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CTRI Number  CTRI/2024/12/078405 [Registered on: 20/12/2024] Trial Registered Prospectively
Last Modified On: 17/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Enhancing Wellness and Quality of Life: Transdermal Magnesium for College Females with Menstrual Pain 
Scientific Title of Study   Role of transdermal magnesium to improve functional quality of life and wellness among collegiate females with Primary Dysmenorrhea- A randomized controlled trial. 
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 Jyoti Sharma 
Designation  Professor 
Affiliation  Galgotias University 
Address  Room No. E004, Department of Physiotherapy,Galgotias University, Plot No. 02, Sector 17-A Yamuna Expressway, Greater Noida,Gautam Buddh Nagar Gautam Buddha Nagar UTTAR PRADESH 203201 India

Gautam Buddha Nagar
UTTAR PRADESH
203201
India 
Phone  9717161626  
Fax    
Email  jyoti.sharma@galgotiasuniversity.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Devika Sunil 
Designation  Student 
Affiliation  Galgotias University 
Address  Room No. E005, Department of Physiotherapy,Galgotias University, Plot No. 02, Sector 17-A Yamuna Expressway, Greater Noida,Gautam Buddh Nagar Gautam Buddha Nagar UTTAR PRADESH 203201 India

Gautam Buddha Nagar
UTTAR PRADESH
203201
India 
Phone  9990988805  
Fax    
Email  devikasunil144@gmail.com  
 
Details of Contact Person
Public Query  
Name  Devika Sunil 
Designation  Student 
Affiliation  Galgotias University 
Address  Room No. E005, Department of Physiotherapy,Galgotias University, Plot No. 02, Sector 17-A Yamuna Expressway, Greater Noida,Gautam Buddh Nagar Gautam Buddha Nagar UTTAR PRADESH 203201 India

Gautam Buddha Nagar
UTTAR PRADESH
203201
India 
Phone  9990988805  
Fax    
Email  devikasunil144@gmail.com  
 
Source of Monetary or Material Support  
Research and Development cell, Galgotias University, Plot No2, Sector 17A, Opposite Yamuna Expressway, Greater Noida, Gautam Buddha Nagar UTTAR PRADESH 203201 India 
 
Primary Sponsor  
Name  Galgotias University 
Address  Room No B-315, Galgotias University Plot No 2, Sector 17A, Opposite Buddha International Circuit, Greater Noida 203201 
Type of Sponsor  Research institution 
 
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 Jyoti Sharma  Galgotias University  Room No. E004, Department of Physiotherapy,Galgotias University, Plot No. 02, Sector 17-A Yamuna Expressway, Greater Noida,Gautam Buddh Nagar Gautam Buddha Nagar UTTAR PRADESH 203201 India
Gautam Buddha Nagar
UTTAR PRADESH 		 09717161626

jyoti.sharma@galgotiasuniversity.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Departmental Research Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N944||Primary dysmenorrhea,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Core and pelvic stability exercises   An informed consent will be signed by all the participants. Hot fomentation will keep for 10 minutes. Followed by physiotherapy treatment during menstrual cycle for 6 months. Standard physiotherapy care includes core stability exercises and pelvic floor strengthening exercises for 10 repititions with 5 seconds of hold and 10 seconds of relaxation time for primary dysmenorrhea. 
Intervention  Transdermal Magnesium  An informed consent will be signed by all the participants. Transdermal magnesium will be given as spray applied to the abdomen and lower back with 3-5sprays with a gap of 1-2 minutes, twice a day during menstrual cycle for 6 months and standard physiotherapy care includes core stability exercises and pelvic floor strengthening exercises for 10 repititions with 5 seconds of hold and 10 seconds of relaxation time. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  30.00 Year(s)
Gender  Female 
Details  Participants must be females aged 18-30 with primary dysmenorrhea and a WALLID score above a specified threshold. They should be willing to provide informed consent, attend intervention sessions, and complete follow-up assessments. Participants must also be able to understand and communicate in the study language, follow instructions, and complete questionnaires. A negative patch test with no irritation or burning from transdermal magnesium application is required. 
 
ExclusionCriteria 
Details  Participants will be excluded if they have a history of secondary dysmenorrhea (e.g., due to endometriosis or pelvic inflammatory disease), a WALLID score below a specified threshold, or are pregnant or planning to become pregnant during the study. Those using hormonal contraceptives or medications affecting the menstrual cycle or pain perception within a specified time frame are also excluded. Individuals with a history of chronic pelvic pain, psychiatric disorders, or current use of psychotropic medications are not eligible. Participation in other dysmenorrhea-related interventions or clinical trials during the study period is prohibited. Other exclusions include inability to comply with the protocol, medical conditions that pose safety risks, known allergies to magnesium or components of the transdermal formulation, and physical limitations preventing participation in pelvic floor exercises. Participants who experience itching or burning during the patch test will also be excluded. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The main primary outcome to be assess will be menstrual pain on Wallid scale, functional activities of daily living with Barthel index scale and mental well-being by WHO-5 scale.  Baseline (day 1) once a month during menstrual cycle for 6 months and once a month follow up for 3 months  
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="72"
Sample Size from India="72" 
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 
Date of First Enrollment (India)   02/01/2025 
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="0"
Months="3"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [jyoti.sharma@galgotiasuniversity.edu.in].

  6. For how long will this data be available start date provided 18-04-2025 and end date provided 31-10-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Primary dysmenorrhea (PD) is a common condition characterized by painful menstruation, typically involving suprapubic cramps radiating to the back and thighs. It is not associated with pelvic disease and typically begins after menarche, affecting 50-90% of women. PD can negatively impact quality of life (QoL), influencing daily activities, social interactions, and emotional well-being. The exact cause is not fully understood, but it is thought to involve increased prostaglandin release, which leads to uterine muscle contractions and pain.

Magnesium has been suggested to reduce dysmenorrhea symptoms by acting as an analgesic and by influencing the NMDA receptor, reducing central sensitization and pain perception. However, while there has been research on magnesium and other treatments for PD, the specific role of transdermal magnesium has not been well-studied, particularly in improving QoL.

Aim and Objectives: The aim of this study is to analyze the role of transdermal magnesium in improving functional QoL among college females with primary dysmenorrhea.

Methodology:

Study Design: Randomized, parallel group, active-controlled trial with a pre-post interventional design.
Study Site: Galgotias University OPD E-Block.
Sample Size: 72 participants, calculated using G Power with a 10% dropout rate.
Screening: Self-structured questionnaire and WALLID Score to assess dysmenorrhea; patch test prior to intervention.
Research Gap: While magnesium’s role in dysmenorrhea has been studied, the specific impact of transdermal magnesium on primary dysmenorrhea and its effect on QoL remains under-researched.

Transdermal Magnesium Uses: Magnesium is believed to have various benefits, including aiding in muscle recovery, joint pain relief, PMS, and menstrual pain management. Regular use of transdermal magnesium can help alleviate cramps and other dysmenorrhea symptoms, potentially improving overall wellness.

This study will contribute to filling the research gap by evaluating the effectiveness of transdermal magnesium in managing primary dysmenorrhea and its impact on quality of life. 
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