| CTRI Number |
CTRI/2019/06/019645 [Registered on: 12/06/2019] Trial Registered Prospectively |
| Last Modified On: |
12/06/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Ayurvedic Management of Paralysis in Children |
|
Scientific Title of Study
|
A clinical study on cerebral palsy in children with Balapanchamrita Yoga and Procedure based therapy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Upasana sonker |
| Designation |
PG Scholar |
| Affiliation |
All India Institute of Ayurveda,Sarita Vihar |
| Address |
Kaumarabhritya OPD NO.208 second floor All India Institute of Ayurveda sarita vihar
Academic Block fourth floor All India Institute of Ayurveda sarita vihar
New Delhi
DELHI
new delhi 110076
India |
| Phone |
8851363937 |
| Fax |
0 |
| Email |
drupasanasonker23@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajagopala S |
| Designation |
Associate professor |
| Affiliation |
All India Institute of Ayurveda,Sarita Vihar |
| Address |
Kaumarabhritya OPD NO.208 second floor All India Institute of Ayurveda sarita vihar
Academic Block fourth floor All India Institute of Ayurveda sarita vihar
New Delhi
DELHI
new delhi 110076
India |
| Phone |
7600902564 |
| Fax |
0 |
| Email |
srajagopala@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajagopala S |
| Designation |
Associate professor |
| Affiliation |
All India Institute of Ayurveda,Sarita Vihar |
| Address |
Kaumarabhritya OPD NO.208 second floor All India Institute of Ayurveda sarita vihar
Academic Block fourth floor All India Institute of Ayurveda sarita vihar
New Delhi
DELHI
new delhi 110076
India |
| Phone |
7600902564 |
| Fax |
0 |
| Email |
srajagopala@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Ayurveda sarita vihar new delhi 110076 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Ayurveda |
| Address |
Kaumarabhritya OPD NO.-208 Second floor, All India Institute of Ayurveda
Gautampuri Sarita Vihar
New Delhi
DELHI
110076
India |
| 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 |
| Upasana sonker |
All India Institute of Ayurveda sarita vihar |
Kaumarabhritya OPD NO. 208 secdond floor All India Institute of Ayurveda sarita vihar new delhi 110076
New Delhi
DELHI |
8851363937
0
drupasanasonker23@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G800||Spastic quadriplegic cerebral palsy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Udvartana with Tila Pinyaka Churna Powder of Sesame oil cake,Abhayanga and Matra Basti with
Ksheerabala Taila and Bashpa Swedana with
Eranda Patra Kwatha with Internal
Medication Balapanchamrita Yoga (dose as per age) |
Udvaratana – 3 days,
Sarvanga Abhyanga and
Bashpa swedana -14 days,
Matra basti -7days(8thday of
Sarvanga Abhyanga and
Bashpa Swedana)
+
Balapanchamrita Yoga (Total 3 course of treatment, with an interval of 15 days between each course, One course of treatment will be for 17days) |
| Intervention |
Udvartana with Tila Pinyaka Churna Powder of Sesame oil cake,Abhyanga and Matra Basti with Murcchita
Tila Taila and Bashpa Swedana with simple
water steam with Internal Medication
Balapanchamrita Yoga (dose as per age) |
Udvaratana – 3 days,
Sarvanga Abhyanga and
Bashpa swedana -14 days,
Matra basti -7days(8thday of
Sarvanga Abhyanga and
Bashpa Swedana)
+
Balapanchamrita Yoga (Total 3 course of treatment, with an interval of 15
days between each course,
One course of treatment will be for 17days) |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Age group of 1 to 12 years of either gender
Diagnosed Case of Cerebral palsy
Parents submitting written consent to participate in the study. |
|
| ExclusionCriteria |
| Details |
Progressive neurological disorder,Children suffering from any systemic illness,Children with severe intractable epilepsy as co-morbidity,Acute illness that would interfere with carrying out the interventions, Recent orthopedic surgery/casting/splint,Children had received botox (last 1yr) or had undergone phenol block injection or intrathecal
baclofen medication,Fixed contractures, Congenital disorders like Down’s syndrome, Fragile -X syndrome or any congenital
anomalies,Caregiver not willing to sign the informed consent form. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Response in spasticity and range of motion (ROM) of joints.
Expected outcome will be 17.5%. |
assessment will be made on before treatment and after treatment
[After 02 months of Follow up] |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Response in the quality of life (QOL) |
90 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/07/2019 |
| Date of Study Completion (India) |
20/05/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Publication which arise directly out of this trial results are to be mentioned in peer journals for wider dissemination. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Cerebral palsy is defined as a non-progressive neuromotor disorder of cerebral origin caused by insult or injury to developing brain during its early stage of development . Children affected with the disease present with developmental delay and motor deficits and may have one or more associated problem like mental retardation, seizures, feeding difficulties along with ophthalmologic and hearing impairments. Cerebral Palsy is most common motor disability affecting a large Pediatric population world-wide [2]. According to WHO(World Health Organization) estimation 10% of population has some form of disability due to different causes, in India it is 3.8% of population).Nearly 15-20% of total physical handicapped children are suffering from C.P. World- wide incidence of C.P is 2.5/1000 live births[4] and for India it is 3/1000 live births more than 15 million people worldwide and more than 25 lakh people in India are living with this disability. For CP, there is no any direct reference in Ayurvedic classics.Some conditions are found discrete in classics at different,places like Phakka, Pangulya, Mukatva, Jadatva, Ekanga roga, Sarvanga roga, Pakshaghata, Pakshavadha etc. under the group of Vata Vyadhi which can be compared with the presentation of Cerebral palsy.If Vata is considered as major contributing factor for CP then Vata pacifying measures becomes essential component in the treatment. Treatment of Vata Dosha consists of a variety of treatment modalities like Abhyanga, Swedana and Basti.The total sample size for this clinical trial is required to be 30(15 in each group).The trial will be of 3 months~=Total 3 course of treatment, with an interval of 15 days between each course,One course of treatment will be for 17days [Udvaratana – 3 days Sarvanga Abhyanga and Bashpa swedana -14 days, Matra basti -7days(8thday of Sarvanga Abhyanga and Bashpa Swedana) and oral medicine with Balapanchamrita Yoga]. Group A (Abhayanga and Matra Basti with Ksheerabala Taila and Bashpa Swedana with Eranda Patra Kwatha with Internal Medication Balapanchamrita Yoga) and Group B (Abhyanga and Matra Basti with Murcchita Tila Taila and Bashpa Swedana with simple water steam with Internal Medication Balapanchamrita Yoga) |