| CTRI Number |
CTRI/2026/03/105107 [Registered on: 02/03/2026] Trial Registered Prospectively |
| Last Modified On: |
01/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study to Compare the Effect of Homeopathic Treatment Alone and Homeopathy Combined with Yoga Therapy in Women Suffering from Menstrual Problems. |
|
Scientific Title of Study
|
Comparative Study of Homoeopathy Alone and Combined with Yoga Therapy in the Management of Menstrual Disorders in Reproductive Age Women – An Experimental Comparative Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| pg@gurumishrihmc.edu.in |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prajakta Pandharinath Pise |
| Designation |
Pg Scholar |
| Affiliation |
Guru Mishri Homeopathic Medical College and hospital shelgaon, Jalna |
| Address |
OPD NO .9 MEDICINE OPD, GURU MISHRI HOMEOPATHIC MEDICAL COLLEGE AND HOSPITAL ,SHELGAON BADNAPUR ,JALNA .
MAHARASHTRA ,INDIA PINCODE- 431202
Pune
MAHARASHTRA
431202
India |
| Phone |
9067374239 |
| Fax |
02482262025 |
| Email |
prajupise24@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR .TOOFAN TAPAN CHAKRAVORTY |
| Designation |
PG GUIDE AND PROFESSOR |
| Affiliation |
Guru Mishri Homeopathic Medical College and hospital shelgaon, Jalna |
| Address |
DEPARTEMENT OF PRACTICE OF MEDICINE,GURU MISHRI HOMEOPATHIC MEDICAL COLLEGE AND HOSPITAL,SHELGAON BADNAPUR ,JALNA MAHARASHTRA,INDIA PINCODE- 431202
Jalna
MAHARASHTRA
431202
India |
| Phone |
8308808292 |
| Fax |
02482262025 |
| Email |
drttc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR .TOOFAN TAPAN CHAKRAVORTY |
| Designation |
PG GUIDE AND PROFESSOR |
| Affiliation |
Guru Mishri Homeopathic Medical College and hospital shelgaon, Jalna |
| Address |
DEPARTEMENT OF PRACTICE OF MEDICINE,GURU MISHRI HOMEOPATHIC MEDICAL COLLEGE AND HOSPITAL,SHELGAON BADNAPUR ,JALNA MAHARASHTRA,INDIA PINCODE- 431202
Jalna
MAHARASHTRA
431202
India |
| Phone |
8308808292 |
| Fax |
02482262025 |
| Email |
drttc@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD NO.9 MEDICINE OPD GURU MISHRI HOMEOPATHIC MEDICAL COLLEGE AND HOSPITAL ,SHELGAON JALNA,MAHARASHTRA ,INDIA
PINCODE-431202 |
|
|
Primary Sponsor
|
| Name |
Dr Prajakta Pandharinath Pise |
| Address |
GURU MISHRI HOMEOPATHIC MEDICAL COLLEGE AND HOSPITAL , SHELGAON JALNA , MAHARASHTRA PINCODE- 431202 |
| 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 |
| DrYogesh Desarda |
Guru Mishri Homeopathic Medical College |
OPD NO.9 MEDICINE OPD,GURU MISHRI HOMEOPATHIC MEDICAL COLLEGE AND HOSPITAL SHEALGAON , JALNA ,MAHARAHSTRA ,INDIA- PINCODE 431202
Jalna
MAHARASHTRA |
8856828282
02482262025
pg@gurumishrihmc.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GMHMCIEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N948||Other specified conditions associated with female genital organs and menstrual cycle, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized Homeopathic Medicine |
Individualized Homeopathic similimum selected on totality of symptoms
Potency-30C / 200C (as per case requirement)
Dose-4 globules per dose
Frequency: Once daily or as per individual case need
Route of Administration: Oral |
| Comparator Agent |
Individualized Homeopathic Treatment Combined With Structured Yoga Therapy |
Participants in this group will receive individualized homeopathic treatment based on detailed case taking and totality of symptoms according to classical homeopathic principles. Medicines will be prescribed in appropriate potency and repetition as per individual requirement. In addition, structured yoga therapy including selected asanas and pranayama |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
female age 15-45 years
Diagnosed with menstrual disorder
Willing to participate and follow up regularly |
|
| ExclusionCriteria |
| Details |
preganant women
recent surgery
female diagnosed with pelvic pathologies endometriosis uterine fibroid
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary outcome-
1.Symptom Reduction
Frequency of symptoms: how often dysmenorrhea,
PMS/menorrhagia occurs.
Intensity of symptoms: Measured using scales like Visual Analog Scale (VAS) for pain.
2. Quality of Life (QoL) Measures Physical well-being: Fatigue,sleep disturbances, physical discomfort.
Emotional and psychological health: Anxiety, mood swings,
irritability (often assessed using validated scales like VAS SCALE. |
Monthly follow-up or as per the need of the cases. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the symptom reduction, frequency of symptoms, & quality of life measures. |
Monthly follow-up or as per the need of the cases. |
|
|
Target Sample Size
|
Total Sample Size="1000"
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
|
N/A |
|
Date of First Enrollment (India)
|
18/03/2026 |
| 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="2"
Months="6"
Days="2" |
|
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [PRAJUPISE24@gmail.com].
- For how long will this data be available start date provided 16-07-2025 and end date provided 16-07-2027?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Menstrual disorders are common among women in the reproductive age group and are often associated with symptoms such as dysmenorrhea, irregular cycles, menorrhagia, premenstrual syndrome (PMS), mood disturbances, fatigue, and reduced quality of life. These conditions significantly affect physical health, psychological well-being, and daily functioning. Despite their high prevalence, menstrual health problems are frequently neglected. Homeopathy is widely used in gynecological disorders and may help in symptom relief; however, available evidence shows mixed results and lacks large-scale comparative studies. Similarly, yoga practices including asanas, pranayama, and Yoga Nidra have demonstrated beneficial effects in reducing stress, regulating menstrual cycles, and improving overall well-being. Most previous studies focus on short-term symptomatic improvement, and limited research has compared combined therapy with single-modality treatment. Therefore, this experimental comparative study aims to evaluate the effectiveness of homeopathy alone versus homeopathy combined with yoga therapy in the management of menstrual disorders in reproductive age women. The study intends to generate scientific evidence regarding whether integrative therapy provides superior clinical outcomes and improves overall quality of life. |