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CTRI Number  CTRI/2025/07/090698 [Registered on: 10/07/2025] Trial Registered Prospectively
Last Modified On: 09/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Other 
Public Title of Study   Studying the Role of Homoeopathic Medicines in Reducing Premenstrual Symptoms in Women 
Scientific Title of Study   Efficacy of individualised homoeopathic medicines in the treatment of premenstrual syndrome assessed by premenstrual syndrome scale (PMSS) -a quasi-experimental time series design. 
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 Silaiezhil M 
Designation  Assistant Professor 
Affiliation  Government Homoeopathic Medical College & Hospital 
Address  Dept of Forensic medicine and Toxicology, Second floor Dr Siddaiah Puranik Road, Basaveshwaranagar,

Bangalore
KARNATAKA
560079
India 
Phone  9449521509  
Fax    
Email  silaiezhil@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rajkumar S Patil 
Designation  Principal, Professor and Guide 
Affiliation  SJPEs Homeopathic Medical College and Hospital 
Address  Dept. of Materia Medica, Ground Floor, 200 E, Tararani Chowk, Kawala Nakap, Kolhapur

Kolhapur
MAHARASHTRA
416003
India 
Phone  7218677677  
Fax    
Email  hmc_h@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Silaiezhil M 
Designation  Assistant Professor 
Affiliation  Government Homoeopathic Medical College & Hospital 
Address  Dept of Forensic medicine and Toxicology, Second floor Dr Siddaiah Puranik Road, Basaveshwaranagar,

Bangalore
KARNATAKA
560079
India 
Phone  9449521509  
Fax    
Email  silaiezhil@gmail.com  
 
Source of Monetary or Material Support  
SJPEs Homeopathic Medical College and Hospital, 200 E,Tararani Chowk, Kawala Nakap, Kolhapur, Maharashtra, Indian. Pin Code- 416003 
 
Primary Sponsor  
Name  Dr Silaiezhil M 
Address  Government Homoeopathic Medical College & Hospital, Dr Siddaiah Puranik Road, Basaveshwaranagar Bangalore Bangalore KARNATAKA 560079 India  
Type of Sponsor  Other [Self] 
 
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 Silaiezhil M  SJPEs Homeopathic Medical College and Hospital,  Dept of Materia Medica, Ground floor, 200 E, Tararani Chowk, Kawala Nakap, Kolhapur
Kolhapur
MAHARASHTRA 		 9449521509

silaiezhil@gmail.com  
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  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 
Intervention  Individualized Homoeopathic medicine.  individualized homoeopathic medicines prescribed based on the totality of the symptoms. Route- Oral, Dose- 4 pills-one dose followed by Placebo- 4 pills/ BD/ Month orally, Duration- 3 months. 
Comparator Agent  Placebo  Non medicated globules Route- Oral, Dose- 4 pills-BD for 3 days / month, Duration- 3 months.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  1) Diagnosed subjects of Premenstrual Syndrome (PMS) as per American College of Obstetrician and gynecology practice bulletin 2001 criteria.
2) Subjects who are voluntarily willing to participate and sign the written informed consent 
 
ExclusionCriteria 
Details  1) Subjects who are on contraceptive pills or any other medications for Premenstrual Syndrome (PMS)
2) Women who are already on Psychiatric medications for depression, anxiety, schizophrenia or any other psychiatric illness.
3) Subjects who are a Known case of PCOD/ Hypothyroidism.
4) Subjects having uterine /ovarian/ pelvic pathology assessed with sonography of pelvis or transvaginal scan.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Change in PMSS (Premenstrual Syndrome Scale) total score from baseline (Month 3) to end of treatment (Month 6).  3 years 
 
Secondary Outcome  
Outcome  TimePoints 
NIl  NIl 
 
Target Sample Size   Total Sample Size="55"
Sample Size from India="55" 
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)   21/07/2025 
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="3"
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  

This quasi-experimental time-series study evaluates the efficacy of individualized homeopathic medicines in treating Premenstrual Syndrome (PMS) among 55 women aged 18-40, diagnosed using ACOG criteria. The study employs a two-phase design: a 3-month placebo phase with monthly Premenstrual Syndrome Scale (PMSS) assessments followed by a 3-month active treatment phase with individualized homeopathic remedies. The primary outcome measures the change in total PMSS scores from baseline to treatment completion, assessing overall symptom severity reduction. The study focuses on core PMS symptoms across physiological, psychological, and behavioral domains while excluding participants on hormonal or psychiatric medications. This design provides longitudinal data on homeopathic treatment effects while maintaining clinical practicality in a real-world setting.


 
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