| CTRI Number |
CTRI/2025/09/094891 [Registered on: 16/09/2025] Trial Registered Prospectively |
| Last Modified On: |
16/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Role of the lesser known homoeopathic medicine Triticum vulgare in relieving period pain related to supressed emotion in primary dysmenorrhea |
|
Scientific Title of Study
|
Exploring the efficacy of lesser-known homoeopathic medicine Triticum vulgare in Cases of Primary
Dysmenorrhea on the Basis of Emotional Suppression: A Clinical Trial Study |
| 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 Arunima |
| Designation |
PG Scholar |
| Affiliation |
Dr M P K Homoeopathic Medical College Hospital And Research Centre |
| Address |
Department of Homoeopathic Pharmacy Dr M P K Homoeopathic Medical College And Research Centre A Constituent College of Homoeopathy University Saipura Sanganer Jaipur Rajasthan
Jaipur
RAJASTHAN
302029
India |
| Phone |
7014815929 |
| Fax |
|
| Email |
arunima9455@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gajraj Singh Rathore |
| Designation |
Professor |
| Affiliation |
Dr M P K Homoeopathic Medical College Hospital And Research Centre |
| Address |
Department of Homoeopathic Pharmacy Dr M P K Homoeopathic Medical College And Research Centre A Constituent College of Homoeopathy University Saipura Sanganer Jaipur Rajasthan
Jaipur
RAJASTHAN
302029
India |
| Phone |
9414362202 |
| Fax |
|
| Email |
gsrbachwari@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gajraj Singh Rathore |
| Designation |
Professor |
| Affiliation |
Dr M P K Homoeopathic Medical College Hospital And Research Centre |
| Address |
Department of Homoeopathic Pharmacy Dr M P K Homoeopathic Medical College And Research Centre A Constituent College of Homoeopathy University Saipura Sanganer Jaipur Rajasthan
Jaipur
RAJASTHAN
302029
India |
| Phone |
9414362202 |
| Fax |
|
| Email |
gsrbachwari@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Homeopathic Pharmacy Dr Girendra Pal Homoeopathic Hospital And Research Centre Collegiate Hospital of Dr M P K Homoeopathic Medical College And Research Centre A Constituent College Of Homoeopathy University Saipura Sanganer Jaaipur Rajasthan 302029 |
|
|
Primary Sponsor
|
| Name |
Dr M P K Homoeopathic Medical College Hospital And Research Centre |
| Address |
10 11 12 Ward No 36 Saipura Sanganer Jaipur Rajasthan 302029 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Arunima |
Dr Girendra Pal Homoeopathic Hospital And Research Centre |
Department of Homoeopathic Pharmacy OPD Room no 8 Dr M P K Homoeopathic Medical College And Research Centre A Constituent College of Homoeopathy University 10 11 12 Ward no 36 Saipura Sanganer Jaipur Rajasthan
Jaipur
RAJASTHAN |
07014815929
arunima9455@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Homoeopathy University Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N944||Primary dysmenorrhea, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Triticum vulgare |
Homoeopathic Medicine shall be given orally in any potency 6c,30c, 200c, 1M, 10M, 50M, and CM aas per the case and Hahnemannian guidelines of Organon of Medicine in the form of globules of 40 numbers, Dose and Repetition as per need of the case reassessment at the end of 3 month |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1 Females within reproductive age group(14-35)
2 Females having regular menstrual cycle Patient giving consent for the study
3 Any of the 3 following symptoms observed during menstrual period- anatomical pain location, wong baker pain range, number of days of pain, frequency of disabling pain to perform their activities
4 Emotional causation clearly established
|
|
| ExclusionCriteria |
| Details |
1 The cases which require emergency care or rescue treatment
2 Women with surgical menopause
3 Women suffering from any other systemic disorders
4 Patients presenting with advanced pathological cases
5 Patients who are not willing to give informed consent
6 Patient pursuing other treatment and are not willing to leave it
7 Pregnant and lactating females |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| At the end of study expected that Triticum Vulgare will produce variation On the pre and post scores of WaLIDD SCORE |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/10/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Aim To evaluate the efficacy of Triticum vulgare in treating of primary dysmenorrhea on the basis of emotional suppression Objectives To assess the effectiveness of Triticum vulgare in treating of primary dysmenorrhea on the basis of emotional suppression To verify the other symptoms of the drug |