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CTRI Number  CTRI/2025/10/095774 [Registered on: 09/10/2025] Trial Registered Prospectively
Last Modified On: 08/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   Study to check how homeopathy prospective intervention method can help women with premenstrual syndrome (PMS) improve their quality of life. 
Scientific Title of Study   Study of premenstrual syndrome and its management from synthesis repertory using PMSS scale 
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 Urvi Makwana  
Designation  PG scholer  
Affiliation  Anand Homoeopathic Medical College and Research Institute 
Address  Department Of Gynecology And Obstetrics OPD No 1, Room No 3 Opp. Sardar Baug, Nr New Bus Stand, Anand - 388001 Anand GUJARAT

Anand
GUJARAT
388001
India 
Phone  9714084290  
Fax    
Email  urvimakwana661@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Abhishek udani  
Designation  MD homeopathy proffessor of department of homeopathy repertory and case taking 
Affiliation  Anand Homoeopathic Medical College and Research Institute 
Address  A-7,Shree Krishna Society, B/H Mira Park, 80 Feet Road, Anand 388001

Anand
GUJARAT
388001
India 
Phone  9978624694  
Fax    
Email  udaniabhishek@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Abhishek udani  
Designation  Md homeopathy Professor of department homeopathy repertory and case taking  
Affiliation  Anand Homoeopathic Medical College and Research Institute 
Address  Room no 213 department of homeopathy repertory and case taking 1st floor Anand Homeopathic Medical College and Research Institute near Sardar Baug Bhalej road Anand Anand GUJARAT 388001 India

Anand
GUJARAT
388001
India 
Phone  9978624694  
Fax    
Email  udaniabhishek@gmail.co  
 
Source of Monetary or Material Support  
Anand homoeopathic and general hospital, opposite sardar baug, near new Bus station, anand 388001. 
 
Primary Sponsor  
Name  Dr Urvi Makwana  
Address  Babariya main road morari nagar 5 rajkot 360002 
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 Urvi Makwana  Anand homoeopathic general hospital Opposite sardar baug, near new Bus station, anand.388001  OPD no.1, room no. 3 gynaecology and obstetrics department, Anand homoeopathic and general hospital.
Anand
GUJARAT 		 9714084290

urvimakwana661@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical 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  Individualised homoeopathic medicine according to repertorial totality   Each case will be repertorized by synthesis repertory 9.1 . Dose and frequency of medicine will be according to guidelines given by hahnemann in posology. Route of administration is Oral Duration of intervention will be 15 days, 1 month or on the demand of case during follow up. 
Comparator Agent  Not applicable as there is no comparator agents  Not applicable  
 
Inclusion Criteria  
Age From  14.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  Women diagnosed with premenstrual syndrome (PMS).
Age group: typically women aged 14-45 years
No history of other gynaecological disorders or serious comorbidities
that could affect PMS symptoms.
 
 
ExclusionCriteria 
Details  Exclusion criteria:-
Women with severe psychiatric disorders (eg schizophrenia, bipolar
disorder).
Women undergoing hormonal therapy or other medications that could

interfere with PMS symptoms.
• Women aged before 14 and after 45.
• Women with other gynaecological disease ,pregnancy, or breast
feeding women. 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Improvement in PMSS scale before and after treatment   Before and after treatment  
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in PMSS scale before and after treatment   Every follow up like 15th day, 1 month... 
 
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)   21/10/2025 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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   Premenstrual Syndrome (PMS) is a common cyclic disorder affecting women of reproductive age, characterized by physical, emotional, and behavioral symptoms occurring in the luteal phase of the menstrual cycle and subsiding with menstruation. The Premenstrual Syndrome Scale (PMSS) is a standardized, self-report instrument used to assess the severity and frequency of PMS symptoms across multiple domains, including psychological (irritability, anxiety, depression), physical (bloating, breast tenderness, headache), and behavioral changes (sleep disturbances, appetite changes, social withdrawal).

Research using the PMSS aims to:

Quantify prevalence and severity of PMS among study populations.

Identify symptom patterns and dominant clusters across different demographic and clinical groups.

Evaluate associations with lifestyle, stress, diet, and comorbidities.

Assess treatment efficacy (pharmacological, homoeopathic, or lifestyle interventions) by comparing pre- and post-intervention PMSS scores.


The PMSS thus provides a reliable, multidimensional tool for both clinical assessment and research, facilitating early identification, proper management, and evaluation of outcomes in women experiencing PMS.
 
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