| 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
|
|
|
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
|
|
|
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. |