| CTRI Number |
CTRI/2025/08/092928 [Registered on: 12/08/2025] Trial Registered Prospectively |
| Last Modified On: |
12/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study on how Homoeopathy can help children with social anxiety |
|
Scientific Title of Study
|
A Clinical Study on the role of Homoeopathic medicine for managing Social Anxiety Disorder in the Paediatric population |
| 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 Jeyapreethi B |
| Designation |
Post Graduate Student |
| Affiliation |
Sarada Krishna Homoeopathic Medical College |
| Address |
Room No 409, third floor, college building, Sarada Krishna Homoeopathic Medical College, Kulasekharam, Kanniyakumari,Tamil Nadu
Kanniyakumari
TAMIL NADU
629161
India |
| Phone |
9444322193 |
| Fax |
|
| Email |
jeyapreethi04@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr D Bencitha Horrence Mary |
| Designation |
Associate Professor |
| Affiliation |
Sarada Krishna Homoeopathic Medical College |
| Address |
Room No 409, third floor, college building, Sarada Krishna Homoeopathic Medical College, Kulasekharam, Kanniyakumari, Tamil Nadu
Kanniyakumari
TAMIL NADU
629161
India |
| Phone |
9443064215 |
| Fax |
|
| Email |
dr.bencitha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr D Bencitha Horrence Mary |
| Designation |
Associate Professor |
| Affiliation |
Sarada Krishna Homoeopathic Medical College |
| Address |
Room No 409, third floor, college building, Sarada Krishna Homoeopathic Medical College, Kulasekharam, Kanniyakumari, Tamil Nadu
Kanniyakumari
TAMIL NADU
629161
India |
| Phone |
9443064215 |
| Fax |
|
| Email |
dr.bencitha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institution - Sarada Krishna Homoeopathic Medical College, Kulasekharam, Tamil Nadu - 629161 |
|
|
Primary Sponsor
|
| Name |
Post graduate research funded by the college |
| Address |
Sarada Krishna Homoeopathic Medical college, Kulasekharm, Kanniyakumari, Tamil Nadu, India 629161 |
| 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 Jeyapreethi B |
Sarada Krishna Homoeopathic Medical College |
108, Department of Paediatrics, Sarada Krishna Homoeopathic Medical College and Hospital, Kulasekharam, Kanniyakumari, Tamil Nadu 629161
Kanniyakumari
TAMIL NADU |
9444322193
jeyapreethi04@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution Ethics Committee Sarada Krishna Homoeopathic Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F401||Social phobias, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized Homoeopathic Medicine |
Medicines will be selected through proper case taking and repertorization and its administration according to Homoeopathic principles.
Dose - homoeopathic medicines will be administered according to the susceptibility of
the patient starting from 30th potency.
Repetition of medicine will be decided based on the improvement of the patient. Intervention will be assesssed after 3 months
Duration of the study is 1 year
|
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Children of both sex
Children fulfilling ICD -10 criteria for Social Anxiety Disorder. |
|
| ExclusionCriteria |
| Details |
Children with mental retardation, specific learning disability, ADHD, depression, or
psychosis, severe intellectual disabilities etc.
Children with hearing or visual defects and with physical illness.
Children with comorbid psychiatric disorders requiring urgent psychiatric intervention.
Patients taking medicines for any other chronic illness. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Significant reduction in the severity of social anxiety symptoms in children after administration of individualized homeopathic medicine.
|
1 year
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Identification of probable causes or triggers of social anxiety in paediatric cases.
To compare the usefulness of the Social Anxiety Questionnaire for Children and the Liebowitz Social Anxiety Scale in assessing the severity of anxiety and the response to treatment in children |
1 year |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
30/08/2025 |
| 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 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 clinical study aims to evaluate the effectiveness of individualized homoeopathic medicine in managing Social Anxiety Disorder among the paediatric population aged 6 to 18 years. A total of 34 children fulfilling the International Classification of Disease -10 diagnostic criteria for Social Anxiety Disorder will be selected through purposive sampling from the Outpatient Department, In patient Department, rural health centers, and school health programs of Sarada Krishna Homoeopathic Medical College. The study will be assessed with pre- and post-intervention assessments using the Social Anxiety Questionnaire for Children and Liebowitz Social Anxiety Scale to measure the severity of social anxiety. Individualized homoeopathic remedies will be prescribed based on detailed case taking, symptom totality, and repertorization, with follow-up over a period of 6 months to 1 year. The primary outcome is a significant reduction in social anxiety symptoms post-treatment, and secondary outcomes include evaluation of the probable causes of Social Anxiety Disorder in children and comparison of the applicability of both the scales. The study is expected to provide clinical evidence for the role of homoeopathy as a safe and holistic approach in the management of paediatric social anxiety |