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CTRI Number  CTRI/2025/07/091334 [Registered on: 21/07/2025] Trial Registered Prospectively
Last Modified On: 21/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   Understanding And Management Of Social Anxiety Disorder In Early Adulthood With Homoeopathy 
Scientific Title of Study   To Study Social Anxiety Disorder In Early Adulthood And Its Homoeopathic Management  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  BHUMIKA BHIKHUBHAI KATARIYA 
Designation  MD Scholar Part-2 
Affiliation  C D Pachchigar College Of Homoeopathic Medicine And Hospital  
Address  Department Of Psychiatry Division Of MD 2nd Floor C D Pachchigar College Of Homoeopathic Medicine And Hospital Near Anand Mangal Road Surat Surat GUJARAT 395001 India

Surat
GUJARAT
395001
India 
Phone  7874439259  
Fax    
Email  bhumikakatariya91@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Deepti Yesade 
Designation  Professor Of Homoeopathy Psychiatry 
Affiliation  C D Pachchigar College Of Homoeopathic Medicine And Hospital  
Address  Department Of Psychiatry Division Of MD 2nd Floor C D Pachchigar College Of Homoeopathic Medicine And Hospital Near Anand Mangal Road Surat Surat GUJARAT 395001 India

Surat
GUJARAT
395001
India 
Phone  9403803599  
Fax    
Email  deepti.yesade81@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Deepti Yesade 
Designation  Professor Of Homoeopathy Psychiatry 
Affiliation  C D Pachchigar College Of Homoeopathic Medicine And Hospital  
Address  Department Of Psychiatry Division Of MD 2nd Floor C D Pachchigar College Of Homoeopathic Medicine And Hospital Near Anand Mangal Road Surat Surat GUJARAT 395001 India

Surat
GUJARAT
395001
India 
Phone  9403803599  
Fax    
Email  deepti.yesade81@gmail.com  
 
Source of Monetary or Material Support  
C D Pachchigar College Of Homoeopathic Medicine And Hospital Near Navjivan Circle Udhana Magdalla Road Surat India 395001 
 
Primary Sponsor  
Name  C D Pachchigar College of Homoeopathic Medicine and Hospital  
Address  C D Pachchigar College of Homoeopathic Medicine and Hospital Near Navjivan Circle Udhana Magdalla Road Surat Surat GUJARAT 395001 India 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Bhumika Bhikhubhai Katariya  C D Pachchigar College Of Homoeopathic Medicine And Hospital  Department Of Psychiatry Post Graduation Division 2nd Floor Surat GUJARAT
Surat
GUJARAT 
7874439259

bhumikakatariya91@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee Of C D Pchchigar College Of Homoeopathic Medicine And Hospital   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F401||Social phobias,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Individualized Homoeopathic Medicines   Individualized Homoeopathic Medicine and its dose potency and frequency of repetition will be prescribed on the basis of totality of symptoms and individual susceptibility The medicine will be administered orally within time duration of 9 months 
Comparator Agent  Not Applicable  Not Applicable 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  Patients covering DSM-5 criteria for social anxiety disorder
Patient may need to have experienced symptoms for at least 6 month or more 
 
ExclusionCriteria 
Details  Age below 20 years and above 40 years
Patients who not covering DSM-5 criteria for social anxiety disorder
Patients with known case of severe medical illness
Patients with significant substance abuse or dependence
Patients who currently receiving treatment for social anxiety disorder
Patients already on anxiolytic medication 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To reducing anxiety symptoms, improving social functioning and relationships, increasing confidence in social situations   9 month 
 
Secondary Outcome  
Outcome  TimePoints 
To improve social anxiety with homoeopathic medicine  9 months 
 
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)   01/08/2025 
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="0"
Months="9"
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  
NEED FOR STUDY: 
Data from the National Comorbidity Survey reveals that Social Anxiety Disorder is the third most common psychiatric condition after major depression and alcohol dependence. 

Developmental stage: Early adulthood is a characterized by significant social, emotional and cognitive development. 

Social Functioning: Social Anxiety Disorder can significantly affect individual’s ability to form and maintain relationships, pursue education and career goals and engage in social activities. 

Risk Factors: Research can help identify risk factors and protective factors associated with development and persistence of Social Anxiety Disorder during early adulthood. 

Risk Of Chronicity: If left untreated, Social Anxiety Disorder in early adulthood can persist into later stages of life, leading to chronic impairment and reduced quality of life. 

Stigma Reduction: Research helps us understand the various factors contributing to Social Anxiety Disorder, reducing the stigma around them. 


REVIEW OF LITRATURE: 

INTRODUCTION :
Social Anxiety Disorder (ICD11 CODE - 6B04) is a fear of one or more social situations wherein the patient is concerned about being harshly judged and evaluated for their performance or interpersonal interactions. There is an out of-proportion fear that they will be shamed by the experience. 
Disabling performance anxiety when speaking in front of a crowd is a common example of Social Anxiety Disorder, as is severe anxiety at having to meet and engage with new people. 
According to Indian journal of psychiatry, 2023; the highest prevalence of Social Anxiety Disorder was found among the 18-29 age group is 41%, followed by 30-39 age group is 24%. 
National Mental Health Survey (NMHS); 2016 reports indicate a higher risk of Social Anxiety Disorder among males compared with females. 

DIFFERENTIAL DIAGNOSIS: 
Normative shyness, Agoraphobia, Generalized anxiety disorder, Separation anxiety disorder, Major depressive disorder, etc.

THE PSYCHOLOGY OF SOCIAL ANXIETY DISORDER:
Onset of Social Anxiety Disorder may follow a stressful or humiliating experience (e.g., being bullied, vomiting during a public speech), or it may be insidious, developing slowly. First onset in adulthood is relatively rare and is more likely to occur after a stressful or humiliating event or after life changes that require new social roles (e.g., marrying someone from a different social class, receiving a job promotion). Social anxiety disorder may diminish after an individual with fear of dating marries and may reemerge after divorce. 

HOMOEOPATHIC APPROACH :
Mental diseases of Psychosomatic type (§225): Mental diseases that arise as a result of psychological symptoms, such as fear, anxiety, avoidance behaviour, and negative thoughts related to social situations. Such diseases may be of recent origin and may not have developed fully into corporeal diseases. But if left untreated they may damage the body. According to aphorism 215-216 Hahnemann considers mental disease as onesided diseases of the chronic type affecting the whole psychosomatic entity.

HOMOEOPATHIC MANAGEMENT:
Constitutional homeopathic medicines prescribed as per the patients. Common suitable homeopathic drugs for Social Anxiety Disorder: Aconite, Argentum nit., Gels, Lycopodium, Medo., etc. 

OBJECTIVES OF STUDY: 
1. To reducing anxiety symptoms, improving social functioning and relationships, increasing confidence in social situations. 
2. To improve social anxiety with homoeopathic medicine. 

SOURCE OF DATA :
O.P.D of C.D. PACHCHIGAR Homoeopathic college & hospital. 

DATA ANALYSIS AND METHODS: 
Improved: Subjects showing reduction in anxiety symptoms, improve social functioning, increasing confidence in social situations and decrease in intensity and severity of disease. [Hamilton Anxiety Rating Scale (HAM-A)] 
Not Improved: No clinically favorable improvement after medicinal interventions. 
Left the treatment: Subjects who will not maintain follow-ups till advised to discontinue treatment. 
 
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