| CTRI Number |
CTRI/2025/01/079497 [Registered on: 27/01/2025] Trial Registered Prospectively |
| Last Modified On: |
06/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha
Other (Specify) [MASSAGE] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Management of CEREBRAL PALSY (SIRAKKAMBAVATHAM) with KODIVELI CHOORANAM as internal medicine and SEERAGA THAILAM as external medicine. |
|
Scientific Title of Study
|
Preclinical and Clinical evaluation of the effect of KODIVELI CHOORANAM (INTERNAL) along with SEERAGA THAILAM (EXTERNAL) in the management of SIRAKKAMBAVATHAM (CEREBRAL PALSY) in Children. |
| 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 KAVYADHARSHINI M |
| Designation |
PG Scholar |
| Affiliation |
Government siddha medical college,Palayamkottai,Tirunelveli. |
| Address |
Department of Kuzhanthai Maruthuvam,Government siddha medical college and Hospital,Palayamkottai.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
8870505814 |
| Fax |
|
| Email |
drkavyadharshinibsms@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR A ANBUMALAR MDS |
| Designation |
Lecturer |
| Affiliation |
Government siddha medical college, Palayamkottai,Tirunelveli. |
| Address |
Department of Kuzhanthai Maruthuvam,Government siddha medical college and Hospital,Palayamkottai.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9788232433 |
| Fax |
|
| Email |
anbumalara@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR A ANBUMALAR MDS |
| Designation |
Lecturer |
| Affiliation |
Government siddha medical college, Palayamkottai,Tirunelveli. |
| Address |
Department of Kuzhanthai Maruthuvam,Government siddha medical college and Hospital,Palayamkottai.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9788232433 |
| Fax |
|
| Email |
anbumalara@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government siddha medical college and hospital, Palayamkottai, Tirunelveli.627002.Tamilnadu,India. |
|
|
Primary Sponsor
|
| Name |
DR KAVYADHARSHINI M |
| Address |
First year PG Scholar, Department of Kuzhanthai Maruthuvam, Government siddha medical college and hospital, Palayamkottai. |
| Type of Sponsor |
Other [Self] |
|
|
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 A ANBUMALAR MD S |
Government Siddha Medical College and hospital, Palayamkottai. |
Department of Kuzhanthai Maruthuvam,
Government Siddha Medical College and hospital, Palayamkottai.
Tirunelveli
TAMIL NADU |
9788232433
anbumalara@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Government siddha medical college, Palayamkottai, Tirunelveli.627002,Tamilnadu,India. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G800||Spastic quadriplegic cerebral palsy, (2) ICD-10 Condition: G801||Spastic diplegic cerebral palsy, (3) ICD-10 Condition: G802||Spastic hemiplegic cerebral palsy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
KODIVELI CHOORANAM (Internal Administration) and SEERAGA THAILAM (External Application) |
KODIVELI CHOORANAM Should be administered orally twice a day after food. Dosage(according to the age of the patient) 200 to 500MG. Duration-48 days.
SEERAGA THAILAM should be applied externally for massage once a day. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Delay in gross motor and fine motor milestones.
Intellectual and cognitive functions development delay.
Abnormal muscle tone and reflexes.
Stiff and weak muscles.
Spastic type cerebral palsy. |
|
| ExclusionCriteria |
| Details |
Status epilepticus
Cerebral palsy with other associated congenital disorders
Ataxic type cerebral palsy
Dyskinetic cerebral palsy
Mixed type cerebral palsy
Autism spectrum disorder
Attention defecit hyperactivity disorder. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome of the study is to evaluate the reduction in the spasticity of muscle and improvement in movements. |
The outcome will be assessed after the treatment of 48 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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)
|
04/02/2025 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 is a non progressive neuromotor disorder of posture and movements. It is the one among the challenging disorders in the paediatric age group. The clinical features of SIRAKKAMBAVATHAM in siddha classical textbook YUGI VAITHIYA SINDHAMANI can be correlated with CEREBRAL PALSY. In classical siddha literature aathmarakshamirtha vaithiya sarasangiragam, A drug which indicates that vatha vaayu and pakkavatham can be managed by internal medicine KODIVELI CHOORANAM along with external medicine SEERAGA THAILAM are indicated for Vatha noi in Sarabenthra vaithiyamuraigal - vatha roga sigitchai.Considering the above explanation I have choosen KODIVELI CHOORANAM and SEERAGA THAILAM for management of Sirakkambavatham (Cerebral palsy).
OBJECTIVE:
The objective of the study is to evaluate the combined effect of KODIVELI CHOORANAM (Internal) and SEERAGA THAILAM ( External) in the management of SIRAKKAMBAVATHAM (CEREBRAL PALSY) in children. |