faizzehra Riyazhussain Vakil 
Designation  MD second year scholar 
Affiliation  Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University 
Address  IPGT and RA Gujarat Ayurved University Haash gali no 2 himmatnagar 1 near g g hospital jamnagar
IPGT and RA Gujarat Ayurved University Haash gali no 2 himmatnagar 1 near g g hospital jamnagar
Jamnagar
GUJARAT
361008
India 
Phone  9408968814  
Fax    
Email  fvakil137@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof K S Patel 
Designation  Professor and HOD Kaumarbhritya department IPGT and RA Jamnagar 
Affiliation  Institute for Post Graduate Teaching and Research in Ayurveda 
Address  Kaumarbhritya Department Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University Jamnagar
Kaumarbhritya Department Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University Jamnagar
Jamnagar
GUJARAT
361008
India 
Phone  9427574566  
Fax    
Email  drkspatel2007@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr V K Kori 
Designation  Associate Professor Kaumarbhritya department IPGT and RA Jamnagar 
Affiliation  Institute for Post Graduate Teaching and Research in Ayurveda 
Address  Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University Jamnagar Kaumarbhritya Department 5th floor Main Building IPGT and RA Gujarat Ayurved University Jamnagar
Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University Jamnagar Kaumarbhritya Department 5th floor Main Building IPGT and RA Gujarat Ayurved University Jamnagar
Jamnagar
GUJARAT
361008
India 
Phone  9409207285  
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 
 
Primary Sponsor  
Name  Director IPGT and RA GAU Jamnagar 
Address  IPGT and RA GAU Jamnagar 
Type of Sponsor  Research institution and hospital 
 
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 
Faizzehra Riyazhussain Vakil  PG Hospital  Kaumarbhritya Department IPD Ward fourth floor IPGT and RA Jamnagar GUJARAT
Jamnagar
GUJARAT 		 9408968814

fvakil137@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 PGT/7/-A/Ethics/2017-18/2134  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Patients diagnosed with Cerebral Palsy,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group A Yoga Basti along with Pratimarsha Nasya  In Group A Yoga Basti(8 days) with Bala taila along with Pratimarsha Nasya(7 days) with Panchendriyavivardhana taila will be given for three courses and throughout the treatment schedule of 80 days internal medicine named Medhya churna will also given Contents of Medhya Churna are Yastimadhu Guduchi Vacha Brahmi Pippali Shankhpusphi with anupana madhu dose calculated as per age mentioned in Sharangdhara Samhita in two divided dose 
Comparator Agent  Group B Yoga Basti  In Group B Yoga Basti(8 days)bwill be given for three courses and throughout the treatment schedule of 80 days internal medicine named Medhya churna will also given Contents of Medhya Churna are Yastimadhu Guduchi Vacha Brahmi Pippali Shankhpusphi with anupana madhu dose calculated as per age mentioned in Sharangdhara Samhita in two divided dose 
 
Inclusion Criteria  
Age From  6.00 Month(s)
Age To  10.00 Year(s)
Gender  Both 
Details  1 Diagnosed Children of Cerebral Palsy of either sex of 6 months to 10 yrs of age
2 Children with developmental disability both either physical or mental in mild or moderate degree as compared to other normal children 
 
ExclusionCriteria 
Details  1 Children’s age less than 6 months and greater than 10 yrs
2 Children of cerebral palsy with major congenital disorder 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Lower down the spasticity and increase in muscle
power and improvement in general health
condition 		 2 months 
 
Secondary Outcome  
Outcome  TimePoints 
Enhance the quality of life of child suffering from
Cerebral Palsy 		 3 months 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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 3 
Date of First Enrollment (India)   12/02/2018 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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 is an open labelled randomized comparative clinical trial to study the efficacy of Yoga Basti(a schedule of 8 days in which medicine given through anal route) with Bala Taila along with Pratimarsha nasya(medicated oil given through nostrils in the form of drops) with Panchendriyavivardhana Taila in the management of Cerebral Plasy. There are two groups for the study purpose. In group A three sittings of Yoga Basti with Bala Taila along Pratimarsha Nasya with Panchendriyavivardhana Taila will be carried out. In Group B three sittings of Yoga Basti with Bala Taila will be carried out. An interval of the three sittings are 10 days. In both the groups Medhya Churna(combination of dry powder of six herbal drugs) will be administered as an internal medicine throughout the treatment schedule of 80 days with anupana(vehical or adjuvant) madhu(honey). Follow up period is 8 weeks for both the groups. 
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