| CTRI Number |
CTRI/2025/08/093033 [Registered on: 13/08/2025] Trial Registered Prospectively |
| Last Modified On: |
12/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to find out how well homoeopathy helps women feel better before and during their menses |
|
Scientific Title of Study
|
Effectiveness of Constitutional Homoeopathic Treatment in Managing Pre-Menstrual Syndrome -A Clinical Study |
| 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 AMRITHA K |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
Sarada Krishna Homoeopathic Medical College and Hospital |
| Address |
Room no 403, 3rd floor, College Building, Department of Organon of Medicine and Homoeopathic Philosophy, Sarada Krishna Homoeopathic Medical College, Kulasekharam, Kanniyakumari District
Kanniyakumari TAMIL NADU 629161 India |
| Phone |
8754438049 |
| Fax |
|
| Email |
amrithaanilkumar2000@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr M MURUGAN |
| Designation |
PROFESSOR AND HEAD |
| Affiliation |
Sarada Krishna Homoeopathic Medical College and Hospital |
| Address |
Room no 403, 3rd floor, College Building, Department of Organon of Medicine and Homoeopathic Philosophy, Sarada Krishna Homoeopathic Medical College, Kulasekharam, Kanniyakumari District
Kanniyakumari TAMIL NADU 629161 India |
| Phone |
9443343707 |
| Fax |
|
| Email |
drmmuruganhomoeo@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr M MURUGAN |
| Designation |
PROFESSOR AND HEAD |
| Affiliation |
Sarada Krishna Homoeopathic Medical College and Hospital |
| Address |
Room no 403, 3rd floor, College Building, Department of Organon of Medicine and Homoeopathic Philosophy, Sarada Krishna Homoeopathic Medical College, Kulasekharam, Kanniyakumari District
Kanniyakumari TAMIL NADU 629161 India |
| Phone |
9443343707 |
| Fax |
|
| Email |
drmmuruganhomoeo@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sarada Krishna Homoeopathic Medical College, Kulasekharam, Kanniyakumari District, Tamilnadu 629161 |
|
|
Primary Sponsor
|
| Name |
Post Graduate Research Funded by College |
| Address |
Sarada Krishna Homoeopathic Medical College, Kulasekharam, Kanniyakumari District, Tamilnadu 629161 |
| 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 AMRITHA K |
Sarada Krishna Homoeopathic Medical College |
Department of Organon of Medicine, OPD,IPD , Rural Health Centres, Sarada Krishna Homoeopathic Medical College, Kulasekharam, Kanniyakumari District, Tamilnadu 629161 Kanniyakumari TAMIL NADU |
08754438049
amrithaanilkumar2000@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE SARADA KRISHNA HOMOEOPATHIC MEDICAL COLLEGE |
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 |
| Comparator Agent |
Comparator Agent |
This is a Single Arm Interventional Study, So No Comparator Agent is utilised. |
| Intervention |
CONSTITUTIONAL HOMOEOPATHIC TREATMENT |
1. 30 pre-diagnosed Pre-Menstrual Syndrome cases meeting the inclusion criteria will be selected.
2. Cases will be recorded in the pre-structured case format of Sarada Krishna Homoeopathic Medical College.
3. Intervention will be provided based on Each patient’s constitution (mental, emotional, and physical attributes) will be analyzed along with Pre-Menstrual Syndrome symptoms.
4. Intervention will be given on Day 18 (on a Average 28 day Cycle) calculated accordingly for short and long cycles.
8. Additionally , their progress is tracked through Pre-Assessment and Post - Assessment, recorded using Premenstrual Syndrome Assessment Scale(PMSS) every Month
|
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Aged 12 to 40 years
Nulliparous women
Premenstrual Syndrome diagnosed based on American College of Obstetricians and Gynecologists diagnostic criteria.
Symptoms should be cyclical, occurring in the luteal phase 5 to 10 days before menstruation and resolving within 4 days of menstrual onset for at least three consecutive menstrual cycles.
Regular menstrual cycles 21 to 35 day
Presence of at least one affective symptom and one somatic symptom
|
|
| ExclusionCriteria |
| Details |
Women above 40 years
Irregular menstrual cycle
Symptoms that persist beyond menstruation or occur inconsistently, indicating non cyclic mood disorders
Diagnosis of Major Depressive Disorder, Generalized Anxiety Disorder, or any other psychiatric illness requiring pharmacological intervention.
Current or recent use within the past three months of hormonal therapy oral contraceptives, hormone replacement therapy or selective serotonin reuptake inhibitors for Pre Menstrual Syndrome.
Nulliparous women with signs of perimenopause, such as hot flashes, night sweats, vaginal dryness, or persistent cycle irregularities.
Presence of gynecological conditions that could mimic Pre Menstrual Syndrome, including endometriosis, adenomyosis, chronic pelvic inflammatory disease, or ovarian cysts.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Effectiveness of Constitutional Homoeopathic Treatment in reducing Pre-Menstrual Syndrome Symptoms
|
6 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Improvement in Quality of Life in Pre-Menstrual Syndrome cases
2.Reduction in the need for Conventional Medications
3.Sustained Symptom Relief across Multiple Menstrual Cycles |
6 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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
25/08/2025 |
| 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="2" Months="0" Days="0" |
|
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
|
A Psychoneuroendocrine disorder of unknown etiology, Premenstrual syndrome (PMS) is characterized by the cyclical occurrence of several symptoms in the final seven to ten days of the menstrual cycle. According to the American College of Obstetricians and Gynecologists’ (ACOG) criteria, it is diagnosed as Pre-Menstrual Syndrome (PMS) when symptoms significantly interfere with day-to-day functioning. About 47.8% of women of reproductive age worldwide suffer from Pre-Menstrual Syndrome. Another known risk factor for postpartum depression is Pre-Menstrual Syndrome. Hormonal changes, stress, diet, and neurotransmitter imbalances—especially those involving aberrant serotonin activity and altered neurosteroid metabolism—are all contributing factors. However, women with and without PMS may have the same absolute hormone levels. The severity of PMS varies from person to person; 30.6% report mild symptoms, 13.6% report moderate symptoms, and 8.1% report severe distress. Women with regular cycles tend to report more symptoms than those with irregular periods. Even though PMS is very common and has a big influence on public health, the Global Burden of Disease (GBD) model predicts that each woman with severe PMS will be disabled for about 3.835 years. Despite the use of vitamin/mineral supplements (62%), exercise (59%), natural progesterone (51%), dietary changes (44%), antidepressants (15%), and anxiolytics (10%), only about one-third of women say they are satisfied with the treatments they have received. In light of these restrictions, the purpose of this clinical study is to assess how well constitutional homeopathic treatment can control Pre-Menstrual Syndrome and enhance quality of life. Pre-Menstrual Syndrome symptoms, each patient’s mental, emotional, and physical constitution will be examined. Based on the sum of their symptoms, a suitable homeopathic remedy will be selected and medications will be given on Day 18 of the typical 28-day cycle, calculated based on longer and shorter cycles accordingly. The Premenstrual Syndrome Assessment Scale (PMSS) will be used to evaluate progress every month to assess the reduction in the Pre-Menstrual Symptoms. |