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CTRI Number  CTRI/2024/12/078190 [Registered on: 16/12/2024] Trial Registered Prospectively
Last Modified On: 11/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   Role of homoeopathic medicine in cerebral palsy in children. 
Scientific Title of Study   Assessing The Effectiveness of LM Potency in the Management of Spastic Cerebral Palsy in Children: A Pre & Post Intervention Clinical Study. 
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 Rahul Kumar Chauhan 
Designation  PG Scholar 
Affiliation  Bakson Homoeopathic Medical College 
Address  Department of Practice of Medicine Basement floor Room No 16 Bakson Homoeopathic Medical college & hospital B 36 Knowledge park I Greater Noida

Gautam Buddha Nagar
UTTAR PRADESH
201310
India 
Phone  8518807604  
Fax    
Email  rahulmedi91@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Man Mohan Chamoli 
Designation  Guide & Assistant Professor 
Affiliation  Bakson Homoeopathic Medical College 
Address  Department of Practice of Medicine Basement floor Room No 16 Bakson Homoeopathic Medical college & hospital B 36 Knowledge park I Greater Noida

Gautam Buddha Nagar
UTTAR PRADESH
201310
India 
Phone  7838034913  
Fax    
Email  manu0001sm@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Akshay Mathur 
Designation  HOD & Professor 
Affiliation  Bakson Homoeopathic Medical College 
Address  Department of Practice of Medicine Basement floor Room No 16 Bakson Homoeopathic Medical college & hospital B 36 Knowledge park I Greater Noida

Gautam Buddha Nagar
UTTAR PRADESH
201310
India 
Phone  9868121727  
Fax    
Email  drakshaymathur@gmail.com  
 
Source of Monetary or Material Support  
Bakson Homoeopathic Medical College and Hospital 36 B Knowledge park 1 Greater Noida Goutam Buddha Nagar UP India pin code 201310 
 
Primary Sponsor  
Name  Bakson Homoeopathic Medical College and Hospital 
Address  Principal Office Bakson Homoeopathic Medical College And Hospital and hospital Ground floor room no G22 B 36 Knowledge park 1 Greater Noida Goutam Buddha Nagar UP India pin code 201310 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rahul Kumar Chauhan  Bakson Homoeopathic Medical College and hospital  out patient department (OPD) bakson homoeopathic medical college and hospital ground floor room no 1 B 36 knowledge park 1
Gautam Buddha Nagar
UTTAR PRADESH 		 8518807604

rahulmedi91@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Bakson Institutional Ethical commitee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G800||Spastic quadriplegic cerebral palsy,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Homoeopathic in LM Potency  Oral Route Of Administration liquid form (water as vehicle), one poppy size globule of desired potency will be dissolved in 120 ml of distilled water, 1 teaspoon is added in a cup of water is to be considered as 1st dose given after case taking repetion is based on susceptibility and follow up of the patient at regular interval of 1 month  
Comparator Agent  not applicable  not applicable 
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  Children from both sexes up to the age group of 04 to 12 years
Mild to moderate spastic CP with speech and social developmental delay
Participants/ guardian who are willing to give assent/consent for the study
 
 
ExclusionCriteria 
Details  Exclusion criteria on severe physical disabilities, genetic disorders like Down syndrome, convulsion and sensory disorders like blindness and deafness
Children suffering simultaneously from other chronic infections (eg MDR tuberculosis or HIV disease)
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Changes will be observed in MAS GMFM and CPQOL.
Changes can be positive or negative or no change. 		 15 months
Enrollments-6 months
Follow up- 6 months
Statistical analysis- 3 months
First dose will be given after case taking.
subsequent doses as per the follow ups.
MAS, GMFM and CPQOL will be used at baseline 3 months and 6 months. 
 
Secondary Outcome  
Outcome  TimePoints 
N/A  N/A 
 
Target Sample Size   Total Sample Size="33"
Sample Size from India="33" 
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)   27/12/2024 
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="3"
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 is a single blind  clinical study  by using the indivisualized  homoeopathic treatment in LM potency in the management of  spastic cerebral palsy. the primary outcome is to assess the change in MAS, GMFM, and CPQOL scale at baseline 3rd month and 6th months and the result will be concluded accordingly. 
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