| CTRI Number |
CTRI/2025/12/099769 [Registered on: 23/12/2025] Trial Registered Prospectively |
| Last Modified On: |
06/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A Study to Understand the Effect of Homoeopathy on Children with Cerebral Palsy |
|
Scientific Title of Study
|
RANDOMIZED CONTROL STUDY TO SEE THE EFFECTIVENESS OF INDIVIDUALIZED HOMOEOPATHY TREATMENT ON CEREBRAL PALSY AMONG 3 TO 15 AGE GROUP 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 |
Neha chauhan |
| Designation |
PG SCHOLAR |
| Affiliation |
SRI GANGANAGAR HOMOEOPATHIC MEDICAL COLLEGE ,HOSPITAL AND RESEARCH INSTITUTE |
| Address |
Department of Pediatric Ground floor PG block near ricco bus stand Sriganganagar
Ganganagar
Rajasthan
335002
India
Ganganagar
RAJASTHAN
335002
India |
| Phone |
08527092697 |
| Fax |
|
| Email |
nehachauhan4aug@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Amritpal singh |
| Designation |
Associate professor |
| Affiliation |
SRI GANGANAGAR HOMOEOPATHIC MEDICAL COLLEGE ,HOSPITAL AND RESEARCH INSTITUTE |
| Address |
Department of Pediatric Ground floor PG block near ricco bus stand Sriganganagar
Ganganagar
Rajasthan
335002
India
Ganganagar
RAJASTHAN
335002
India |
| Phone |
9914930022 |
| Fax |
|
| Email |
docamritpalsinghmd@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Neha chauhan |
| Designation |
PG SCHOLAR |
| Affiliation |
SRI GANGANAGAR HOMOEOPATHIC MEDICAL COLLEGE ,HOSPITAL AND RESEARCH INSTITUTE |
| Address |
Department of Pediatric Ground floor PG block near ricco bus stand Sriganganagar
Ganganagar
Rajasthan
335002
India
Ganganagar
RAJASTHAN
335002
India |
| Phone |
08527092697 |
| Fax |
|
| Email |
nehachauhan4aug@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
SRI GANGANAGAR HOMOEOPATHIC MEDICAL COLLEGE ,HOSPITAL AND RESEARCH INSTITUTE |
| Address |
Near Ricco Bus Stand ,Hanumangarh road, Sriganganagar, Rajasthan (335002) |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| NEHA CHAUHAN |
SRI GANGANAGAR HOMOEOPATHIC MEDICAL COLLEGE HOSPITAL AND RESEARCH INSTITUTE |
ROOM NO 102,PEDIATRIC OPD SRIGANGANAGAR HOMOEOPATHIC MEDICAL COLLEGE HOSPITAL AND RESEARCH INSTITUTE,NEAR RIICO BUS STAND HANUMANGARH ROAD,SRIGANGANAGAR,RAJASTHAN
Ganganagar
RAJASTHAN |
8527092697
nehachauhan4aug@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Sri Ganganagar Homoeopathic College Hospital and Research Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G809||Cerebral palsy, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized Homoeopathic Treatment |
The remedy will be chosen based on each childs individual symptoms,constitution and clinical characteristics.
Administered orally as per classical homoeopathic prescription |
| Comparator Agent |
Placebo |
Administered 5 globules once daily for 6 months |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
1.Clinically diagnosed cases of Cerebral Palsy (any type spastic, dyskinetic, ataxic, or mixed).
2.Age group between 3 to 15 years.
3.Both genders will be included.
4.Parents willing to provide informed consent and comply with follow-up visits.
5.Children receiving regular physiotherapy or rehabilitation (to ensure standard baseline care).
6.Children with stable neurological status (no acute deterioration in the last 3 months).
|
|
| ExclusionCriteria |
| Details |
1.Children suffering from progressive neurological or degenerative disorders (e.g., muscular dystrophy).
2.Presence of severe intellectual disability or uncontrolled epilepsy interfering with assessment.
3.Children with genetic or chromosomal syndromes (e.g., Down’s syndrome).
4.Children currently undergoing other alternative systems of treatment (Ayurveda, Unani, etc.).
5.Acute medical illnesses or infections at the time of enrollment.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean change in Gross Motor Function Measure total score from baseline to 6 months after randomization |
Mean change in Gross Motor Function Measure total score from baseline to 6 months after randomization |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
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
|
N/A |
|
Date of First Enrollment (India)
|
25/12/2025 |
| 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="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 is one of the most common cause of physical disability in childhood resulting from a non progressive lesion or abnormality of developing brain AIM: To assess the effectiveness of individualized homoeopathic treatment in improving functional abilities among children with cerebral palsy OBJECTIVES: To explore a group of most effective Homoeopathic medicines in the treatment of cerebral palsy To determine the frequently used potency in the treatment of C.P. To identify the predominant miasm in the cases of cerebral palsy |