| CTRI Number |
CTRI/2025/08/092594 [Registered on: 07/08/2025] Trial Registered Prospectively |
| Last Modified On: |
06/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
The role of individualized homoeopathic medicine in managing stress in students preparing for medical entrance exam
|
|
Scientific Title of Study
|
A RANDOMISED PLACEBO CONTROLLED STUDY TO ASSESS THE ROLE OF INDIVIDUALIZED HOMOEOPATHIC
MEDICINES IN MANAGING STRESS IN STUDENTS PREPARING FOR MEDICAL ENTRANCE EXAM
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vanshika Saini |
| Designation |
MD, PGR (post graduate resident) |
| Affiliation |
SWASTHYA KALYAN HOMOEOPATHIC MEDICAL COLLEGE AND RESEARCH CENTRE |
| Address |
10 A SITAPURA INSTITUTIONAL AREA SITAPURA TONK ROAD JAIPUR
10 A SITAPURA INSTITUTIONAL AREA SITAPURA TONK ROAD JAIPUR
Jaipur
RAJASTHAN
302001
India |
| Phone |
07597366302 |
| Fax |
|
| Email |
vanshika.saini34@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr chandrabhan sharma |
| Designation |
Associate professor, Department of Psychiatry |
| Affiliation |
SWASTHYA KALYAN HOMOEOPATHIC MEDICAL COLLEGE AND RESEARCH CENTRE |
| Address |
SWASTHYA KALYAN HOMOEOPATHIC MEDICAL COLLEGE AND RESEARCH CENTRE 10 A SITAPURA INSTITUTIONAL AREA SITAPURA TONK ROAD JAIPUR
10 A SITAPURA INSTITUTIONAL AREA SITAPURA TONK ROAD JAIPUR
Jodhpur
RAJASTHAN
302021
India |
| Phone |
07597366302 |
| Fax |
|
| Email |
CBHANSOHAM2012@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr chandrabhan sharma |
| Designation |
Associate professor, Department of Psychiatry |
| Affiliation |
SWASTHYA KALYAN HOMOEOPATHIC MEDICAL COLLEGE AND RESEARCH CENTRE |
| Address |
SWASTHYA KALYAN HOMOEOPATHIC MEDICAL COLLEGE AND RESEARCH CENTRE 10 A SITAPURA INSTITUTIONAL AREA SITAPURA TONK ROAD JAIPUR
10 A SITAPURA INSTITUTIONAL AREA SITAPURA TONK ROAD JAIPUR
Jaipur
RAJASTHAN
302021
India |
| Phone |
07597366302 |
| Fax |
|
| Email |
CBHANSOHAM2012@gmail.com |
|
|
Source of Monetary or Material Support
|
| SWASTHYA KALYAN HOMOEOPATHIC MEDICAL COLLEGE AND RESEARCH CENTRE 10 A SITAPURA INSTITUTIONAL AREA SITAPURA TONK ROAD JAIPUR RAJASTHAN 302022
|
|
|
Primary Sponsor
|
| Name |
SWASTHYA KALYAN HOMOEOPATHIC MEDICAL COLLEGE AND RESEARCH CENTRE |
| Address |
SWASTHYA KALYAN HOMOEOPATHIC MEDICAL COLLEGE AND RESEARCH CENTRE 10 A SITAPURA INSTITUTIONAL AREA SITAPURA TONK ROAD JAIPUR RAJASTHAN 302022 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Vanshika Saini |
SWASTHYA KALYAN HOMOEOPATHIC MEDICAL COLLEGE AND RESEARCH CENTRE |
OPD MEDICINE 2 ROOM NUMBER 30 DEPARTMENT PSYCHIATRY SWASTHYA KALYAN HOMOEOPATHIC MEDICAL COLLEGE AND RESEARCH CENTRE 10 A SITAPURA INSTITUTIONAL AREA SITAPURA TONK ROAD JAIPUR
Jaipur
RAJASTHAN |
07597366302
vanshika.saini34@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SWASTHYA KALYAN HOMOEOPATHIC MEDICAL COLLEGE INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F438||Other reactions to severe stress, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathic medicines |
4 pills HS
pills number 40
route of drug administration sublongual |
| Comparator Agent |
Placebo |
4 pills HS
pill number 40
route of administration sublingual |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Students aged between 16 to 25 years.
Actively preparing for medical entrance examinations NEET.
Reporting moderate 14-26 to high 27-40 stress levels as determined by a validated stress
assessment tool PSS-10. |
|
| ExclusionCriteria |
| Details |
Students currently receiving allopathic psychiatric treatment or psychotropic medication.
Diagnosed with major psychiatric illnesses such as bipolar disorder, schizophrenia, or
substance use disorder.
Suffering from chronic physical conditions (e.g., epilepsy, diabetes, cardiovascular
disorders) that may affect the study outcome. Pregnant and lactating females. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To demonstrate that individualized homoeopathic medicine significantly
reduces stress levels in students preparing for medical entrance examinations when compared to
placebo. |
12 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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)
|
29/08/2025 |
| 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="1"
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 - NO
|
|
Brief Summary
|
The present study is designed as a randomized controlled, single-blind, parallel arm clinical trial to evaluate the effectiveness of individualized homoeopathic medicines in managing stress among students preparing for medical entrance examinations. A total of 84 participants will be selected using a Computerised Simple Random sampling method and allocated equally into two groups of 42 each.Experimental group will receive individualized constitutional homoeopathic remedie and Control group will receive a placebo. |