| CTRI Number |
CTRI/2023/07/055350 [Registered on: 19/07/2023] Trial Registered Prospectively |
| Last Modified On: |
08/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
EFFECT OF DEVADARU BALADI OIL IN cerebral palsy PATIENT |
|
Scientific Title of Study
|
To Evaluate the effectiveness of Devadaru baladi tail in cerebral palsy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anjali Bhange |
| Designation |
PG Scholar |
| Affiliation |
Shri Narayan Prasad Awasthi Govt. Ayurveda College Raipur C.G. |
| Address |
Department of Kaumarabhritya Shri Narayan Prasad Awasthi Govt. Ayurveda College Raipur ( C.G.)
Department of Kaumarabhritya Shri Narayan Prasad Awasthi Govt. Ayurveda College Raipur ( C.G.)
Raipur
CHHATTISGARH
492010
India |
| Phone |
9340516046 |
| Fax |
|
| Email |
anjalibhange309@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Lowkesh chandravanshi |
| Designation |
Lecturer |
| Affiliation |
Shri Narayan Prasad Awasthi govt. Ayurvedic College raipur |
| Address |
Shri Narayan Prasad Awasthi Govt. Ayurveda College Raipur ( C.G.)
Department of kaumarbhritya, Shri Narayan Prasad Awasthi Govt. Ayurvedic College Raipur CG
Raipur
CHHATTISGARH
492010
India |
| Phone |
9827822231 |
| Fax |
|
| Email |
lowkeshc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr satyawati Rathia |
| Designation |
Lecturer |
| Affiliation |
Shri Narayan Prasad Awasthi Govt. Ayurveda College Raipur C.G. |
| Address |
Department of Kaumarabhritya Shri Narayan Prasad Awasthi Govt. Ayurveda College Raipur ( C.G.)
Department of Kaumarabhritya Shri Narayan Prasad Awasthi Govt. Ayurveda College Raipur ( C.G.)
Raipur
CHHATTISGARH
492010
India |
| Phone |
9924975823 |
| Fax |
|
| Email |
satirathiya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Kaumarabhritya Shri Narayan Prasad Awasthi Govt. Ayurveda College Raipur ( C.G.) |
|
|
Primary Sponsor
|
| Name |
Shri Narayan Prasad Awasthi Govt. Ayurveda College Raipur (C.G.) |
| Address |
Department of Kaumarabhritya Shri Narayan Prasad Awasthi Govt. Ayurveda College Raipur ( C.G.) |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Anjali Bhange |
Shri khudadad Doongaji Government Ayurveda Hospital |
Department of kaumarabhritya OPD No 7 and IPD patient Shri Khudadad Doongaji Goverment Ayurved Hospital Raipur Chhatishgarh 492010
Raipur
CHHATTISGARH |
9340516046
anjalibhange309@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| OFFICE OF THE PRINCIPAL, SHRI NARAYAN PRASAD AWASTHI GOVT. AYURVEDIC COLLEGE RAIPUR CG,492010 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G809||Cerebral palsy, unspecified. Ayurveda Condition: cerebral palsy, (2) ICD-10 Condition:G800||Spastic quadriplegic cerebral palsy. Ayurveda Condition: VATAJA VYADHI , |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: DEVADARU BALADI TAIL , Reference: SHASATRA YOGA , Route: Rectal, Dosage Form: Taila, Dose: 40(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 12 Months, anupAna/sahapAna: No, Additional Information: Dose will be calculated according to age. The dose range is 8ml to 40 ml(2) Medicine Name: DEVADARU BALADI TAIL , Reference: SHASTRA YOGA, Route: Rectal, Dosage Form: Taila, Dose: 40(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: Dose will be calculated according to age. The dose range is 8ml to 40 ml |
|
|
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Inclusion Criteria
|
| Age From |
8.00 Month(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed Cerebral palsy patient presenting featuers 0f cerebral palsy |
|
| ExclusionCriteria |
| Details |
Children age <8 months and >more than 8 years
children of C.P. with major congenital disorder and other disease status viz, juvenile Diabetes mellitus, Acute infections and other systemic disorders |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
muscles power improved
muscles rigidity reduced
child able to sitting without support |
at basline,for 12 days and then every 18 days of interval for 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| children condition improved, muscles power improved, rigidity and spacitiy of muscles becomes much better than before |
for 6 months |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
Final Enrollment numbers achieved (Total)= "10"
Final Enrollment numbers achieved (India)="10" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
07/08/2023 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Cerebral palsy describes a group of permanent disorder of movement and posture causing activity limitation resulting from non progressive structural abnormalities in the developing brain. the motor disorder of cerebral palsy are often accompanied by Communication, vision, perception, sensation, behavior, seizure disorder and secondary by disturbances of cognition. In ayurveda there are Various Methods in Panchkarma like Snehana, Swedana, Basti. For CP patient We will give Chaturabhadra Kalpa basti (i.e. 4 Anuvasan basti Followed by 4 Niruha and 4 Anuvasan basti) With Devadaru Baladi Tail and Devadaru Baladi Kwath including Devadaru Baladi Churna orally, to find out its effectivness on Diagnosed Cerebral Palsy Patient and to improve the Condition with the intention of minimizing the disability, to improve their quality of life and give them active Self Supporting long life with happiness. A total 6 month ( basti, nasya and abhyang will be done for 12 days and then 18 days of interval in which abhyang at home and pana ( orally) of Devadaru baladi tail with milk will be given, again same procedure will be done for next 6 month). |