| CTRI Number |
CTRI/2025/09/094358 [Registered on: 08/09/2025] Trial Registered Prospectively |
| Last Modified On: |
08/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To treat the patients of Mild Generalized Anxiety Disorder with simple and single homoeopathic medicine in Age group-18 to 26 years in both sexes |
|
Scientific Title of Study
|
Homoeopathic management of mild genralized anxiety disorder in the young adults in the age group of 18 to 26 years a non-randomized non -controlled experimental study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| not applicable |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR NILIMA DINESH BHOJ |
| Designation |
PHD SCHOLAR |
| Affiliation |
YMT HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL |
| Address |
DR D G POL FOUNDATIONS YMT HOMOEOPATHIC MEDICAL AND HOSPITAL DEPARTMENT OF MATERIA MEDICA FOURTH FLOOR SECTOR NO 4 KHARGHAR NEVI MUMBAIE.
Mumbai (Suburban)
MAHARASHTRA
410210
India |
| Phone |
8806539439 |
| Fax |
|
| Email |
nishuneelima@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR VINOD SURYAKANT SAWANT |
| Designation |
ASSOCIATE PROFESSOR MD HOMOEOPATHIC MATERIA MEDICA |
| Affiliation |
YMY HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL |
| Address |
DR D G POL FOUNDATIONS YMT HOMOEOPATHIC MEDICAL COLLGE AND HOSPITAL DEPARMENT OF MATERIA MEDICA FOURTH FLOOR SECTOR NO 4 KHARGHAR NAVI MUMBAIE
Mumbai (Suburban)
MAHARASHTRA
410210
India |
| Phone |
9082553082 |
| Fax |
|
| Email |
drvinodsawant@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR NILIMA DINESH BHOJ |
| Designation |
PHD SCHOLAR |
| Affiliation |
YMT HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL |
| Address |
DR D G POL FOUNDATIONS HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL DEPARMENT OF HOMOEOPATHIC MATERIA MEDICA FOURTH FLOOR SECTOR NO 4 KHARGHAR NEW MUMBAIE
Mumbai (Suburban)
MAHARASHTRA
410210
India |
| Phone |
8806539439 |
| Fax |
|
| Email |
nishuneelima@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Nilima Dinesh Bhoj |
| Address |
Dept of Homoeopathic Materia Medica Dr D G Pol Foundations YMT Homoeoapthic Medical College and Hospital |
| 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 NILIMA DINESH BHOJ |
DR D G Pol foundationsYMT HOMOEOPATHIC MEDICAL COLLEGEAND HOSPITAL KHARGHARNAVI MUMBAI |
DEPARTMENT OF HOMOEOPATHIC MATERIA MEDICA SECTOR DR D G POL FOUNDATIONS HOMOEOPATHIC MEDICAL COLLEGE SECTOR NO 4 KHARGHAR NAVVI MUMBAIE
Mumbai (Suburban)
MAHARASHTRA |
8806539439
nishuneelima@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee of YMT HMC Kharghar Navi Mumbai |
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 |
Individualised Homoeopathic Medicine |
Single Dose of Individualise Homoeopathic Medicine Oraly in the Form of Pills during First Prescription and followup after 2 weeks or as per requirement of Patient for 2 years or till improvement which is earlier |
| Comparator Agent |
Nill |
Nill |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
26.00 Year(s) |
| Gender |
Both |
| Details |
Patient Diagnose with Mild Generalise Anxity Disorder willing to provide writtern inform consent |
|
| ExclusionCriteria |
| Details |
Severe GAD or comoebid psychiatric illness
Current use of anxiolytic or antidepressant drugs
pregnancy or lactation
History of psychosis epilepsy or major medical illness |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| REDUCTION IN GAD SYMPTOMS MEASURED BY USING HAMILTON ANXIETY RATING SCALE |
outcome is assessed at 3 and 6 months of treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement inslip concentration daily functioning assessed by Patient feedback and clinical observation |
Every 6 month scale assessment |
|
|
Target Sample Size
|
Total Sample Size="111"
Sample Size from India="111"
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)
|
25/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
25/09/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [nishuneelima@gmail.com].
- For how long will this data be available start date provided 06-12-2028 and end date provided 01-12-2035?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This study aims to evaluate the effectiveness of indivisulised homoeopathic medicines in the management of genralised anxiety dosorder [ GAD] in young adults aged 18-26years .A total 111 participants meeting DSM-5 creteria for mild GAD will be enrolled . The trial will be a non- randomized,non-controlled,single arm ,open lable experimental desigin .Patient will be assessed during ,and after,homoeopathic intervention.The study wii explore symptoms improvement,quality of life and safety of homoeopathic medicines in this populations.
|