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CTRI Number  CTRI/2024/10/075876 [Registered on: 25/10/2024] Trial Registered Prospectively
Last Modified On: 23/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Physiotherapy (Not Including YOGA)
Other (Specify) [Marma therapy ]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To Evaluate the Response of Etipathogenesis Based Marma Therapy on Spastic Cerebral Palsy Patients and To Design a Project on Wellequipped Center of Neurological Disorders  
Scientific Title of Study   To Evaluate the Response of Etipathogenesis Based Marma Therapy on Spastic Cerebral Palsy Patients and To Design a Project on Well-equipped Center of Neurological Disorders  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prof BM singh 
Designation  Professor  
Affiliation  Institute of medical sciences, BHU 
Address  department of Kaumarbhritya/Bal Roga, Faculty of Ayurveda, IMS, BHU, Varanasi, India

Varanasi
UTTAR PRADESH
221005
India 
Phone  9415286910  
Fax    
Email  bms@bhu.ac.in  
 
Details of Contact Person
Scientific Query  
Name  Prof BM Singh 
Designation  professor  
Affiliation  Institute of medical sciences, BHU 
Address  department of Kaumarbhritya/Bal Roga, Faculty of Ayurveda, IMS, BHU, Varanasi, India

Varanasi
UTTAR PRADESH
221005
India 
Phone  9415286910  
Fax    
Email  bms@bhu.ac.in  
 
Details of Contact Person
Public Query  
Name  Shree Devvrat ji 
Designation  Scholar 
Affiliation  Institute of medical sciences, BHU 
Address  department of Kaumarbhritya/Bal Roga, Faculty of Ayurveda, IMS, BHU, Varanasi, India

Varanasi
UTTAR PRADESH
221005
India 
Phone  7037309005  
Fax    
Email  shreedevvratji@gmail.com  
 
Source of Monetary or Material Support  
Monetary by Proff.B.M.Singh,Sir Sunderlal Hospital,Institute of Medical Sciences, Banaras Hindu University, Varanasi, 221005, Uttar Pradesh, India 
 
Primary Sponsor  
Name  Banaras Hindu University 
Address  Sir Sunderlal Hospital,Institute of Medical Sciences, Banaras Hindu University, Varanasi, 221005, Uttar Pradesh, India 
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 
Prof Bm Singh  Sir sunderlal hospital ims, bhu  OPD no 25 Department of Kaumarbhritya/Bal Roga, Faculty of Ayurveda, IMS, BHU, Varanasi, India
Varanasi
UTTAR PRADESH 		 09415286910

bms@bhu.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics committe, Insitute of medical sciences, Banaras Hindu University,Varanshi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:G00-G99||Diseases of the nervous system. Ayurveda Condition: VATAVYADHIH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-marmacikitsA, मर्मचिकित्सा (Procedure Reference: Sushrut sharir 6, Procedure details: Out of 107 Marma, the following important Marma points are considered for the evaluation of quadriplegic CP cases. 1. Sthapni Marma, 2. Shringataka Marma, 3. Maniobandh Marma, 4. Amsa Marma, 5. Ani Marma 6. Apalapa Marma, 7. Gulph Marma, 8. Simanta Marma.Perform the massage motion in a clockwise motion forward from right to left as it started from 12 to 1, 2, 3 & so on, & counterclockwise manner backward from left to right to left from 12 to 11, 10, 9 & so on.)
2Comparator ArmProcedure-aBya~ggaH, अभ्यंग  (Procedure Reference: Charak sutrasthana , Procedure details: Medicated Oil application on whole body followed by swedana karma & basti karma)
 
Inclusion Criteria  
Age From  6.00 Month(s)
Age To  16.00 Year(s)
Gender  Both 
Details  cerebral palsy patient specialy spastic cerebral palsy patient  
 
ExclusionCriteria 
Details  children suffering from any acute life-threatening illness
any congenital malformation or genetic disorder 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
GMFCS Level Assessment
Goniometer Assessment
Language Milestone
Investigation as per IPD protocol 		 At registration 15th day and after 1 month of registration  
 
Secondary Outcome  
Outcome  TimePoints 
To improve quality of life & reduce spasticity  At registration 15th day & 1 month after registration  
 
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   N/A 
Date of First Enrollment (India)   03/11/2024 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Marma therapy is an ancient therapy describe in our ayurvedic text of Samhitta. In ayurveda text 107 Marma point describe .In this trial i choose some special Marma to reduce the spasticity or improve the quality of life cerebral palsy patient.  
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