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CTRI Number  CTRI/2020/10/028205 [Registered on: 01/10/2020] Trial Registered Prospectively
Last Modified On: 30/09/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Treatment of Cerebral Palsy in children 
Scientific Title of Study   Effect of Ayurveda treatment modalities in motor disabilities of children with Cerebral Palsy  
Trial Acronym  AYU-CP 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shailaja Uppinakuduru 
Designation  Professor and Head 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital 
Address  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital
Hassan - 573201, Karnataka
Hassan
KARNATAKA
573201
India 
Phone  9448816433  
Fax    
Email  rao.shaila@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shailaja Uppinakuduru 
Designation  Professor and Head 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital 
Address  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital
Hassan - 573201, Karnataka
Hassan
KARNATAKA
573201
India 
Phone  9448816433  
Fax    
Email  rao.shaila@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Prasanna Narasimha Rao 
Designation  Principal and Chief Medical Officer 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital 
Address  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital,
Hassan – 573201, Karnataka, India
Hassan
KARNATAKA
573201
India 
Phone  09448064277  
Fax    
Email  profpnrao@gmail.com  
 
Source of Monetary or Material Support  
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan 
 
Primary Sponsor  
Name  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan 
Address  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan, Karnataka 
Type of Sponsor  Private medical college 
 
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 
Dr Shailaja U  SDM College of Ayurveda and Hospital  Room no. 18, Department of Kaumarabhritya, SDM Ayurveda Hospital
Hassan
KARNATAKA 		 9448816433

rao.shaila@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SDM College of Ayurveda and Hospital, Hassan  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G809||Cerebral palsy, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  1. Udwarthana with Kolakulathadi churna 2. Sarvanga Abhyanga with Tila taila 3. Sarvanga Parisheka with Dashamoola Kashaya 4. Shirodhara with Dashamoola Kashaya 5. Upanaha with Salavana upanaha churna 6. Matra basti with Murchita tila taila 7. Karna poorana with Tila taila   7 days - Udwarthana 8 days - Sarvanga Abhyanga 15 days - Sarvanga Parisheka 15 days - Shirodhara 15 days - Upanaha 15 days - Matra basti 15 days - Karna poorana  
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  Children in the age group of 2-10 years of both gender

Children whose parents are willing to sign the informed assent form

If participant history of seizures, well controlled by medication
 
 
ExclusionCriteria 
Details  Mixed variety of cerebral palsy

Children with infectious diseases like tuberculosis, meningitis

Children with poor controlled seizures, recurrent status epilepticus, intractable seizures, complex seizures, juvenile diabetes mellitus, severe cognitive impairment.

With Severe motor handicap and deformities from long standing spasticity.

The children of cerebral palsy with congenital malformations, other systemic illness like congenital heart disease, nephrotic syndrome will be excluded from the study.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Decrease of spasticity, increase of muscle power and improvement in range of movements  15 days 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
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 2 
Date of First Enrollment (India)   05/10/2020 
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="15" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   The aim of the study is to evaluate the effect of Ayurveda intervention in the management of Cerebral Palsy in children. The children with Cerebral Palsy within the age group of 2 to 10 years satisfying inclusion and diagnostic criteria will be recruited to study. The subjects will be administered with Ayurveda intervention for a period of 15 days. The assessment of spasticity, power of limbs and range of movements will be done. The data obtained will be evaluated for statistical significance at the end of study. 
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