| CTRI Number |
CTRI/2024/12/078504 [Registered on: 24/12/2024] Trial Registered Prospectively |
| Last Modified On: |
29/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy
Diagnostic
Preventive
Screening |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Premenstrual syndrome (PMS)affect a significant number of women menifesting as a range of emotional and physical symptoms in the luteal phase of the menstrual cycle |
|
Scientific Title of Study
|
Utility of repertory of homoeopathic materia medica by dr jt kent in cases of premenstrual syndrome |
| 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 vibha A joshi |
| Designation |
BHMS,PG scholar |
| Affiliation |
PARUL INSTITUTE HOMOEOPATHY AND RESEARCH, WAGHODIA,VADODARA |
| Address |
101-OBS/GYNE OPD, Parul institute of homoeopathy and research hospital, waghodia, vadodara,
Vadodara
GUJARAT
391760
India |
| Phone |
7572987918 |
| Fax |
|
| Email |
joshivibha05@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr DishaThakkar Mitra |
| Designation |
BHMS, MD(Hom) |
| Affiliation |
PARUL INSTITUTE HOMOEOPATHY AND RESEARCH, WAGHODIA,VADODARA |
| Address |
101(E) Obstetrics & gynecology OPD Parul institute homoeopathy and research, waghodia, vadodara pin no-391760 india
Vadodara
GUJARAT
391760
India |
| Phone |
9650496890 |
| Fax |
|
| Email |
disha.mitra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr vibha A joshi |
| Designation |
BHMS,PG scholar |
| Affiliation |
PARUL INSTITUTE HOMOEOPATHY AND RESEARCH, WAGHODIA,VADODARA |
| Address |
101-OBS/GYNE OPD, Parul institute of homoeopathy and research hospital, waghodia, vadodara,
Vadodara
GUJARAT
391760
India |
| Phone |
7572987918 |
| Fax |
|
| Email |
joshivibha05@gmail.com |
|
|
Source of Monetary or Material Support
|
| parul institute of homoeopathy and research hospital,parul university, waghodia, vadodara, 391760 (Gujarat),INDIA |
|
Primary Sponsor
Modification(s)
|
| Name |
Dr Vibha Joshi |
| Address |
parul institute of homoeopathy and research hospital waghodia, vadodara pin no- 391760 (Gujarat), India |
| 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 |
| Dr vibha joshi |
Parul institute of homoeopathy and reserch hospital,waghodia,vadodara (gujrat) |
101(E) obstetrics and gynecology opd
Vadodara
GUJARAT |
7572987918
joshivibha05@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional Ethics Committee,PIHR IECHR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N859||Noninflammatory disorder of uterus, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individialised homeopathic medicine |
according to the susceptibility of the patient, i will select the potency,30,200,1M and dosage with follow up every 1 month |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Female |
| Details |
1.Age 18-25year female
2.Symptoms duration – Consistent premenstrual syndrome for at least 3 consecutive menstrual cycle
3.Symptoms severity mild to moderate
4.Menstrual regularity - Regular menstrual cycles (21-35 day) |
|
| ExclusionCriteria |
| Details |
1.Other gynecological condition like endometriosis, fibroid etc.,
2.Hormonal treatment e.g., Birth control pills, Hormone replacement therapy within last 3 months.
3.PMDD (pre menstrual dysphoric disorder)
4.Pregnancy or breast feeding
5.PME (pre menstrual exacerbation symptoms)
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Clinically verify the utility of individualized homeopathic medicine selected from repertory of homeopathic Materia medica by Dr J.T. Kent in cases of premenstrual syndrome. |
12 month with follow up every month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Clinically verify the rubric related to premenstrual syndrome. |
12 month with follow up every month |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/01/2025 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The study explores the utility of Dr. J.T. Kent’s "Repertory of Homeopathic Materia Medica" in addressing PMS. By leveraging Kent’s comprehensive homeopathic framework, the research aims to identify effective remedies that can provide relief from PMS symptoms, highlighting the need for holistic and individualized treatment approaches in managing this common condition. |