| CTRI Number |
CTRI/2025/07/090522 [Registered on: 09/07/2025] Trial Registered Prospectively |
| Last Modified On: |
08/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effectiveness of Individualized Homoeopathic Medicines In The Management Of Spasmodic Dysmenorrhea |
|
Scientific Title of Study
|
An Analytical Study To Assess The Effectiveness Of Individualized Homoeopathic Medicines In The Management Of Spasmodic Dysmenorrhea By Using WaLIDD Score |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Krupa Mukeshlal Patel |
| Designation |
PG Scholar |
| Affiliation |
C.D. Pachchigar College of Homoeopathic Medicine and Hospital |
| Address |
C D Pachchigar College Of Homoeopathic Medicine And Hospital Department Of Homoeopathic Materia Medica Post Graduation Division 2nd Floor Near Navjivan Circle Udhana Magdalla Road Surat
Surat
GUJARAT
395001
India |
| Phone |
7265984603 |
| Fax |
|
| Email |
krupampatel1110@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mukesh P Khatri |
| Designation |
Associate Professor of Homoeopathic Materia Medica |
| Affiliation |
C.D. Pachchigar College of Homoeopathic Medicine and Hospital |
| Address |
C D Pachchigar College Of Homoeopathic Medicine And Hospital Department Of Homoeopathic Materia Medica Post Graduation Division 2nd Floor Near Navjivan Circle Udhana Magdalla Road Surat
Surat
GUJARAT
395001
India |
| Phone |
9429012500 |
| Fax |
|
| Email |
mukeshkhatri5@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mukesh P Khatri |
| Designation |
Associate Professor of Homoeopathic Materia Medica |
| Affiliation |
C.D. Pachchigar College of Homoeopathic Medicine and Hospital |
| Address |
C D Pachchigar College Of Homoeopathic Medicine And Hospital Department Of Homoeopathic Materia Medica Post Graduation Division 2nd Floor Near Navjivan Circle Udhana Magdalla Road Surat
Surat
GUJARAT
395001
India |
| Phone |
9429012500 |
| Fax |
|
| Email |
mukeshkhatri5@gmail.com |
|
|
Source of Monetary or Material Support
|
| C D Pachchigar College Of Homoeopathic Medicine And Hospital Near Navjivan Circle Udhana Magdalla Road Surat India 395001 |
|
|
Primary Sponsor
|
| Name |
C.D Pachchigar College Of Homoeopathic Medicine And Hospital |
| Address |
C.D Pachchigar College Of Homoeopathic Medicine And Hospital Near Navjivan Circle Udhana Magdalla Road Surat |
| Type of Sponsor |
Private medical college |
|
|
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 Krupa Mukeshlal Patel |
C.D. Pachchigar College Of Homoeopathic Medicine And Hospital |
Department Of Homoeopathic Materia Medica Post Graduation Division 2nd Floor
Surat
GUJARAT |
7265984603
krupampatel1110@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Of C.D.Pachchigar College Of Homoeopathic Medicine And Hospital |
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 |
| Intervention |
Individualized Homoeopathic Medicines |
Individualized Homoeopathic Medicines Will Be Prescribed On The Basis Of Totality Of Symptoms And Individual Susceptibility The Medicine Will Be Administered Orally In The Form Of Medicated Globules 4 To 6 Globules Per Dose The Dose Will Consist Of 3 To 6 Doses Repeated At Intervals From 1 To 6 Hours Depending Upon The Intensity And Acuteness Of The Case The Total Duration Of The Intervention Will Be For The Three Consecutive Menstrual Cycles |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1 Womens Age Group 15 to 40 Year Are Included In My Study
2 Patients Who Are Fulfilling The Diagnostic Criteria Of Spasmodic Dysmenorrhea
|
|
| ExclusionCriteria |
| Details |
1 Cases If Any Gynaecological Emergency With Irreversible Pathological Condition Like Malignancy Pelvic Organ Prolapses Or Any Abnormal Pelvic Pathology Known To Be Associated With Secondary Dysmenorrhea
2 Patient Who Are On Medications From Any Other Pathies Medicines Like NSAIDs Combined Oral Contraceptives Or Progestin only Contraceptives etc
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Evaluate The Effectiveness Of Individualized Homoeopathic Medicines In Reducing The Severity Of Spasmodic Dysmenorrhoea As Measured By Change In WaLIDD Score Over The Study Period |
9 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To Assess The Incidence And Prevalence Rate In Cases Of Spasmodic Dysmenorrhea |
9 Months |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
21/07/2025 |
| 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="0"
Months="9"
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
|
Objective:
To evaluate the effectiveness of individualized homoeopathic remedies in treating spasmodic (primary) dysmenorrhoea using the WaLIDD scoring system, which assesses pain based on workability, location, intensity, and duratio
Background:
Dysmenorrhoea (painful menstruation) is a common condition affecting women’s daily activities and quality of life.
Primary dysmenorrhoea is not associated with pelvic pathology and often occurs in adolescents.
Modern treatments (NSAIDs, antispasmodics) have limitations, prompting the need for effective homoeopathic alternatives.
Methodology:
Study Design: Analytical study
Sample Size: Minimum 30 cases
Sampling Technique: Purposive sampling
Data Source: OPD, IPD, and peripheral postings at C.D. Pachchigar College, Surat
Inclusion: Women aged 15–40 years with primary dysmenorrhoea
Exclusion: Secondary dysmenorrhoea or patients on other medical treatments
Assessment Tool: WaLIDD Score
Follow-up: Minimum 3 menstrual cycles
Homoeopathic Management:
A variety of individualized remedies such as Belladonna, Pulsatilla, Chamomilla, Magnesia Phos., Caulophyllum, Lilium Tigrinum, and others are selected based on patient symptoms and constitutional profile.
Expected Outcome:
To demonstrate a reduction in intensity and frequency of dysmenorrhoeic pain using individualized homoeopathic remedies, validated through the WaLIDD score system
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