| CTRI Number |
CTRI/2025/09/094272 [Registered on: 04/09/2025] Trial Registered Prospectively |
| Last Modified On: |
04/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study on management of Generalized Anxiety Disorder in adult age group using Homoeopathic medicines |
|
Scientific Title of Study
|
Efficacy of individualized homoeopathic medicines in the management of Generalized Anxiety Disorder in age group of 18 to 40 years |
| 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 Shibani Dutta |
| Designation |
PG STUDENT |
| Affiliation |
Dr DY PATIL HOMOEOPATHIC MEDICAL COLLEGE AND RESEARCH CENTRE SANT TUKARAM NAGAR PIMPRI PUNE 411018 |
| Address |
Dr DY PATIL HOMOEOPATHIC MEDICAL COLLEGE AND RESEARCH CENTRE SANT TUKARAM NAGAR PIMPRI PUNE 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
8638545065 |
| Fax |
|
| Email |
shibanidutta600@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shibani Dutta |
| Designation |
PG STUDENT |
| Affiliation |
Dr DY PATIL HOMOEOPATHIC MEDICAL COLLEGE AND RESEARCH CENTRE SANT TUKARAM NAGAR PIMPRI PUNE 411018 |
| Address |
Dr DY PATIL HOMOEOPATHIC MEDICAL COLLEGE AND RESEARCH CENTRE SANT TUKARAM NAGAR PIMPRI PUNE 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
8638545065 |
| Fax |
|
| Email |
shibanidutta600@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ayush Kumar Gupta |
| Designation |
Professor |
| Affiliation |
Dr DY PATIL HOMOEOPATHIC MEDICAL COLLEGE AND RESEARCH CENTRE SANT TUKARAM NAGAR PIMPRI PUNE 411018 |
| Address |
Dr DY PATIL HOMOEOPATHIC MEDICAL COLLEGE AND RESEARCH CENTRE SANT TUKARAM NAGAR PIMPRI PUNE 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
8793358167 |
| Fax |
|
| Email |
ayush.kumar@dpu.edu.in |
|
|
Source of Monetary or Material Support
|
| OPD IPD COMPLEX DEPARTMENT OF HOMOEOPATHIC MATERIA MEDICA GROUND FLOOR DR DY PATIL HOMOEOPATHIC MEDICAL COLLEGE AND RESEARCH CENTRE PIMPRI PUNE |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 Shibani Dutta |
Dr DY Patil Homoeopathic medical college and research centre |
HOMOEOPATHIC OPD IPD COMPLEX 1ST FLOOR DEPARTMENT OF HOMOEOPATHIC MATERIA MEDICA DR DY PATIL HOMOEOPATHIC MEDICAL COLLEGE AND RESEARCH CENTRE PIMPRI PUNE
Pune
MAHARASHTRA |
8638545065
shibanidutta600@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr DY Patil Homoeopathic Medical College and Research Centre Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F411||Generalized anxiety disorder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized Homoeopathic Medicine |
Individualized Homoeopathic Medicine and potency as per the case |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Pre-diagnosed patients with Generalized Anxiety Disorder will be included in this study Cases which fulfilled GRADE 0 to GRADE 3 symptoms under HAMILTON ANXIETY RATING SCALE will be included in this study |
|
| ExclusionCriteria |
| Details |
Participants belonging to GRADE 4 under HAMILTON ANXIETY RATING SCALE will not be included in this study Participants must not have a diagnosis of any other psychiatric illness in the present ( likely Panic disorder Agoraphobia Specific phobia Social Phobia Obsessive Compulsive Disorder Acute stress disorder Post traumatic stress disorder Female participants must not be pregnant Female participants must not be breastfeeding Individuals below 18 years and above 40 years will not be included in this study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the efficacy of the Homoeopathic Constitutional medicines in the management of Generalized Anxiety disorder |
To assess the efficacy of the Homoeopathic Constitutional medicines in the management of Generalized Anxiety disorder
1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the role of miasm in the management of Generalized Anxiety Disorder |
To assess the role of miasm in the management of Generalized Anxiety Disorder
1 to 2 months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
30/10/2025 |
| 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="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
|
This is a single arm experimental study to assess the effectiveness of Individualized Homoeopathic medicines in the management of Generalized Anxiety Disorder in age group of 18 to 40 years using the Hamilton Anxiety Rating Scale and patients belonging to Grade 0 to Grade 3 will be included in this study and a total of 50 patients will be included in this study |