| CTRI Number |
CTRI/2026/03/105419 [Registered on: 05/03/2026] Trial Registered Prospectively |
| Last Modified On: |
05/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study on How Homoeopathic Treatment Can Help Young People of 18–29 Years Who Feel Very Anxious in Social Situations |
|
Scientific Title of Study
|
TO ASSESS THE ROLE OF HOMOEOPATHIC REMEDIES IN THE MANAGEMENT OF SOCIAL ANXIETY DISORDER IN THE AGE GROUP OF 18-29 YEARS USING SCALE-D SCALE |
| 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 Gandla Maldhakal Pavithra |
| Designation |
PG Scholar |
| Affiliation |
Bharatesh Homoeopathic Medical College and Hospital Sy No 16 |
| Address |
OPD No 01 and IPD Department of Homoeopathic Materia Medica Bharatesh Homoeopathic Medical
College and Hospital Sy No 16 Basavan Kudachi Extension Shindoli
Road Belagavi
Belgaum
KARNATAKA
591124
India
Belgaum KARNATAKA 591124 India |
| Phone |
8105416839 |
| Fax |
|
| Email |
pavitragmygr@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Deepa S Varoor |
| Designation |
Professor |
| Affiliation |
Bharatesh Homoeopathic Medical College and Hospital Sy No 16 |
| Address |
OPD No 01 and IPD Department of Homoeopathic Materia Medica Bharatesh Homoeopathic Medical
College and Hospital Sy No 16 Basavan Kudachi Extension Shindoli
Road Belagavi
Belgaum
KARNATAKA
591124
India
Belgaum KARNATAKA 591124 India |
| Phone |
9341019565 |
| Fax |
|
| Email |
deepavaroor@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Deepa S Varoor |
| Designation |
Professor |
| Affiliation |
Bharatesh Homoeopathic Medical College and Hospital Sy No 16 |
| Address |
OPD No 01 and IPD Department of Homoeopathic Materia Medica Bharatesh Homoeopathic Medical
College and Hospital Sy No 16 Basavan Kudachi Extension Shindoli
Road Belagavi
Belgaum
KARNATAKA
591124
India
Belgaum KARNATAKA 591124 India |
| Phone |
9341019565 |
| Fax |
|
| Email |
deepavaroor@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bharatesh Homoeopathic Medical College & Hospital Sy No 16 Basavan Kudachi Extension
Shindoli Road Belagavi - 591124 |
|
|
Primary Sponsor
|
| Name |
Dr Gandla Maldhakal Pavithra |
| Address |
OPD No 01 and IPD Department
Homoeopathic Materia Medica Bharatesh Homoeopathic Medical
College & Hospital Sy No 16 Basavan Kudachi Extension Shindoli
Road Belagavi
Belgaum
KARNATAKA
591124
India |
| Type of Sponsor |
Other [self] |
|
|
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 Gandla Maldhakal Pavithra |
Bharatesh Homoeopathic Medical College & Hospital |
OPD No 01 and IPD Department of Homoeopathic Materia Medica room no 1 Belgaum KARNATAKA |
8105416839
pavitragmygr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bharatesh Homoeopathic Medical College & 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 |
| Intervention |
Constitutional Medicine |
Constitutional Medicine will be administerd based on the
study subject Constitution
suffering from Social Anxiety Disorder Subjects of young adults aged between 18 to 29 years of both genders irrespective of their socio-economic status |
| Comparator Agent |
not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
29.00 Year(s) |
| Gender |
Both |
| Details |
Subjects of young adults aged between 18 to 29 years of both genders irrespective of their socioeconomic status based on icd 11 6B04 icd 10 F40 10
Subjects who give consent to take part in the study
Subjects of Diagnosed cases of Social Anxiety Disorder and subjects who are full filling the DSM-V criteria
|
|
| ExclusionCriteria |
| Details |
Subjects with history of any substance abuse.
Subjects with corporeal diseases translated into mental diseases.
Subjects having co morbidity with other mental disorders.
Subjects who are on any anti-depressant medicines.
Subjects on any hormonal therapy, pregnant or lactating women.
|
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Improved: Improvement of the patient with decrease in frequency and intensity of symptoms with greater or equal to 30 percent reduction in SAD D Scale score from baseline during the period of study.
2.Not improved: No relief of sign and symptoms during the study or the symptoms reoccur by the end of my study period with no changes in the SAD-D scale.
|
once in 15days for first 2 months and later monthly for next 4 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
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)
|
21/03/2026 |
| 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="6" 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
|
Anxiety an uneasy fearful feeling is the hallmark of many psychological disorders Rate of anxiety disorder is increasing with change in lifestyle where people are subjected to various stress psychiatric/mental diseases are more troublesome to a person in comparison with physical disorder Usage of modern system of medicines like anti-anxiety medications anti depressants and beta blockers which leads to suppression and or palliation so the anxiety may reoccur often and become chronic The onset SAD is generally late childhood and adolescence Although it may develop at any age it rarely occurs for the first time after the age of group of 25 In India due to lack of awareness and perceived stigma majority of people suffering with social anxiety disorder goes undiagnosed and untreated there is a need to address it as it plays a major role in overall well being of the person According to research the prevalence of social anxiety disorder is more between the age group of 18 to 29 so I would like to study in this particular age group highlighting the importance of treating social anxiety disorder using SAD D scale The homoeopathic remedies are effective in management of social anxiety disorder in age group of18 to 29 years Social phobia involves a fear of embarrassment or humiliation in situations in which one must interact with other people eg fear of speaking in public using public lavatories or eating in public Some people with social phobia may have exhibited behavioral inhibition during childhood Perhaps associated with this trait, which is thought to be biologically based are the psychologically based data indicating that the parents of people with social phobia were as a group less caring more rejecting or more overprotective of their children than compared to other parents
Follow up of each subject will be scheduled once in 15 days for the first 2 months and later once in every month till the end of the research and depending upon the need |