| CTRI Number |
CTRI/2020/06/025773 [Registered on: 10/06/2020] Trial Registered Prospectively |
| Last Modified On: |
16/05/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Management of cerebral palsy through Ayurveda |
|
Scientific Title of Study
|
“EFFICACY OF MATRA BASTI AND SHASHTIKA SHALI PINDA SWEDA 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 |
Adhyaru Vrushti P |
| Designation |
MD second year |
| Affiliation |
IPGT and RA Gujrat Ayurved University Jamnagar |
| Address |
Department of Kaumarbhritya IPGT and RA 5th floor Institute main building IPGT and RA Gujrat Ayurveda University Jamnagar
Department of Kaumarbhritya IPGT and RA 5th floor Institute main building IPGT and RA Gujrat Ayurveda University Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
8866286291 |
| Fax |
|
| Email |
vrushtiadhyaru@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof K S Patel |
| Designation |
Professor and HOD Kaumarbhritya Department, IPGT AND RA, Jamnagar |
| Affiliation |
IPGT and RA Gujrat Ayurveda University Jamnagar |
| Address |
Department of Kaumarbhritya IPGT and RA 5th floor Institute main building IPGT and RA Gujrat Ayurveda University Jamnagar
Department of Kaumarbhritya IPGT and RA 5th floor Institute main building IPGT and RA Gujrat Ayurveda 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 |
| Affiliation |
IPGT and RA, Gujrat Ayurved University Jamnagar |
| Address |
Department of Kaumarbhritya IPGT and RA 5th floor Institute main building IPGT and RA Gujrat Ayurveda University Jamnagar
Department of Kaumarbhritya IPGT and RA 5th floor Institute main building IPGT and RA Gujrat Ayurveda University Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9409207485 |
| Fax |
|
| Email |
drvkkori@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Director IPGT and RAr |
| Address |
IPGT and RA GAU Jamnagar |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Vrushti Adhyaru |
IPGT and RA, Jamnagar |
IPD Ward Department of Kaumarbhritya Fourth flour IPGT and RA GAU
Jamnagar
GUJARAT |
8866286291
vrushtiadhyaru@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE INSTITUTE FOR POST GRADUATE TEACHING AND RESEARCH IN AYURVEDA GUJRAT AYURVED UNIVERSITY JAMNAGAR 361008 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G809||Cerebral palsy, unspecified, (2) ICD-10 Condition: G809||Cerebral palsy, unspecified, (3) ICD-10 Condition: F848||Other pervasive developmental disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A Matra Basti
|
In group A Matra Basti (8Days)with Samvardhana Ghrita will be given for three courses and throughout the treatment 74 daysinternal medicine named Medhya Churna will also be given contents of Medhya Churna are Yashtimadhu Guduchi Vacha Brahmi Pippali Shankhapushpi with Anupana Madhu dose calculated as per age mentiened in Sharangadhara Samhita in two divided doses |
| Comparator Agent |
Group B Shashtika Shali Pinda Sweda |
In Group B Shashtika Shali Pinda Sweda will be given for three courses and throughout the treatment schedule of 74 days internal medicine named Medhya Churna will also be given Content of Medhya Churna are Yashtimadhu Guduchi Vacha Brahmi Pippali Shankhapushpi with Anupana Madhu. Dose Calculated as per age mentioned in Sharangadhara Samhita in two divided doses |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed children of cerebral Palsy of either sex of 6 month to 10 years of age
Children with developmental disability both either physical or mental in mild or moderate degree as compare to other normal children |
|
| ExclusionCriteria |
| Details |
Children below 6 month of age and above 10 years
Children of Cerebral Palsy with major congenital disorders |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| spasticity muscle power and general health condition assessment by specially prepared performa |
2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| assess quality of life BY special prepared performa |
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)
|
01/07/2020 |
| 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="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 Matra Basti and Shashtika Shali Pinda Sweda ( A schedule of 8 days in which medicine will be given through anal route and special type of Sweadana will be done) in the management of cerebral palsy There are two groups for the study purpose In group A three sittings of Matra Basti will be carried out In group B Shashtika Shali Pinda Sweda will be carried out An interval between each sitting are 10 days. In both groups Medhya Churna (combination of dry powder of six herbal drugs) will be administered as an internal medicine throughout the treatment schedule of 74 days with Anupana ( vehicle or adjuvent) Madhu (Honey) Follow up period is 8 weeks for both the groups |