| CTRI Number |
CTRI/2024/05/067703 [Registered on: 21/05/2024] Trial Registered Prospectively |
| Last Modified On: |
15/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha
Other (Specify) [THOKKANAM] |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
To study the effect of Siddha formulations Vani vallarai Nei (Internal) and Chitramutti Madakuthylam (External) for Cerebral palsy |
|
Scientific Title of Study
|
Pre-Clinical and Clinical Studies On the management Of Cerebral Palsy (Sirakamba Vatham) in Children Using The Siddha Formulations Vani Vallarai Nei (Internal) and Chitramutti Madakuthylam (External) – A Multi centric study |
| Trial Acronym |
Not Applicable |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr S Shakila |
| Designation |
Full Time PhD scholar, |
| Affiliation |
National Institute of Siddha, |
| Address |
Department of Kuzhanthai Maruthuvam,
National Institute of Siddha,
Tambaram Sanatorium, Chennai- 600 047.
Chennai
TAMIL NADU
600047
India |
| Phone |
9789018413 |
| Fax |
|
| Email |
sakila.sekar19@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S Shakila |
| Designation |
Full Time PhD scholar, |
| Affiliation |
National Institute of Siddha, |
| Address |
Department of Kuzhanthai Maruthuvam,
National Institute of Siddha,
Tambaram Sanatorium, Chennai- 600 047.
TAMIL NADU
600047
India |
| Phone |
9789018413 |
| Fax |
|
| Email |
sakila.sekar19@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S Shakila |
| Designation |
Full Time PhD scholar, |
| Affiliation |
National Institute of Siddha, |
| Address |
Department of Kuzhanthai Maruthuvam,
National Institute of Siddha,
Tambaram Sanatorium, Chennai- 600 047.
TAMIL NADU
600047
India |
| Phone |
9789018413 |
| Fax |
|
| Email |
sakila.sekar19@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Siddha |
|
|
Primary Sponsor
|
| Name |
National Institute of Siddha, |
| Address |
Department of Kuzhanthai Maruthuvam
National Institute of Siddha
Tambaram Sanatorium
Chennai- 600 047
|
| 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 |
| Dr P Arul mozhi |
Ayothidoss Pandithar Hospital attached with National Institute of Siddha |
Room No 17 Department of Kuzhanthai Maruthuvam
National Institute of Siddha
Tambaram Sanatorium Chennai 600 047
Kancheepuram
TAMIL NADU |
9500151930
drarulmozhi2012@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: G804||Ataxic cerebral palsy, (2) ICD-10 Condition: G809||Cerebral palsy, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
physiotherapy |
only for comparison purpose |
| Intervention |
Vani vallarai Nei (Internal) and Chitramutti Madakuthylam (External) |
Dose: 3yrs to 5 yrs - 6 ml , 6yrs to 9yrs - 9 ml , 10yrs to 12 yrs - 11 ml |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosis of Spastic type of cerebral palsy (Sirakamba vadham)
Parents/Guardians giving informed consent (signed witnessed, according to local regulations) before any protocol specific procedures. |
|
| ExclusionCriteria |
| Details |
K/C/O Ataxic/ Dyskinetic /Athetoid/ choreoathetoid / dystonic CP
Mixed type of Cerebral Palsy
CP child with Spinal deformities
ASD/ADHD(Hyper activity)
Blindness, Down Syndrome, Spina Bifida, Traumatic Brain Injury
Severe and/or Multiple Disabilities & Children with H/o bleeding tendencies, cirrhosis and oesophageal Varices
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Safety and efficacy of the trial drug will be analyzed by Preclinical studies.
Improvements in the Clinical conditions will be measured by Assessment scale.
|
90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Intervention efficacy assessed by the Siddha Diagnostic parameter. |
90 days |
|
|
Target Sample Size
|
Total Sample Size="186"
Sample Size from India="186"
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)
|
15/07/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Cerebral palsy places a heavy burden on families and health systems. This is an open-label, non-randomized control study on Cerebral palsy (Sirakamba Vatham) to evaluate the official Siddha formulations Vani Vallarai Nei (internal) and Chitramutti Madakuthylam (external). The children took internal (twice a day) and external (once a day) medicines for 90 days, and improvement will be compared for the control group. The present study will provide a better direction by improving the quality of life of children and their life expectancy. |