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CTRI Number  CTRI/2024/11/077190 [Registered on: 21/11/2024] Trial Registered Prospectively
Last Modified On: 15/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Physiotherapy (Not Including YOGA) 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Effect of upanaham on head and body in reducing spasticity in children having spastic cerebral palsy  
Scientific Title of Study   A Non- randomised controlled trial to evaluate the effect of upanaha on head and body as compared to physiotherapy in spasticity of children with spastic cerebral palsy aged 3- 12 years  
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  JEETHADEV 
Designation  PG SCHOLAR 
Affiliation  GOVERNMENT AYURVEDA COLLEGE THIRUVANANTHAPURAM 
Address  Department of Kaumarabhrithya,OP No 1, ground floor, Hospital block, Government Ayurveda College Hospital for Women and Children,Poojapura
Department of Kaumarabhrithya,OP No1, ground floor, hospital building,Government Ayurveda College Hospital for Women and Children,Poojapura,695012
Thiruvananthapuram
KERALA
695012
India 
Phone  9567497633  
Fax    
Email  pj.jeethadev@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR ROSHNI ANIRUDHAN 
Designation  PROFESSOR AND HEAD 
Affiliation  GOVERNMENT AYURVEDA COLLEGE THIRUVANANTHAPURAM 
Address  Department of Kaumarabhrithya,Faculty room, New hospital building, First floor,Government Ayurveda College Hospital for Women and Children, Poojapura.
Department of Kaumarabhrithya,Faculty room, New hospital building, First floor, Government Ayurveda College Hospital for Women and Children, Poojapura.
Thiruvananthapuram
KERALA
695012
India 
Phone  9447006585  
Fax    
Email  doctoroshni@gmail.com  
 
Details of Contact Person
Public Query  
Name  JEETHADEV 
Designation  PG Scholar 
Affiliation  GOVERNMENT AYURVEDA COLLEGE THIRUVANANTHAPURAM 
Address  Department of Kaumarabhrithya, Op no:1, Ground floor, Hospital block, Government Ayurveda College Hospital for Women and Children, Poojapura
Department of Kaumarabhrithya,Op No:1, Ground floor, Hospital block, Government Ayurveda college Hospital for women and children, Poojapura.
Thiruvananthapuram
KERALA
695012
India 
Phone  9567497633  
Fax    
Email  pj.jeethadev@gmail.com  
 
Source of Monetary or Material Support  
GOVERNMENT AYURVEDA COLLEGE HOSPITAL FOR WOMEN AND CHILDREN ,TC17/1426,CHENGALLOR ROAD, CHERUKARA GARDENS, POOJAPPURA,THIRUVANANTHAPURAM,PIN 695012,KERALA,INDIA. 
 
Primary Sponsor  
Name  JEETHADEV PJ 
Address  PG scholar,Department of Kaumarabhrithya, Op no:1, Ground floor, Hospital Block, Government Ayurveda College Hospital for Women and Children, Poojapura,Thiruvanathapuram Kerala ,India,Pin- 695012 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
JEETHADEV PJ  Government Ayurveda College Hospital for Women and Children, Poojapura,Thiruvanathapuram 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Jeethadev PJ  Government Ayurveda College Hospital for Women and Children,Poojappura.  Department of Kaumarabhrithya,OP No:1,Ground floor, Hospital Block
Thiruvananthapuram
KERALA 		 9567497633

pj.jeethadev@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee,Government Ayurveda college Thiruvananthapuram  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: SARVANGAROGAH/SARVANGAVATAH (KEVALAVATA),  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator Arm (Non Ayurveda)-PhysiotherapyDaily 1 hour for 30 days
2Intervention ArmProcedure-upanAhaH (niragniH), उपना,हः (निरग्निः),(siro upanaha) (Procedure Reference: Charaka samhitha , Procedure details: Upanaha Choorna mentioned in Ashtangahridaya swedadahyaya along with fine powder of masha,kulatha and thina are taken and used for upanaha after mixing with mustha thakram.Mustha thakram the medium of mixing powdered drugs is prepared by boiling crushed mustha(50g)in 500ml milk and fermenting it overnight .Next day formed buttermilk has to be churned and mixed with upanaha choorna and again kept overnight.Thus formed paste is used for upanha of head (7 days)and body(30 days) )
(1) Medicine Name: Upanaha choornam, Reference: Ashtangahridaya swedadhyaya, Route: Topical, Dosage Form: Churna/ Powder, Dose: 1000(g), Frequency: od, Duration: 1 Months
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  Clinically diagnosed cases of Spastic Cerebral palsy. 
 
ExclusionCriteria 
Details  Children with spastic cerebral palsy associated with Known cases of Systemic infectious/inflammatory conditions,Metabolic disorders, neuro degenerative diseases,History of recurrent lower respiratory infections,Children having intractable epilepsy etc will be excluded
Local skin eruptions at the site of bandage
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Reduction of spasticity after doing Siroupanha for 7days and upanaha in spastic limbs for 30 days  4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   29/11/2024 
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="6"
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   Participants of age group 3-12 years statisfying the inclusion criteria attending the OPD will be included in the study.After doing initial assessments subjects in both the groups will be recruited to either trial group or control group.The trial group will be given upanaha for head and body after physiotherapy under the guidance of qualified physiotherapist for specific duration after assessing spasticity of limbs.Upanaha for Head is for 7 days upanaha for body is for 30 days for 3-4 hours a day.Controll group will be given physiotherapy for 30 days under the guidance of qualified physiotherapist of the department.Participants will be assessed before and after treatment and after followup period using internationally accepted tools such as Ashworth scale for assesing spasticity,Goniometric evaluation to assess range of motion .A follow up assessment will be done after 1 month of intervention.  
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