| CTRI Number |
CTRI/2025/04/085956 [Registered on: 29/04/2025] Trial Registered Prospectively |
| Last Modified On: |
07/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Utility of Homoeopathic medicine in primary dysmenorrhoe
|
|
Scientific Title of Study
|
Utility Of Homoeopathic Medical Repertory By Dr Robin Murphy In Management Of Primary Dysmenorrhoea
|
| 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 Soham Bhatt |
| Designation |
Pg scholar |
| Affiliation |
Rajkot Homoeopathic Medical College |
| Address |
Department of Case Taking and Repertory,Rajkot Homeopathic Medical College,Behind jainath complex,makkam chowk,Rajkot Department of Case Taking and Repertory, Rajkot Homoeopathic Medical College, Behind jainath complex , makkam chowk , Rajkot Rajkot GUJARAT 360002 India |
| Phone |
9824816698 |
| Fax |
|
| Email |
sohambhatt1606@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Madhuri Udmale |
| Designation |
Assistant Professor |
| Affiliation |
Rajkot Homeopathic Medical College |
| Address |
Department of Case Taking and Repertory Rajkot Homeopathic Medical College,Behind jainath complex,makkam chowk,Rajkot
Rajkot GUJARAT 360002 India |
| Phone |
9423465288 |
| Fax |
|
| Email |
madhuri.udmale31606@paruluniversity.ac.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Madhuri Udmale |
| Designation |
Assistant Professor |
| Affiliation |
Rajkot Homeopathic Medical College |
| Address |
Department of Case Taking and Repertory Rajkot Homeopathic Medical College,Behind jainath complex,makkam chowk,Rajkot
Rajkot GUJARAT 360002 India |
| Phone |
9423465288 |
| Fax |
|
| Email |
madhuri.udmale31606@paruluniversity.ac.in |
|
|
Source of Monetary or Material Support
|
| Rajkot Homeopathic Medical College, Rajkot, Gujarat, India,360002 |
|
|
Primary Sponsor
|
| Name |
Rajkot Homeopathic Medical College |
| Address |
Rajkot Homeopathic Medical College,behind jainath complex,makkam chowk, Rajkot |
| 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 Soham Bhatt |
Rajkot Homeopathic Medical College |
Department of Case Taking and Repertory, Rajkot Homeopathic Medical College,behind jainath complex,makkam chowk, Rajkot,Gujarat Rajkot GUJARAT |
9824816698
sohambhatt1606@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Comittee For Human Research Rajkot Homoeopathic Medical College (RHMC) Parul University, Gujarat |
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 |
Homoeopathic medicines |
Homoeopathic medicine will be prescribed mode of administration: oral (sublingual) selection of potency: 6,30,200,1M potency selection of potency and dosage: potency and repetition will be according to susceptibility of patient and principle of organon of medicine and will be done every month after follow up till 6 months |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
19.00 Year(s) |
| Gender |
Female |
| Details |
nulliparous females.
females having no pelvic pathology.
age group since menarche to 19 years of age.
females having regular menstrual cycle |
|
| ExclusionCriteria |
| Details |
females having any pelvic pathology.
case of secondary dysmenorrhoea are to be excluded.
females above age of 19 years are to be excluded.
patients on OC pills or any other mode of treatment |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To ascertain the role of Homoeopathic Medical Repertory by Dr. Robin Murphy in cases of primary dysmenorrhoea.To ascertain the rubrics which are accessible in the case of primary dysmenorrhoea from Homoeopathic Medical Repertory by Dr. Robin Murphy |
There will be some improvement after prescribing homoeopathic medicine which will be assessed at 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Significant outcome: patient with sense of well being with decrease in score between 1-4.Moderate improvement:patient wity sense of well being & decrease in score between 5-7.
No improvement or status quo: there is no considerable change observed in complaints & no decrease in score even after administration of
medicine.
|
There will be some improvement
after prescribing homoeopathic
medicine after 9 months |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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)
|
10/05/2025 |
| 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="0" Days="9" |
|
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
Modification(s)
|
Normally life stage of typical women is divided into infancy, puberty(adolescence), sexual maturation (reproductive age), climacteric period and post climacteric period (elderly).Puberty being developmental period where hormonal, psychological and physical change occurs simultaneously; menarche being the first menstrual period in females that typically occurs between the ages of 10 -16 years with the average age of onset being 12.4 years.Primary dysmenorrhoea is a common complaint among both young and adult females. The onset of primary dysmenorrhoea predominantly occurs during adolescence, usually within 6 to 24 months after menarche. Primary dysmenorrhoea is defined as pain during menstrual cycle in the absence of any other recognisable cause and it is the most common cause of pelvic pain. The impact of primary dysmenorrhoea ranges from 45% - 95% in females of reproductive age group worldwide where 2%-29% females experience severe pain and a greater prevalence about 70%- 90% is generally reported in younger females.Primary dysmenorrhoea negatively affects females’ quality of life and interferes with daily activities. The pathophysiology of primary dysmenorrhoea is likely a result of the cyclooxygenase pathway that increase prostanoids particularly prostaglandins. The high level of prostaglandins causes uterine contraction that restrict the blood flow and leads to the production of anaerobic metabolites that stimulates pain receptors. Females with the typical history of primary dysmenorrhoea starts with the empirical treatment that includes pain relieving medications, anti-inflammatory medications, rarely oral combined contraceptive pills, heat application (hot water bag), and regular exercise.Primary dysmenorrhoea is not only a physical issue but it’s a psychosocial issue affecting the life of females. Psychosocial issue in the sense of various orthodox thoughts, beliefs that are followed in the society, their impact on an immature teenager girl makes her more non communicable, antisocial, emotionally vulnerable, and also affects her intellectual skills and abilities.The empirical method of taking medications like pain killers, antiinflammatory or oral combined contraceptive pills have pros and cons, if we focus on the cons they have a bad effect on the individual in the form of constipation, stomach discomfort, bleeding problem, abnormal weight gain, hepatotoxicity, body swelling etc… According to WHO the definition of health is “a complete state of physical, mental and social well-being and not merely the absence of disease.” Homoeopathy is a scientific and effective system of holistic healing having a concept of like cures like. Based on the principle that substance that cause symptoms in the healthy individual can alleviate similar symptoms in a sick individual. Conventional system works only on the particular part of the body and not on whole body but homoeopathy considers the whole person that is mind, body, emotion and spirit. |