FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/06/069272 [Registered on: 20/06/2024] Trial Registered Prospectively
Last Modified On: 30/07/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Homeopathy 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Premenstrual Syndrome (PMS) is common conditions affecting women. The symptoms associated with PMS can significantly impact a womans quality of life. aims to contribute to the role of homeopathy has effectiveness in the treatment of PMS. 
Scientific Title of Study   A randomized study for assessing the efficacy of individualized homoeopathic medicines prescribed in 50 millesimal potency and centesimal potency in treatment of patient with pre-menstrual syndrome (PMS) among age group 18 to 25 years 
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 Alpesh Jayswal 
Designation  Assistant Professor 
Affiliation  Parul Institute of Homoeopathy and Research Hospital 
Address  ROOM NO 303 Department of Organon of Medicine Parul Institute of Homoeopathy and Research Hospital, Parul University At- Ishwarpura Post -Limda Waghodia Vadodara Gujarat 391760

Vadodara
GUJARAT
391760
India 
Phone  9978231023  
Fax    
Email  alpeshjaiswal18@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Alpesh Shah 
Designation  Professor, Principal and Guide 
Affiliation  Pioneer Homoeopathic Medical College and Hospital 
Address  201,2nd Floor, Pioneer Homoeopathic Medical College and Hospital At and Post Sayajipura Ajwa Nimeta Road, N.H.No 8 Ajwa,Vadodara 390019

Vadodara
GUJARAT
390019
India 
Phone  9825487564  
Fax    
Email  vrajdev@hotmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Alpesh Jayswal 
Designation  Assistant Professor 
Affiliation  Parul Institute of Homoeopathy and Research Hospital 
Address  ROOM NO 303 Department of Organon of Medicine Parul Institute of Homoeopathy and Research Hospital, Parul University At- Ishwarpura Post -Limda Waghodia Vadodara Gujarat 391760

Vadodara
GUJARAT
391760
India 
Phone  9978231023  
Fax    
Email  alpesh.jaiswal18@gmail.com  
 
Source of Monetary or Material Support  
Parul Institute of Homoeopathy and Research Hospital, Parul University At- Ishwarpura Post -Limda Waghodia Vadodara Gujarat 391760 
 
Primary Sponsor  
Name  Dr Alpesh Jayswal 
Address  ROOM NO 303 Department of Organon of Medicine Parul Institute of Homoeopathy and Research Hospital, Parul University At- Ishwarpura Post -Limda Waghodia Vadodara Gujarat Pincode 391760 
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 Alpesh Jayswal  Parul Institute of Homoeopathy and Research Hospital  101-E Obstetric and Gynecology
Vadodara
GUJARAT 		 9978231023

alpeshjaiswal18@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Parul Institute of Homoeopathy and Research Hospital  No Objection Certificate 
Smt Malini Kishore Sanghvi Homoeopathic Medical College and Hospital 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 
Comparator Agent  Individualized Homeopathic Medicines For Example Platina, Pulsatilla, Magnesium Phos etc  50 Millesimal Potency for example 0/1, 0/2 etc BD for 30 Days 
Intervention  Individualized Homeopathic Medicines For Example Platina, Pulsatilla, Magnesium Phos etc  Individualized Homeopathic Medicines given in Centisimal Potency for example 30,200,1M BD For 30 Days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  25.00 Year(s)
Gender  Female 
Details  1 Cases suffering from PMS.
2 Age between 18 to 25 years
3 PMS Diagnosed cases with Pre-Menstrual syndrome Scale (PMSS) Score is 80 or above 80.
4 Willingness to Participate Participants who provide informed consent and are willing to comply with the study requirements, including attending scheduled visits and following the prescribed treatment regimen. 
 
ExclusionCriteria 
Details  1 Married Women
2 Participants with Menstrual irregularities like Leucorrhoea, Dysmenorrhoea, Menorrhoea ,Metrorrhagea, PCOS
3 Medical Conditions Participants with severe medical conditions or comorbidities that may interfere with the assessment of PMS symptoms or pose a risk to their well-being.
4 Psychiatric Disorders Participants with severe psychiatric disorders, such as major depressive disorder or bipolar disorder, which may require alternative treatment approaches.
5 Hormonal Treatment Participants currently receiving or planning to initiate hormonal treatments specifically for PMS during the study period, as this may confound the evaluation of homoeopathic treatment efficacy.
6 Previous Homoeopathic Treatment Participants who have received homoeopathic treatment for PMS within a defined period (e.g 3 months) prior to the study initiation.
7 Allergy or Sensitivity Participants with known allergies or sensitivities to homoeopathic medicines or their components.
8 Substance abuse and/or dependence
9 Diagnosed or suspected cases of any malignancy
10 Patients taking Allopathic or any other systemic medicine 
 
Method of Generating Random Sequence   Adaptive randomization, such as minimization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Efficacy of individualized Homoeopathic Medicine in patient of pre-menstrual syndrome (PMS) among age group 18 to 25 years.  Study Duration 1 Year.
Follow up at every Month for 3 menstrual Cycle.
Intervention of Pre-Menstrual syndrome Scale (PMSS)at Every 3 months for assessing the score after giving individualized Homoeopathic Medicines in 50 millesimal and Centesimal Scale.  
 
Secondary Outcome  
Outcome  TimePoints 
50 millesimal Potency and Centesimal Potency among this which Scale have more Significant improvement seen in treatment with Patient of pre-menstrual syndrome (PMS) among age group 18 to 25 years?  1 Year 
To listed potencies, which are more frequently used for Significant improvement seen in Patient of pre-menstrual syndrome (PMS) among age group 18 to 25 years of Centesimal Scale and 50 millesimal Scale.  1 Year 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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 2/ Phase 3 
Date of First Enrollment (India)   01/07/2024 
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="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
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 common conditions affecting women during the luteal phase of their menstrual cycle. The symptoms associated with these conditions can significantly impact a woman’s quality of life.Conventional medical treatments for PMS often involve the use of hormonal therapies and antidepressants, but their efficacy and potential side effects have raised concerns among patients and healthcare providers. As a result, there is growing interest in alternative and complementary therapies, such as homeopathy.This study aims to assess the efficacy of individualized homeopathic medicines prescribed in 50 millesimal potency and centesimal potency in the treatment of patients with PMS. 
Close