| CTRI Number |
CTRI/2023/09/057469 [Registered on: 12/09/2023] Trial Registered Prospectively |
| Last Modified On: |
01/09/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy
Behavioral |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A PROSPECTIVE STUDY ON DYSMENORRHEA TO EVALUATE THE CORRELATION WITH STRESS FACTORS, USING PERCEIVED STRESS SCALE AND TO ASSESS THE EFFICACY OF HOMOEOPATHIC TREATMENT OF DYSMENORRHEA USING WaLIDD SCORING |
|
Scientific Title of Study
|
A Study to assess the effectiveness of Homoeopathy in treating painful menstruation (primary dysmenorrhea)and to assess the correlation of painful menses and stress factors |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Meenu Maria Mathew |
| Designation |
Assistant Professor |
| Affiliation |
Vinayaka Missions Homoeopathic Medical College and Hospital, Salem, Tamil Nadu |
| Address |
Assistant Professor
Department of Obstetrics and Gynaecology
Vinayaka Missions Homoeopathic Medical College and Hospital, Salem, Tamil Nadu
Salem
TAMIL NADU
636308
India |
| Phone |
8904512857 |
| Fax |
|
| Email |
meenumaria.mathew27@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Meenu Maria Mathew |
| Designation |
Assistant Professor |
| Affiliation |
Vinayaka Missions Homoeopathic Medical College and Hospital, Salem, Tamil Nadu |
| Address |
Assistant Professor
Department of Obstetrics and Gynaecology
Vinayaka Missions Homoeopathic Medical College and Hospital, Salem, Tamil Nadu
Salem
TAMIL NADU
636308
India |
| Phone |
8904512857 |
| Fax |
|
| Email |
meenumaria.mathew27@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Meenu Maria Mathew |
| Designation |
Assistant Professor |
| Affiliation |
Vinayaka Missions Homoeopathic Medical College and Hospital, Salem, Tamil Nadu |
| Address |
Assistant Professor
Department of Obstetrics and Gynaecology
Vinayaka Missions Homoeopathic Medical College and Hospital, Salem, Tamil Nadu
Salem
TAMIL NADU
636308
India |
| Phone |
8904512857 |
| Fax |
|
| Email |
meenumaria.mathew27@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vinayaka Missions Homoeopathic Medical College and Hospital NH 47 Sankari Main Road Seeragapadi P O Salem, Tamil Nadu 636308 India |
|
|
Primary Sponsor
|
| Name |
Vinayaka Missions Homoeopathic Medical College and Hospital, Salem |
| Address |
NH 47 Sankari Main Road Seeragapadi P O Salem, Tamil Nadu 636308, India |
| 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 Meenu Maria Mathew |
Vinayaka missions homoeopathic medical college and hospital salem |
OBG Unit
Out-patient department/ In-patient department
Vinayaka Missions Homoeopathic medical college and Hospital, Salem
Salem
TAMIL NADU |
7760772857
meenumaria.mathew27@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INTITUTIONAL ETHICAL COMMITTEE VINAYAKA MISSIONS KIRUPANANDA VARIYAR MEDICAL COLLEGE AND HOSPITAL SALEM |
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 Medicine with Stress Management |
Medicines will be taken based on totality of symptoms. In case of acute emergencies acute totality will be considered for medication
Potency selection depends on the case |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
17.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Female |
| Details |
Females of reproductive age group
females suffering from dysmenorrhea and stress
|
|
| ExclusionCriteria |
| Details |
Dysmenorrhea with known pelvic pathology
Females already under medications for primary dysmenorrhea |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Effective Treatment of Primary dysmenorrhea
WaLLID Score will be reduced
Stress factors , if any, will be identified and treated
perceived stress scale scoring will be reduced after treatment |
Effective Treatment of Primary dysmenorrhea |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Effectiveness of homoeopathic medicines in treating dysmenorrhea
effective treatment for stress |
stress management
specific management with homoeopathic medicines
Perceived stress scale scoring will be reduced |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
20/09/2023 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Dysmenorrhea
refers to painful menstruation of sufficient magnitude so as to incapacitate
the day to day activities. It is one of the most common gynecological condition
that affect the quality of life of many women in their reproductive years.
Dysmenorrhea viewed as a multifactorial condition which extends from physical
level to psychological level. Dysmenorrhea has been classified in to primary
and secondary based on these etiological factors. Primary Dysmenorrhea is
characterized by menstrual cramps which are not due to pelvic pathology. So
that it can be treated much better than Secondary Dysmenorrhea. This study is
to evaluate the correlation of Primary dysmenorrhea with stress factors, using ‘perceived
stress scale’ and to assess the homoeopathic treatment of primary dysmenorrhea
using ‘WaLIDD scoring.’ |