| CTRI Number |
CTRI/2024/12/077817 [Registered on: 09/12/2024] Trial Registered Prospectively |
| Last Modified On: |
28/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Evaluating Homoeopathy for Managing Global Developmental Delay in Children Alongside Standard Therapies |
|
Scientific Title of Study
|
To assess the effectiveness of Individualized Homoeopathic Medicine using Complete Repertory with standard therapies in the management of global developmental delay in children : A Randomized Single-Blind Double-Arm Placebo-Controlled 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 Lalit Kumar Chauhan |
| Designation |
PG Scholar |
| Affiliation |
Bakson Homoeopathic Medical College and Hospital |
| Address |
Department of repertory, Basement, Room no B15, Bakson Homoeopathic Medical College and hospital,Plot no 36B, Phase 1, Greater Noida, Gautam Buddha Nagar, Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
7017021822 |
| Fax |
|
| Email |
lalitrajput1234567@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aditi Goyal |
| Designation |
Guide HOD and Professor |
| Affiliation |
Bakson Homoeopathic Medical College and Hospital |
| Address |
Department of repertory, Basement, Room no B15, Bakson Homoeopathic Medical College and hospital,Plot no 36B, Phase 1, Greater Noida, Gautam Buddha Nagar, Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9910797598 |
| Fax |
|
| Email |
draditigoyal19@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aditi Goyal |
| Designation |
Guide HOD and Professor |
| Affiliation |
Bakson Homoeopathic Medical College and Hospital |
| Address |
Department of repertory, Basement, Room no B15, Bakson Homoeopathic Medical College and hospital,Plot no 36B, Phase 1, Greater Noida, Gautam Buddha Nagar, Uttar Pradesh
UTTAR PRADESH
201310
India |
| Phone |
9910797598 |
| Fax |
|
| Email |
draditigoyal19@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bakson Homoeopathic Medical College and Hospital, Room No G22, Plot no 36 B, Knowledge park, Phase 1, Greater Noida, Gautam Buddha Nagar, Uttar Pradesh, India, Pin Code 201310 |
|
|
Primary Sponsor
|
| Name |
Principal Bakson Homoeopathic Medical College and Hospital |
| Address |
Room No G22
Ground Floor
Bakson Homoeopathic Medical College and Hospital
36 B Knowledge park 1
Greater Noida
Gautam Buddha Nagar
Uttar Pradesh
India
Pin Code 201310 |
| Type of Sponsor |
Private 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 Lalit Kumar Chauhan |
Bakson Homoeopathic Medical College and Hospital |
Outpatient Department(OPD)
Room No 1
Ground Floor
Bakson Homoeopathic Medical College and Hospital
36B Knowledge Park 1
Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH |
7017021822
lalitrajput1234567@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 Potency
First dose after taking the case Subsequent doses after each follow up potency according to the case |
| Comparator Agent |
Placebo |
Oral route of administration Pill form
30 pill size
Emerged with alcohol First dose after taking the case Subsequent doses after each follow up potency according to the case |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
Children under the age of 5 years of both sexes diagnosed with Global Developmental Delay (GDD), regardless of race, caste, religion, or socioeconomic status.
Children who are currently receiving standard therapies, including:
Occupational Therapy
Language Therapy
Speech Therapy
Physiotherapy
Children diagnosed with Global development delay along with other co-morbidities like:
Autism Spectrum Disorder (ASD)
Cerebral Palsy (CP)
Attention-Deficit/Hyperactivity Disorder (ADHD)
Down Syndrome
Turner Syndrome
Klinefelter Syndrome |
|
| ExclusionCriteria |
| Details |
Children with severe chronic physical disorders that might interfere with the assessment of GDD.
Children who are severely ill and require hospitalization.
Children with profound global developmental delay (SQ Below 20).
Children with uncontrolled or unstable psychiatric conditions and severe neurodevelopmental disorders.
Children with severe or profound sensory impairments (eg total blindness or deafness).
Children who are currently involved in other clinical trials or interventions that might conflict with or 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
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| At the end of this study, it is expected that Complete repertory will be of utility in selection of Homoeopathic similimum in the management of cases of GDD in children. |
15 Months study
6 months Enrolment period
6 months Follow-up
3 months Report writing and Data Analysis
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
10/12/2024 |
| 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 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 is to assess the role of Homoeopathic Medicines in the treatment of Global Developmental Delay Sample Size 70
Randomized, Sigle Blind, Double Arm, Placebo Controlled Clinical Study
15 months study
Scale to be used at baseline, 3rd month and 6th month
|