| CTRI Number |
CTRI/2020/07/026946 [Registered on: 31/07/2020] Trial Registered Prospectively |
| Last Modified On: |
22/07/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Ayurvedic treatment for Cerebral Palsy |
|
Scientific Title of Study
|
COMPARATIVE CLINICAL ASSESSMENT OF VARIOUS THERAPEUTIC MODALITIES IN THE MANAGEMENT OF SPASTICITY IN 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 SA Nithin |
| Designation |
Professor and Principal |
| Affiliation |
Rajeev Institute of Ayurvedic Medical Science and Research Centre |
| Address |
Rajeev Institute of Ayurvedic Medical Science and Research Centre
BM Bypass road, Hassan
Hassan
KARNATAKA
573201
India |
| Phone |
9845293032 |
| Fax |
|
| Email |
nithinashokkumar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr SA Nithin |
| Designation |
Professor and Principal |
| Affiliation |
Rajeev Institute of Ayurvedic Medical Science and Research Centre |
| Address |
Rajeev Institute of Ayurvedic Medical Science and Research Centre
BM Bypass road, Hassan
KARNATAKA
573201
India |
| Phone |
9845293032 |
| Fax |
|
| Email |
nithinashokkumar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kavya Mohan |
| Designation |
Assistant Professor |
| Affiliation |
Rajeev Institute of Ayurvedic Medical Science and Research Centre |
| Address |
Rajeev Institute of Ayurvedic Medical Science and Research Centre
BM Bypass road, Hassan
Hassan
KARNATAKA
573201
India |
| Phone |
9745727376 |
| Fax |
|
| Email |
kavya.thannickel@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajiv Gandhi University of Health Sciences, Karnataka |
|
|
Primary Sponsor
|
| Name |
Rajeev Institute of Ayurvedic Medical Science and Research Centre |
| Address |
Rajeev Institute of Ayurvedic Medical Science and Research Centre, Hassan |
| Type of Sponsor |
Private 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 |
| Dr SA Nithin |
Rajeev Institute of Ayurvedic Medical Science and Research Centre |
Room No.4, Department of Kaumarabhritya
Hassan
KARNATAKA |
9845293032
nithinashokkumar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Rajeev Institute of Ayurvedic Medical Science and Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G809||Cerebral palsy, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Physical therapy |
Physical therapy |
| Intervention |
Sarvanga Abhyanga and Parisheka |
1] Abyanga with Prasarini Taila for 15 minutes.
2] Dashamoola Kashaya dispensed will be taken in Dharapatra (vessel) and poured continuously, neither too fast nor too slow for about 20-minutes, after completing the procedure body of the patient is wiped out and dried. This is followed by a short duration of rest.
|
| Intervention |
Sarvanga Abhyanga,Nadi sweda and Matra Basti |
1] Abyanga with PrasariniTaila for 15 minutes.
2] Nadi sweda with Dashamoola kashaya
3] Matra Basti wit Samvardhanaghrita (dose as per age)
|
| Intervention |
Sarvanga Abhyanga,Nadisweda and Upanaha |
1] Abyanga with PrasariniTaila for 15 minutes.
2] Nadisweda with Dahamoolakashaya
3] Followed by application of Upanaha(Kolakulathadichurna, Godhuma and Bala (SidacordifoliaL.)churna).
|
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
1) Children in the age group of 3-8 years of both gender
2) Children whose parents are willing to sign the informed assent form
3) If participant history of epilepsy,well controlled by medication
|
|
| ExclusionCriteria |
| Details |
1)Mixedvariety of cerebral palsy.
2)Children with infectious diseases like tuberculosis, meningitis
3)Children with poor controlled epilepsy,recurrent status epilepticus, intractable seizures, complex seizures, juvenile diabetes mellitus,severe cognitive impairment.
4) With Severe motor handicap and deformities from long standing spasticity.
5) 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
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Compare the effectiveness of various treatment modalities in the management of spasticity in children with Cerebral Palsy |
180 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Efficacy of therapy and patient well being |
180 days |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
01/04/2021 |
| 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="2"
Months="0"
Days="0" |
|
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 and compare the effectiveness of various treatment modalities in the management of Spasticity in children with Cerebral Palsy. Patients who are fulfilling the criteria for diagnosis and inclusion will be selected for the study. The primary purpose is to compare the effectiveness of various treatment modalities in the management of spasticity in children with Cerebral Palsy while the end point is to appreciate the efficacy of therapy and patient well being. The clinical study will be single centered, open labelled, four arm prospective clinical trial, planned to be conducted in tertiary care teaching hospital attached to Ayurveda Medical college located in district head quarters. The study will be carried out and completed in 2 years duration. 80 patients will be selected successively from the out patient department of Kaumarabhritya of the hospital. |