| CTRI Number |
CTRI/2019/10/021678 [Registered on: 16/10/2019] Trial Registered Prospectively |
| Last Modified On: |
08/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A trial to study the add on effects of Ayurveda in the treatment of cerebral palsy |
|
Scientific Title of Study
|
Add on Efficacy and Functional outcomes of Combination of Ayurveda therapies along with oral administration of Ashwagandha churnam (a traditional Ayurvedic formulation made up of roots of Withania somnifera (L) Dunal ) in children with Spastic cerebral Palsy: A randomized controlled open label Pilot Study |
| Trial Acronym |
AYUTONE |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gautam Sharma |
| Designation |
Professor In Charge |
| Affiliation |
All India Institute of Medical Sciences (AIIMS) |
| Address |
Center for Integrative Medicine and Research (CIMR)
7th Floor, Convergence Block,
All India Institute of Medical Sciences
New Delhi
South
DELHI
110029
India |
| Phone |
011-26549326 |
| Fax |
|
| Email |
drsharmagautam@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gautam Sharma |
| Designation |
Professor In Charge |
| Affiliation |
All India Institute of Medical Sciences (AIIMS) |
| Address |
Center for Integrative Medicine and Research (CIMR)
7th Floor, Convergence Block,
All India Institute of Medical Sciences
New Delhi
South
DELHI
110029
India |
| Phone |
011-26549326 |
| Fax |
|
| Email |
drsharmagautam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gautam Sharma |
| Designation |
Professor In Charge |
| Affiliation |
All India Institute of Medical Sciences (AIIMS) |
| Address |
Center for Integrative Medicine and Research (CIMR)
7th Floor, Convergence Block,
All India Institute of Medical Sciences
New Delhi
South
DELHI
110029
India |
| Phone |
011-26549326 |
| Fax |
|
| Email |
drsharmagautam@gmail.com |
|
|
Source of Monetary or Material Support
|
| Centre for Excellence Scheme, Ministry of AYUSH, AYUSH Bhawan,B Block,GPO Complex,INA,New Delhi 110023 |
|
|
Primary Sponsor
|
| Name |
Centre for Integrative Medicine and Research CIMR |
| Address |
Centre for Integrative Medicine and Research (CIMR), All India
Institute of Medical Sciences (AIIMS), New Delhi |
| 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 Gautam Sharma |
All India Institute of Medical Sciences (AIIMS) |
Room number 7004,
7th Floor, Centre for
Integrative Medicine
and Research (CIMR),
Convergence Block, All
India Institute of
Medical Sciences
(AIIMS), Ansari Nagar,
New Delhi
South
DELHI |
01126549326
drsharmagautam@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G80||Cerebral palsy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1. Ayurveda therapy (including Udwartana: 21 sessions, Abhyangam: 7 sessions, Kayaseka:14 sessions, Shiropichu: 21 sessions) along with Oral administration of Ashwagandha churnam 2.5- 12.5 gm in two divided doses as per age with honey. The therapy sessions will be spread over in 3 months. Oral administration of ashwagandha churnam will continue for 5 months. The total duration of Intervention is 5 months. (3 months therapy with 2 months follow up).
2. Subjects will also receive standard care as per the protocol followed by Child Neurology division, AIIMS, New Delhi.
|
Study group will receive multiple Ayurveda therapies for 3 months. Details of therapies are Udwartana (application of medicated powder with gentle rub), Abhyangam (application of medicated oil), Shiropichu (application of cotton swab soaked in oil over the site of bregma) and kayaseka (pouring warm medicated oil in a specific manner) with oral administration of Ashwagandha churnam. every month subjects will receive 14 days of pre-defined therapy sessions with resting period of 14 days. After 3 months subjects will be followed upto 2 months. |
| Comparator Agent |
Standard Care only |
The subjects of control group will receive routine care of treatment as per the standard protocol followed by Child Neurology division, AIIMS, New Delhi. |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1. Children diagnosed with Spastic CP
2. Age between 2 and 12 years
3. Both Genders
3. Gross Motor Function Classification System levels II, III, IV&V (Detailed in Annexure- II)
4. Patients/guardian willing to comply with all study related visits and follow instructions as advised by consulting physician
|
|
| ExclusionCriteria |
| Details |
1. Children with Epilepsy
2. Children with fixed Contractures.
3. Children with systemic diseases such as renal or cardiac disorders
4. Any orthopaedic surgery
5. Subjects received botulinum toxin injection in the past 6 months,
6. Serial casting or new orthotics within the past 3 months.
7. Initiating or increasing oral medications that affect the neuromuscular system, e.g. baclofen, diazepam, within the past 3 months.
8. Children who are presently undergoing Modified Constraint Induced Movement Therapy(m-CIMT)
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Spasticity by Modified Ashworth scale |
Baseline,1st month,2nd month, 3rdmonth and 2 months after completion of study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Range of movement (ROM) by goniometry
2.Muscle strength using handheld dynamometer (wherever possible)
3.Gross motor function by GMFCS E&R
4.Cognition and Behaviour by Developmental Profile -3 and Child Behaviour Check List (CBCL)
5.Quality of Life by Ped. QOL inventory
|
Baseline,1st month,2nd month, 3rdmonth and 2 months after completion of study |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
21/10/2019 |
| 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="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Cerebral
palsy (CP) is the most common motor disability in childhood. Among the motor disorders, spasticity is a major
challenge for rehabilitation of children with cerebral palsy. Spasticity can
prevent or hamper function, cause pain, disturb sleep, cause unnecessary
complications and present major difficulties for care workers. There
is an increasing trend in the use of complementary and alternative medicine
worldwide. Combination of Complementary or alternative medicine with the
conventional therapy may help to improve the quality of life in patients with
CP. As per the report of a survey Ayurveda as a part of Complimentary and Alternative
Medicine was used by 7% of the families for their child. Several studies have
been reported in the management of CP using Ayurveda therapies. But these
studies showed a wide range of differences in the selection of treatment
modalities, duration of treatment, outcome measures etc. So current treatment
protocol attempts to explore Multiple Ayurveda treatment modalities including
Udwartana (application of medicated powder with gentle rub), Abyangam
(application of medicated oil), Shiropichu (application of cotton swab soaked
in oil over the site of bregma) and kayaseka (pouring warm medicated oil in a
specific manner) with oral administration of Ashwagandha churnam in children
with Spastic cerebral Palsy.
|