| CTRI Number |
CTRI/2024/02/063095 [Registered on: 23/02/2024] Trial Registered Prospectively |
| Last Modified On: |
03/10/2025 |
| 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 premenstrual syndrome |
|
Scientific Title of Study
|
A CLINICAL STUDY TO EVALUATE THE EFFECTIVENESS OF
HOMOEOPATHIC MEDICINES IN CENTESIMAL POTENCY FOR TREATING PREMENSTRUAL SYNDROME USING THE MENSTRUAL DISTRESS
QUESTIONNAIRE |
| 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 SILPA RAVEENDRAN |
| Designation |
PG scholar |
| Affiliation |
Vinayaka Missions Homoeopathic Medical College and Hospital |
| Address |
Department of Organon of Medicine
Opd Room no 2e1
Vinayaka
Missions Homoeopathic Medical College and Hospital
NH47 Sankari Main road Seeragapadi
Salem
Salem
TAMIL NADU
636308
India |
| Phone |
9562596474 |
| Fax |
|
| Email |
silparaveendran1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr PRAVEEN KUMAR A |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
Vinayaka Missions Homoeopathic Medical College and Hospital |
| Address |
Department of Organon of Medicine Opd Room no 2e1
Vinayaka
Mission Homoeopathic Medical College and Hospital
NH47 Sankari
Main road Seeragapadi
Salem
TAMIL NADU
636308
India |
| Phone |
9943445603 |
| Fax |
|
| Email |
praveenbhmsdr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr PRAVEEN KUMAR A |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
Vinayaka Missions Homoeopathic Medical College and Hospital |
| Address |
Department of Organon of Medicine Opd Room no 2e1
Vinayaka
Mission Homoeopathic Medical College and Hospital
NH47 Sankari
Main road Seeragapadi
Salem
TAMIL NADU
636308
India |
| Phone |
9943445603 |
| Fax |
|
| Email |
praveenbhmsdr@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vinayaka Mission Homoeopathic Medical College and Hospital NH47 Sankari Main road
Seeragapadi Salem Tamilnadu |
|
|
Primary Sponsor
|
| Name |
Vinayaka Mission Homeopathic Medical College and Hospital |
| Address |
NH47 Sankari Main road Seeragapadi Salem Tamilnadu 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 SILPA RAVEENDRAN |
VINAYAKA MISSIONS HOMOEOPATHIC MEDICAL COLLEGE AND HOSPPITAL |
Department of Organon of medicine, OPD Room No 2e1, Vinayaka missions homoeopathic medical college and hospitals, NH 47 Sankari Main Road, Seeragapadi 636308
Salem
TAMIL NADU |
9562596474
silparaveendran1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Commitee Vinayaka Mission 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: N943||Premenstrual tension syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathic Medicine |
Homoeopathic Medicines are selected based on Symptom similarity. The Potency is selected based upon the individualisation and susceptibility of the patient. One dose of Medicine is administered orally at the start of treatment, and the follow-up is taken once a month. The medicine will be repeated if the symptoms are not relieved, and follow-up will be continued for six months. |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Women of age group 18-40 years
Women with regular menstrual cycles |
|
| ExclusionCriteria |
| Details |
Patients who have not consented for the study will be excluded.
Pregnant females
Lactating mothers
Women taking oral contraceptive pills.
Patient who are under any medical treatment for major depressive disorder,
premenstrual dysphoric disorder, Poly cystic ovarian disease, uterine fibroid are
excluded. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the effect of Homoeopathic treatment on Pre Menstrual Syndrome. |
15 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The prevalence of pre-menstrual syndrome in females aged 18-40 years. |
15 months |
| The efficacy of the centesimal scale in managing Pre-menstrual syndrome. |
15 months |
| To assess the levels of symptomatic improvement in the MENSTRUAL DISTRESS QUESTIONNAIRE (MEDI-Q) |
15 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/03/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
The pre-menstrual syndrome (PMS) is a common condition among women, characterised by a range
of physical and emotional symptoms that occur in the days leading up to menstruation. PMS can
significantly impact the quality of life of affected individuals. This study aims to assess the
effectiveness of the centesimal potency of homoeopathic medicines in managing PMS symptoms as
diagnosed using a specific questionnaire, namely the PRE-MENSTRUAL SYMPTOM
SCREENING TOOL (PMST).
Pre-menstrual syndrome is defined as cyclically occurring somatic or psychopathological disorders
associated with the existence of the corpus luteum and the influence of ovarian steroid hormone
metabolites on neurotransmitter levels activity.Most women experience psychological and somatic symptoms one or two weeks preceding
menstruation, relieved once the menstruation is established. This group of symptoms include acne,
tender breasts, bloating of the abdomen, tiredness, irritability, and mood changes. Pre-menstrual
syndrome is one of the common discomforts experienced by women during their reproductive life.
PMS is associated with ovulatory menstrual cycles; hence, it may begin after menarche and continue
until ovulation ends at menopause.The study of pre-menstrual syndrome(PMS) appears to have been full of contradictions over many
decades. However, progress in understanding the aetiology and proving therapy for this condition
has accelerated in recent years. It is well known that normal women suffer varying degrees of
discomfort before menstruation.Women (aged 18-40 years) were ensure that their PMS symptoms were severe and that they had
ovulatory menstrual cycles. |