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CTRI Number  CTRI/2022/02/040295 [Registered on: 15/02/2022] Trial Registered Prospectively
Last Modified On: 14/02/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Ayurvedic management of spastic cerebral palsy affected children in comparison to physiotherapy 
Scientific Title of Study   A Randomized controlled trial to evaluate the efficacy of ‘Ayurvedic management protocol’ and Physiotherapy in functional improvement of Spastic Cerebral Palsy affected children 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prof Bharat Bhoyar 
Designation  Professor 
Affiliation  Shri Krishna AYUSH University, Kurukshetra 
Address  Room No 104, Department of kaumarbhritya, CBPACS, Khera dabar, SWD, New Delhi

South West
DELHI
110073
India 
Phone  09891954426  
Fax    
Email  bharatbhoyar@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Amit Kataria 
Designation  Associate Professor 
Affiliation  Shri Krishna Ayurved College 
Address  Department Of Kaumarbhritya, Shri Krishna Ayurved College, Shri Krishna AYUSH University, Kurukshetra, Haryana

Kurukshetra
HARYANA
136118
India 
Phone  9034001230  
Fax    
Email  dramitkataria@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Amit Kataria 
Designation  Associate Professor 
Affiliation  Shri Krishna Ayurved College 
Address  Department Of Kaumarbhritya, Shri Krishna Ayurved College, Shri Krishna AYUSH University, Kurukshetra, Haryana

North
HARYANA
136118
India 
Phone  9034001230  
Fax    
Email  dramitkataria@rediffmail.com  
 
Source of Monetary or Material Support  
1. Shri Krishna AYUSH University, Kurukshetra, Haryana 2. Ch Brahm Prakash Ayurved Charak Sansthan, Khera Dabar, Delhi 
 
Primary Sponsor  
Name  Shri Krishna AYUSH University 
Address  Umri Road, Sector-8, Kurukshetra, Haryana 
Type of Sponsor  Other [Govt AYUSH University] 
 
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 
Prof Bharat Bhoyar  Ch Brahm Prakash Ayurved Charak Sansthan  OPD No. 8, Department of Kaumarbhritya, CBPACS, Khera Dabar, Najafgarh, Delhi
South West
DELHI 		 9891954426

bharatbhoyar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee-CBPACS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:G801||Spastic diplegic cerebral palsy. Ayurveda Condition: Vata vyadhi, (2) ICD-10 Condition:G800||Spastic quadriplegic cerebral palsy. Ayurveda Condition: Vata vyadhi, (3) ICD-10 Condition:G802||Spastic hemiplegic cerebral palsy. Ayurveda Condition: Vata vyadhi,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Brahm Rasayana, Reference: charak Samhita, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 7.5(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information:
2Intervention ArmProcedure-bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म (Procedure Reference: Kashyapa Samhita, Procedure details: Age appropriate dose of Anuvasana & niruha basti- three sets Chaturbhadra basti Kalp (12 dyas bast in each set- 4 niruha and 8 anuvasana))
(1) Medicine Name: Ksheerabala Tail, Reference: The Ayurvedic Pharmacopia of India, Route: Rectal, Dosage Form: Taila, Dose: 100(ml), Frequency: od, Duration: 24 Days
(2) Medicine Name: Sahacharadi Asthapan, Reference: Charak Samhita, Route: Rectal, Dosage Form: Not Applicable, Dose: 400(ml), Frequency: od, Duration: 12 Days
3Comparator Arm (Non Ayurveda)-physiotherapyStandard protocol of physiotherapy for cerebral palsy for 30 minutes daily for 90 days
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  Children of either sex having Spastic cerebral palsy .
Cases between age group 1 year to 10 years of either gender.
Either parent should be willing and capable of following instructions 
 
ExclusionCriteria 
Details  Patients undergoing any other allopathic medication.
Patients associated with severe or profound mental retardation.
Children with fixed contractures and deformities affecting stature and gait.
Children with acute or chronic illness that can interfere the intervention.
Any other condition, which as per the investigator would jeopardize the outcome of the trial
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Reduction in spasticity and increased use of muscle groups for activity of daily living
2. Attaining of motor milestones 
Baseline
30 days
60 days
90 days 
 
Secondary Outcome  
Outcome  TimePoints 
improvement in quality of life  90 days 
 
Target Sample Size   Total Sample Size="62"
Sample Size from India="62" 
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   N/A 
Date of First Enrollment (India)   18/02/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  18/02/2022 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   will be published in relevant journal 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary    
Cerebral Palsy is a group of permanent disorders of the development of movement and posture, causing activity limitations that are attributed to non-progressive disturbances that occurred in the developing fetal or infant brain. The Global incidence of CP is 3.6 per 1000 live births. The  prevalence of Spastic Cerebral Palsy in children  in India is 2.95 per 1000 live children. Its worldwide incidence is 2 to 2.5 per 1000 live births.5,6 while in India it is 2-4 per 1000 live birth. Clinical manifestation of Spastic Cerebral palsy is similar to Vata Vyadhi. Therefore in practice it is managed on the same line by Ayurvedic physicians. Basti Chikitsa and use of Rasayana drugs are the treatment of  choice for vatavyadi. Ayurvedic interventions in cerebral palsy on the line of Vata Vyadhi, have given effective results. However very limited RCTs are available on the same. The high incidence of CP, less parent satisfaction for allopathic management, there is acute need of randomized controlled trial. Considering the same this present study has been planned.
 
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