| CTRI Number |
CTRI/2025/09/094474 [Registered on: 09/09/2025] Trial Registered Prospectively |
| Last Modified On: |
09/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of homoeopathic medicines in the treatment of Global Developmental Delay in children under 5 years of age |
|
Scientific Title of Study
|
Effect of Predefined Medicines of Calcarea Group in the Management of Global Developmental Delay in Children Under 5 years A Single Arm Prospective Clinical Study |
| Trial Acronym |
NIl |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Not Applicable |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Preksha Gautam |
| Designation |
PG Scholar |
| Affiliation |
Bakson Homoeopathic Medical College and Hospital36 B Knowledege Park 1 Greater Noida |
| Address |
Room No G20
Department of Paediatrics
Ground floor
Plot no 36B Knowledge Park Phase 1
Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201306
India |
| Phone |
8290750172 |
| Fax |
|
| Email |
prekshagautam97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ritu Gontiya |
| Designation |
Associate Professor of Department of Paediatrics |
| Affiliation |
Bakson Homoeopathic Medical College and Hospital |
| Address |
Room No G20
Department of Paediatrics
Ground floor
Plot No 36B Knowledge Park
Phase 1
Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201306
India |
| Phone |
9999407479 |
| Fax |
|
| Email |
drritugontiya1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Puneet Garg |
| Designation |
Professor and HOD |
| Affiliation |
Bakson Homoeopathic Medical College and Hospital |
| Address |
Room No G20
Department of Paediatrics
Ground floor
Plot No 36B Knowledge Park
Phase 1
Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201306
India |
| Phone |
9411437669 |
| Fax |
|
| Email |
drpuneetgarg18@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Bakson Homoeopathic Medical College and Hospital
Room No G22
Principal Office
Ground Floor
Plot no 36B Knowledge Park
Phase 1
Greater Noida
Uttar Pradesh 201306 |
|
|
Primary Sponsor
|
| Name |
Bakson Homoeopathic Medical College and Hospital |
| Address |
Bakson Homoeopathic Medical College and Hospital
Room No G22
Principal Office
Ground Floor Plot no 36B Knowledge Park Phase 1
Greater Noida
Uttar Pradesh 201306 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
Not Applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Preksha Gautam |
Bakson Homoeopathic Medical College and Hospital |
Out Patient Department
Room no 1
Ground Floor
Plot No 36B Knowledge Park Phase 1
Greater Noida
Uttar Pradesh 201306
Gautam Buddha Nagar
UTTAR PRADESH |
8290750172
prekshagautam97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Bakson Homoeopathic Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F88||Other disorders of psychological development, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathic Medicine |
Oral route of administration
Pill Form
30 pill size
Centesimal scale
One dose after initial case taking
Repetition of dose according to follow ups which will be every 4 weeks. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
Children under the age of 5 years irrespective of their gender diagnosed with Global Developmental Delay regardless of race caste religion or socioeconomic status
Children diagnosed with Global Developmental Delay irrespective of having any other comorbidities.
|
|
| ExclusionCriteria |
| Details |
Children who are severely ill and require hospitalization
Children with profound GDD SQ below 20
Children with uncontrolled or unstable psychiatric conditions that could affect participation in the study
Children with severe or profound sensory and motor impairments e g total blindness or deafness that would impede the ability to participate in the study interventions or assessments
Children who are currently involved in other clinical trials or interventions that might bias the outcomes of this study
Children whose parents or guardians are unable to provide written informed consent or who do not comply with study requirements
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessing the Effect of Predefined Medicines of Calcarea group in the Management of Global Developmental Delay in Children Under 5 years using Vineland Social Maturity Scale |
16 Months Study
6 Months Enrollment
6 Months Follow up
2 Months Assessment and Data Analysis
2 Months Report Writing
Scale to be assessed at baseline at 3 Month and at 6 Month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL
|
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
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)
|
20/09/2025 |
| 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="4"
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 Study aims to assess the effect of Predefined Medicines of Calcarea group in the management of Global Developmental Delay in children under 5 years of age in which 35 cases will be enrolled irrespective of gender and comorbidities and changes will be recorded using Vineland Social Maturity Scale and the commonly indicated medicine among predefined medicines of Calcarea group will be identified at the end of the treatment For statistical analysis Repeated Measure ANOVA will be used at baseline 3 month and 6 month |