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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.


 
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