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CTRI Number  CTRI/2024/06/069165 [Registered on: 19/06/2024] Trial Registered Prospectively
Last Modified On: 18/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Other 
Public Title of Study   Homoeopathic Treatment in Social Anxiety Disorder 
Scientific Title of Study   To evaluate the effect of constitutional homoeopathic treatment in Social Anxiety Disorder–A Prospective Open Label Interventional Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
U1111-1309-0253  UTN 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shreyasi Sengupta 
Designation  Post Graduate Trainee 
Affiliation  The Calcutta Homoeopathic Medical College and Hospital 
Address  OPD NO.21,Department of Practice of Medicine ,The Calcutta Homoeopathic Medical College and Hospital 265-266, Acharya Prafulla Chandra Road

Kolkata
WEST BENGAL
700009
India 
Phone  08250990335  
Fax    
Email  shreyasisengupta29@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Rupali Bhaduri 
Designation  Reader, Department. of Practice of Medicine 
Affiliation  The Calcutta Homoeopathic Medical College and Hospital 
Address  Department of Practice of Medicine,The Calcutta Homoeopathic Medical College and Hospital 265-266, Acharya Prafulla Chandra Road

Kolkata
WEST BENGAL
700009
India 
Phone  9571806989  
Fax    
Email  drrupalibhaduri@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Rupali Bhaduri 
Designation  Reader, Department. of Practice of Medicine 
Affiliation  The Calcutta Homoeopathic Medical College and Hospital 
Address  Department of Practice of Medicine,The Calcutta Homoeopathic Medical College and Hospital 265-266, Acharya Prafulla Chandra Road

Kolkata
WEST BENGAL
700009
India 
Phone  9571806989  
Fax    
Email  drrupalibhaduri@gmail.com  
 
Source of Monetary or Material Support  
The Calcutta Homoeopathic Medical College & Hospital, Govt. of West Bengal 265,266, Acharya Prafulla Chandra Road, Kolkata 700009 
 
Primary Sponsor  
Name  The Calcutta Homoeopathic Medical College & Hospital 
Address  265,266, Acharya Prafulla Chandra Road, Kolkata 700009 
Type of Sponsor  Government 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 Shreyasi Sengupta  The Calcutta Homoeopathic Medical College & Hospital  Medicine OPD NO.21 265,266, Acharya Prafulla Chandra Road Kolkata 700009,West Bengal
Kolkata
WEST BENGAL 
08250990335

shreyasisengupta29@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of The Calcutta Homoeopathic Medical College 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 medicine along with psychological counselling by psychologist.  1 Participants will be given individualized homoeopathic medicine along with psychological counselling by psychologist. 2 Selection, potency, dose and repetition of medicine will be as per homoeopathic principles. 3 Medicine will be produced from a GMP certified pharmaceutical company. 4 Follow up action: After first prescription, participants will be evaluated by Severity measure of social anxiety disorder score. It will be done at baseline, and at the end of every 2 months upto 6months.Likewise,SF36 will also be done at baseline and at the end of every 2 months upto 6months.Every patient will be followed up at 15 days of interval for 6months.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  • Inclusion criteria:
1 Aged between 18-65years
2 Patients fulfilling the diagnostic criteria for Social Anxiety Disorder as per DSM 5.
3 Patients willing to join the study and sign the informed consent form.
4 Patients with either gender,including transgender
5 Literate patients able to read and write English ,Bengali or Hindi.
6 No history of medications since last 6 months period, prior to entry into the study
 
 
ExclusionCriteria 
Details  1 Patients with other psychiatric disorder.
2 Pregnant women, Lactating mothers and children.
3 Patients with metabolic disorders and other systemic disorders
4 Current psychoactive substance dependence or substance abuse.
5 Previous psychological therapy in the last 1 year.
6 Head injury or other neurological disorder.
7 H/o suicidal or self harming tendency.
8 Patients who are too sick for consultation.
9 Simultaneous participation of any other clinical trials.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Social Anxiety Disorder Severity Scale  At the end of every 2 months upto 6months,with follow up every 15 days 
 
Secondary Outcome  
Outcome  TimePoints 
The 36-Item Short Form Health Survey questionnaire (SF-36)  At the end of every 2 months upto 6months,with follow up every 15 days 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   30/06/2024 
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="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  

Social anxiety disorder; ICD11:6B04;(also referred to as social phobia) involves the fear of social situations, including situations that involve scrutiny or contact with strangers. They are fearful of embarrassing themselves in social situations (i.e., social gatherings, oral presentations, meeting new people).It is the third most common psychiatric condition after major depression and alcohol dependence. Educational achievement can be undermined, with a heightened risk of leaving school early and resulting in poor academic performance and qualifications.Left untreated, social anxiety disorder is recognized as a debilitating and highly prevalent disorder that may result in lower educational attainment, worse occupational performance, hampered social interaction, lower-quality relationships, and decreased quality of life. SAD is associated with suicidal ideation, low self-esteem, lower socioeconomic status, unemployment, financial issues, and being unmarried. There is a lot of scope in the practice of homeopathy in mental diseases. Due to unavailability of studies in homoeopathy in this field, studies need to be conducted. Prospective Open Label Interventional Study will be conducted on Outpatients of Calcutta Homoeopathic Medical College, Kolkata, for 18months.Due to lack of literature on this subject and time constraints,60 was taken as sample size. Assessment done by two scales Social Anxiety Disorder Severity Scale (SAD-D) and 36-Item Short Form Health Survey questionnaire (SF-36). Results will be published in scientific journals.


 
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