| CTRI Number |
CTRI/2026/01/102468 [Registered on: 29/01/2026] Trial Registered Prospectively |
| Last Modified On: |
29/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Homeopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of exposure therapy alone and exposure therapy combined with individualized homoeopathic medicines in patients with social anxiety. |
|
Scientific Title of Study
|
Efficacy of Individualized Homoeopathic Medicine With Exposure Therapy Versus Exposure Therapy alone in Social Anxiety Disorder using Liebowitz Social Anxiety Scale A Double Blind Randomized Controlled Trial |
| 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 Godula Sai Chandana Reddy |
| Designation |
PG Scholar |
| Affiliation |
JIMS Homoeopathic Medical College And Hospital |
| Address |
OPD 201 Department Of Psychiatry JIMS Homoeopathic Medical College And Hopsital Sriramnagar Muchintal Village Palamakul PO Hyderabad Telangana
Hyderabad TELANGANA 509325 India |
| Phone |
6281980340 |
| Fax |
04023470444 |
| Email |
godulachandana@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr V Sravani |
| Designation |
MD Homoeopathic Psychiatry Assistant Professor |
| Affiliation |
JIMS Homoeopathic Medical College And Hospital |
| Address |
OPD 201 Department Of Psychiatry JIMS Homoeopathic Medical College And Hopsital Sriramnagar Muchintal Village Palamakul PO Hyderabad Telangana
Hyderabad TELANGANA 509325 India |
| Phone |
8801213553 |
| Fax |
04023470444 |
| Email |
v.sravani54@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Godula Sai Chandana Reddy |
| Designation |
PG Scholar |
| Affiliation |
JIMS Homoeopathic Medical College And Hospital |
| Address |
OPD 201 Department Of Psychiatry JIMS Homoeopathic Medical College And Hopsital Sriramnagar Muchintal Village Palamakul PO Hyderabad Telangana
Hyderabad TELANGANA 509325 India |
| Phone |
6281980340 |
| Fax |
04023470444 |
| Email |
godulachandana@gmail.com |
|
|
Source of Monetary or Material Support
|
| JIMS Homoeopathic Medical College And Hospital |
|
|
Primary Sponsor
|
| Name |
JIMS Homoeopathic Medical College And Hospital |
| Address |
JIMS Homoeopathic Medical College And Hospital Sriramnagra Muchintal village Palamakul PO Telangana 509325 INDIA |
| 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 Godula Sai Chandana Reddy |
JIMS Homoeopathic Medical College And Hopsital |
OPD 201 Department Of Psychiatry JIMS Homoeopathic Medical College And Hopsital Sriramnagar Muchintal Village Palamakul PO Hyderabad Telangana Hyderabad TELANGANA |
6281980340 04023470444 godulachandana@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JIMS Homoeopathic Medical College And Hospital |
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 |
| Comparator Agent |
Exposure Therapy |
Exposure therapy will be given in sessions every 21 days |
| Intervention |
Individualized Homoeopathic Medicine With Exposure Therapy |
Medicines will be prescribed based on the similimum in either powder or pills form given every 21 days along with exposure therapy |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Age group of 18-45 years
Patients fulfilling the Liebowitz social anxiety scale till moderate score 50-64
Patients fulfilling the diagnostic criteria for social anxiety disorder in Diagnostic and
Statistical Manual of Mental Diseases 5th edition |
|
| ExclusionCriteria |
| Details |
Participants who are under allopathic treatment for social anxiety disorder
Subjects diagnosed with autism spectrum disorder
Subjects with other co morbid anxiety disorder like panic disorder major depressive
disorder |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
significant reduction in the scores of Liebowitz social anxiety scale in the group receiving individualized homoeopathic medicine along with
exposure therapy compared to the group receiving exposure therapy at the end of 6 months |
End of 6 Months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="75" Sample Size from India="75"
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 2 |
|
Date of First Enrollment (India)
|
10/02/2026 |
| 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
|
Social Anxiety Disorder SAD is a common chronic anxiety disorder characterized by an intense fear of social scrutiny negative evaluation and avoidance of social situations often beginning in adolescence and leading to significant functional impairment Despite the availability of effective psychological interventions such as exposure therapy many individuals continue to experience residual symptoms highlighting the need for complementary approaches Homoeopathy with its individualized and holistic treatment principles has shown potential benefits in managing anxiety disorders though robust controlled evidence in SAD is limited
The present study aims to compare the efficacy of individualized homoeopathic medicine combined with exposure therapy versus exposure therapy alone in patients diagnosed with Social Anxiety Disorder This study is designed as a double blind randomized controlled trial involving 75 participants aged 18–45 years with mild to moderate SAD Participants will be randomly allocated into two groups Group A receiving individualized homoeopathic treatment along with exposure therapy and Group B receiving exposure therapy alone over a period of six months Symptom severity and treatment response will be assessed using the Liebowitz Social Anxiety Scale LSAS at baseline and during monthly follow ups The findings of this study may contribute valuable evidence regarding the role of individualized homoeopathy as an adjunct to exposure therapy in the comprehensive management of Social Anxiety Disorder |