| CTRI Number |
CTRI/2015/09/006207 [Registered on: 23/09/2015] Trial Registered Retrospectively |
| Last Modified On: |
22/09/2015 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Ayurvedic treatment for Cerebral palsy
|
|
Scientific Title of Study
|
Management of Cerebral palsy with Chaturbhadra kalpa basti and yogabasti |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sonam P Kanzode |
| Designation |
MD second year |
| Affiliation |
IPGTRA Jamnagar |
| Address |
PG Girls hostel Room no 122 IPGTRA Jamnagar
Dept of Kaumarbhritya IPGTRA Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
8140978927 |
| Fax |
|
| Email |
sonamkanzode@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr V K KORI |
| Designation |
Astt professor |
| Affiliation |
IPGTRA Jamnagar |
| Address |
Dept of kaumarbhritya IPGTRA Jamnagar 361008
Dept of kaumarbhritya IPGTRA Jamnagar 361008
Jamnagar
GUJARAT
361008
India |
| Phone |
9374548475 |
| Fax |
|
| Email |
drvkkori@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr K S PATEL |
| Designation |
Professor and HOD |
| Affiliation |
IPGTRA Jamnagar |
| Address |
Dept of kaumarbhritya IPGTRA Jamnagar 361008
Dept of kaumarbhritya IPGTRA Jamnagar 361008
Jamnagar
GUJARAT
361008
India |
| Phone |
9427574566 |
| Fax |
|
| Email |
drkspatel2007@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
IPGTRA GAU Jamnagar |
| Address |
IPGTRA 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 |
| Dr V K Kori |
PG Hospital IPGTRA JAMNAGAR |
PG HOSPITAL Kaumarbhritya Dept ward fourth floor IPGTRA JAMNAGAR
Jamnagar
GUJARAT |
9374548475
drvkkori@yahoo.com |
|
|
Details of Ethics Committee
|
| 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 PGT/7/-A/Ethics/2014-15/1538 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients diagnosed with cerebral palsy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Chaturbhadra kalpa basti |
In group A Chaturbhadra kalpa basti and MEDHYA CHURNA FOR INTERNAL MEDICATION through out the treatment schedule for 94 days contents of Medhya churna are yashtimadhu guduchi vacha brahmi pippalimul shankhapushpi with anupana madhu |
| Comparator Agent |
Yoga basti |
In In group A Yoga basti basti and MEDHYA CHURNA FOR INTERNAL MEDICATION through out the treatment schedule for 82 days contents of Medhya churna are yashtimadhu guduchi vacha brahmi pippalimul shankhapushpi with anupana madhu |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
1. Diagnosed Children of C.P. of either sex, of 6 months to 10yrs of age.
2. Children with developmental disability both either physical or mental, in mild or moderate degree as compared to other normal children. |
|
| ExclusionCriteria |
| Details |
1. Children of age < 6 months and > 10 yrs.
2. Children of C.P. with major congenital disorder and other disease status viz. Juvenile Diabetes, Acute infections etc.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
lower down the spasticity
increse in muscle power improvement in general health |
lower down the spasticity
increse in muscle power improvement in general health |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Enhance the quality of life of cerebral palsy child |
Enhance the quality of life of cerebral palsy child and reduce the burden on parents |
|
|
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)
|
26/02/2015 |
| 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="5"
Days="18" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is randomised clinical trial to study Management of cerebral palsy with chaturbhadra kalpa basti and yoga basti.In group A 3 seatings of chaturbhadra kalpa bast iwith an interval of 14 days and in group B 3 seatings of yoga basti with an interval of 14 days will be done.In both the groups Medhya churna will be taken as an internal medicine through out the treatment schedule with anupana madhu.Follow up period is 2 months for both the groups.
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