| CTRI Number |
CTRI/2023/10/059262 [Registered on: 30/10/2023] Trial Registered Prospectively |
| Last Modified On: |
27/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A Clinical trial to study the effect of selected Ayurveda procedures & physiotherapy in spastic cerebral palsy |
|
Scientific Title of Study
|
Effectiveness Of Selected Ayurveda Therapeutic Procedures And Physiotherapy In The Management Of Sarvangavata Roga
(Spastic Cerebral Palsy) In Children – A Controlled Clinical Trail |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Suneetha R |
| Designation |
postgraduate Scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital |
| Address |
Department of PG studies in Kaumarabhritya
Sri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Anchepalya, Kumbalgodu post, Bengaluru- 560074
Bangalore
KARNATAKA
560074
India |
| Phone |
8050674912 |
| Fax |
|
| Email |
suneeta.jrk@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Reena K |
| Designation |
Professor and head |
| Affiliation |
Sri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, |
| Address |
Department of PG studies in Kaumarabhritya
Sri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Anchepalya, Kumbalgodu post, Bengaluru- 560074
Bangalore
KARNATAKA
560074
India |
| Phone |
9480478639 |
| Fax |
|
| Email |
drreenakulkarni@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suneetha R |
| Designation |
postgraduate Scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital |
| Address |
Sri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Anchepalya, Kumbalgodu post, Bengaluru- 560074
Bangalore
KARNATAKA
560074
India |
| Phone |
8050674912 |
| Fax |
|
| Email |
suneeta.jrk@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDM Institue of Ayurveda and hospital Anchepalya Kumbalgodu post Bengaluru -74 |
|
|
Primary Sponsor
|
| Name |
Dr Suneetha.R |
| Address |
Department of PG studies in Kaumarabhritya
Sri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Anchepalya, Kumbalgodu post, Bengaluru- 560074 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Suneetha R |
SDM Bengaluru |
Kaumarabhritya opd room number 8
Sri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Anchepalya, Kumbalgodu post, Bengaluru- 560074
Bangalore
KARNATAKA |
8050674912
suneeta.jrk@gmail.com |
| Dr Sanjay Parmar |
SDM Dharwad |
Physiotherapy opd, 1st floor SDM COLLEGE OF PHYSIOTHERAPY
SDM UNIVERSITY
DHARWAD - 580009
Dharwad
KARNATAKA |
9845340450
sanjaytparmar777@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee , Sri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital , Achepalya, Kumbalagodu post, Bengaluru. |
Approved |
| SDM college of Mediccal sciences and hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G809||Cerebral palsy, unspecified. Ayurveda Condition: SARVANGAROGAH/SARVANGAVATAHÂ (KEVALAVATA), (2) ICD-10 Condition:G809||Cerebral palsy, unspecified. Ayurveda Condition: SARVANGAROGAH/SARVANGAVATAHÂ (KEVALAVATA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | physiotherapy | Children in the control group will be administered with guided physiotherapy under the guidance of pediatric physiotherapist for a period of 30 minutes every day over 90days. | | 2 | Intervention Arm | Procedure | - | aBya~ggaH, अà¤à¥à¤¯à¤‚ग | (Procedure Reference: charaka chikistha stana chapter 28, Procedure details: children who are recruited for trial group abyanga will be done with rasa taila for 20 minutes in supine and prone position.)
(1) Medicine Name: rasa taila , Reference: Arogya raksha kalpa druma 24th chapter , Route: Topical, Dosage Form: Taila, Dose: 50(ml), Frequency: od, Duration: 15 Days(2) Medicine Name: dashamoola , Reference: sushruta samhitha , Route: Topical, Dosage Form: Kwatha/Kashaya, Dose: 6000(ml), Frequency: od, Duration: 15 Days(3) Medicine Name: masha godhuma upanaha, Reference: charaka chikista, Route: Topical, Dosage Form: Kalka/ Paste, Dose: 250(g), Frequency: od, Duration: 15 Days |
|
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
1. Children of either gender aged between 2-10years with developmental delay and spasticity or diagnosed cases of spastic cerebral palsy
2. Children whose parents are willing to sign the informed assent
3. Diagnosed case of spastic cerebral palsy with well controlled epilepsy
|
|
| ExclusionCriteria |
| Details |
1. Children with uncontrolled seizure disorders
2. Children with severe contractures requiring surgical intervention
3. Children with other form of severe disability like muscular dystrophy, metabolic myopathies, genetic muscular disorders.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in spasticity
Improved range of movement
Imrpoved gross motor function
cerebral palsy quality of life
|
0 week, 4 weeks, 8 weeks,12 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
reduction of drooling
|
reduction of drooling using drooling rating scale
on 0th day & 90th day |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
15/11/2023 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a open label double arm, prospective, controlled clinical trail to evaluate the effectiveness of selected ayurveda therapeutical procedures with physiotherapy in the management of spaticity in cerebral palsy children 0f 2 to 10 years 20 subjects fulfilling inclusion criteria, attending kaumarabhritya outpatient department and in patient department of SDMIAH, Bengaluru will be taken in study group. 20 subjects fulfilling inclusion criteria , attending physiotherapy out patient department of SDM physiotherapy college Dharwad will be controlled group respectively.
for study group - abyanga with rasa taila, parisheka with dasamoola kashaya , basti with rasa taila quantity according to priscribed age, masha godhumdhi upnaha for affected limbs and kati done for 15 days 3 sittings 15 days of gap between each sitting, continue physiotherapy at home as adviced
for control group - paediatric physiotherapist adviced physiotherapy done for 15 days , 3 sittings, 15 days gap in between sitting. continue home phyiotherapy excercises as taught
The primary outcome measures - reduction in spasticity, increase in joint range of motion, improved mile stone will be assessed using modified ashworth scale for spasticity, goniometer for range of motion, ICD - mile stone grading, manual muscle power testing. The secondary outcome measures - improvement of chewing, reduced drooling, improved quality of life , improved activity of daily leaving |