| CTRI Number |
CTRI/2024/06/069667 [Registered on: 28/06/2024] Trial Registered Prospectively |
| Last Modified On: |
27/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha
Screening
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study for Cerebral Palsy Using Siddha Medicine |
|
Scientific Title of Study
|
Phase II Non Randomized Clinical Study In The Management Of Sirakambavatham (Cerebral Palsy) With The Validation Of Siddha Trial Drug Sirakambavathathirkku Kudineer As Internal Medicine And Saranai Thailam As External Therapy |
| 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 M Kamali |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha Medical College Arumbakkam Chennai 106 |
| Address |
Post graduate room no 25
Department of Kuzhanthai Maruthuvam
Government Siddha Medical College
Arumbakkam
Chennai
TAMILNADU
600106
India
Chennai
TAMIL NADU
106
India |
| Phone |
9585011530 |
| Fax |
|
| Email |
kamalimuthukumarasamy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr N Manju Hemamalini |
| Designation |
Lecturer |
| Affiliation |
Government Siddha Medical College Arumbakkam Chennai 106 |
| Address |
Post graduate room no 25
Department of Kuzhanthai Maruthuvam
Government Siddha Medical College
Arumbakkam
Chennai
TAMILNADU
600106
India
Chennai
TAMIL NADU
106
India |
| Phone |
9894325360 |
| Fax |
|
| Email |
mahema.siddha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr N Manju Hemamalini |
| Designation |
Lecturer |
| Affiliation |
Government Siddha Medical College Arumbakkam Chennai 106 |
| Address |
Post graduate room no 25
Department of Kuzhanthai Maruthuvam
Government Siddha Medical College
Arumbakkam
Chennai
TAMILNADU
600106
India
TAMIL NADU
106
India |
| Phone |
9894325360 |
| Fax |
|
| Email |
mahema.siddha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Siddha Medical College,no.6 Anna Arch road
Arumbakkam
Chennai -600106 |
|
|
Primary Sponsor
|
| Name |
Government Siddha Medical College |
| Address |
No.6 Anna Arch Road
NSK Nagar
Arumbakkam
Chennai-600106 |
| 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 M Kamali |
Government Siddha Medical College |
Room no 25
Department of Kuzhanthai Maruthuvam
Arignar Anna Government Hospital
NSK Nagar
Arumbakkam
Chennai-600106
TAMILNADU
Chennai
TAMIL NADU |
9585011530
kamalimuthukumarasamy@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: M958||Other specified acquired deformities of musculoskeletal system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Sirakambavathathirkku Kudineer (Internal medicine) and Saranai Thailam (external therapy) |
Sirakambavathathirkku Kudineer (Internal medicine) 5-10 ml twice a day for 60 days and Saranai Thailam (external therapy) thokkanam for 60 days |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Delay in gross motor and fine motor milestones
Delay in intellectual and cognitive functional development
Abnormal muscle tone and reflexes
spastic cerebral palsy |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| It is mainly assessed by reduction in clinical symptoms |
60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| It is assessed by comparing the sensory functions connecting parameters and fine motor functions of the upper limb |
60 days |
|
|
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 |
|
Date of First Enrollment (India)
|
03/10/2024 |
| 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
|
This is a single Non-Randomized Open Clinical Trial to study the safety and efficacy of siddha trial drug Sirakambavathathirkku Kudineer (internal medicine) is to be given about 5-10 ml twice a day for 60 days and External therapy of Saranai Thailam (thokkanam) on the affected area for 60 days.Clinical Trail conducted after conducting Pre clinical study. The trial drug Sirakambavathathirkku kudineer is mentioned in Agathiyar Vaithiya Sinthamani and External therapy saranai thailam (Thokkanam) is mentioned in Agathiyar Vaithiya Pooranam 205.During the study related data will be recorded and documented .After the completion of the trial all the data will be statistically analyzed.
|