| CTRI Number |
CTRI/2026/02/103090 [Registered on: 05/02/2026] Trial Registered Prospectively |
| Last Modified On: |
04/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of Homoeopathic Medicine in the management of painful menses |
|
Scientific Title of Study
|
Utility of Individualized Homoeopathic Medicine In The Management Of Primary Dysmenorrhea -A Prospective Single Arm Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NILL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Premlata Verma |
| Designation |
Postgraduate trainee |
| Affiliation |
State National Homoeopathic Medical College and Hospital Lucknow |
| Address |
Department of Homoeopathic Matera Medica State National Homoeopathic Medical College and Hospital 1-Viraj Khand Gomti Nagar Lucknow. Lucknow UTTAR PRADESH 226010
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
8932807867 |
| Fax |
|
| Email |
premlataverma124@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tripti Gupta |
| Designation |
Lecturer |
| Affiliation |
State National Homoeopathic Medical College And Hospital |
| Address |
Department Of Obs and Gynae State National Homoeopathic Medical College and Hospital 1-Virajkhand Gomti Nagar Lucknow UTTAR PRADESH 226010 India
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
9450651429 |
| Fax |
|
| Email |
dr.triptigupta2013@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Premlata Verma |
| Designation |
Postgraduate trainee |
| Affiliation |
State National Homoeopathic Medical College and Hospital Lucknow |
| Address |
Department of Homoeopathic Matera Medica State National Homoeopathic Medical College and Hospital 1-Viraj Khand Gomti Nagar Lucknow. Lucknow UTTAR PRADESH 226010
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
8932807867 |
| Fax |
|
| Email |
premlataverma124@gmail.com |
|
|
Source of Monetary or Material Support
|
| Out patient department of State National HomoeopathicMedical College and Hospital 1-viraj khand Gomti Nagar Lucknow UTTAR PRADESH 226010 |
|
|
Primary Sponsor
|
| Name |
Dr Premlata Verma |
| Address |
Department Of Homoeopathic Materia Medica State National Homoeopathic Medical College and Hospital 1-viraj khand Gomti Nagar Lucknow Uttar Pradesh 226010 |
| 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 Premlata Verma |
State National Homoeopathic Medical College and Hospital Lucknow |
OPD -6 Department of Homoeopathic Materia Medica State National Homoeopathic Medical College and Hospital 1-Viraj Khand Gomti Nagar Lucknow.Uttar Pradesh
Lucknow
UTTAR PRADESH |
8932807867
premlataverma124@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of State National Homoeopathic Medical College and Hospital Lucknow |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N944||Primary dysmenorrhea, (2) ICD-10 Condition: N944||Primary dysmenorrhea, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized Homoeopathic Medicine |
Patients qualifying to inclusion criteria will be included in the study Proper case taking of all enrolled patients will be done Homoeopathic medicines will be prescribed to all patients after analysis and evaluation of symptoms and proper repertorization Indicated homoeopathic remedy will be administered as decided appropriate to the case or condition in appropriate potency and doses Medicines will be given oral route. Each case will be followed up at regular interval preferably at a period of 15 days or as per requirement Patient will be studied for 6 months after enrolment in study Outcome assessment of the patients will be carried out after 6 months of homoeopathic medication based on WALIDD Score and VAS score |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Female |
| Details |
1.Females aged 12 to 25 years diagnosed with Primary dysmenorrhea clinically.
2.Complaint of Primary dysmenorrhea for at least 3 menstrual cycles |
|
| ExclusionCriteria |
| Details |
1.Females less than 12 years and greater than 25 years will not be included in the study
2.Females having any obvious ovarian or uterine pathologies will be excluded
3.Females with any severe systemic diseases will be excluded
4.Females on OCPs and IUDs inserted will not be taken for the trial. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of individualized homoeopathic medicine using WALIDD score and VAS score before and after treatment . |
To evaluate the effect of individualized homoeopathic medicine using WALIDD score and VAS score before and after treatment . |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of individualized homoeopathic medicine using VAS score and WALIDD score before and after treatment. |
3 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)
|
15/02/2026 |
| 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="6"
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
|
Dysmenorrhea is the medical term used for painful menses. Menstrual pain may begin just before the menses or at the starting of menses and last for as long as 72 hours.it is confirmed to ovulatory cycles only ,hence ,may begin only a few months after menarche .Primary dysmenorrhea where there is no identifiable pelvic pathology present. Primay dysmenorrhea is often a leading cause of absenteeism from schools and colleges ,poor quality of life in young girls and women and decreased productivity at work.
At the end of study ,it is expected that the individualized homoeopathic medicine after proper repertorization will cure the patients who is suffering from primary dysmenorrhea .it is expected that patient improves symptomatology which is evident through the valid scales(WaLIDD and VAS score ). |