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CTRI Number  CTRI/2025/11/097462 [Registered on: 14/11/2025] Trial Registered Prospectively
Last Modified On: 14/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   How Intermittent Fasting Affects on Premenstrual Syndrome in medical students 
Scientific Title of Study   IMPACT 0F INTERMITTENT FASTING ON PREMENSTRUAL SYNDROME AMONG MEDICAL STUDENTS - A RANDOMIZED CONTROLLED TRIAL 
Trial Acronym  RCT 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Gayathri B 
Designation  MD Scholar 
Affiliation  Alvas college of naturopathy and yogic sciences 
Address  Room Number 09 Department of clinical naturopathy Alvas college of naturopathy and yogic sciences Mijar Moodbidri Dakshina kannada KARNATAKA 574225 India

Dakshina Kannada
KARNATAKA
574225
India 
Phone  9061680001  
Fax    
Email  gayathri1998b@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vineetha A N 
Designation  Associate Professor Guide 
Affiliation  Alvas college of naturopathy and yogic sciences 
Address  Room Number 09 Department of clinical naturopathy Alvas college of naturopathy and yogic sciences Mijar Moodbidri Dakshina kannada KARNATAKA 574225 India

Dakshina Kannada
KARNATAKA
574225
India 
Phone  8861064135  
Fax    
Email  Vineethabnys@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Swathi S 
Designation  Assistant Professor Co-Guide 
Affiliation  Alvas college of naturopathy and yogic sciences 
Address  Room Number 09 Department of clinical naturopathy Alvas college of naturopathy and yogic sciences Mijar Moodbidri Dakshina kannada KARNATAKA 574225 India

Dakshina Kannada
KARNATAKA
574225
India 
Phone  8073765371  
Fax    
Email  drswathi1997@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Dr Gayathri B 
Address  Alvas college of naturopathy and yogic sciences Tenkamijar shobhavana campus moodbidri 
Type of Sponsor  Other [Self Sponsor] 
 
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 
Gayathri B  Alvas college of naturopathy and yogic sciences  Room Number 03 Department of clinical Naturopathy, Alvas college of naturopathy and yogic sciences
Dakshina Kannada
KARNATAKA 
09061680001

gayathri1998b@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical committee for Human Studies of Alvas College of Naturopathy and Yogic Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  PREMENSTRUAL SYNDROME 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Intermittent Fasting  20:4 Hours window of Intermittent Fasting starting from 9th day of menstrual cycle till 28th day for 2 months. 
Comparator Agent  No intervention : will be asked to follow daily routine  Control group is not given any interventions but they are asked to follow the daily routine what they were following earlier 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  28.00 Year(s)
Gender  Female 
Details  Mild and moderate level of students are categorized under psst assessment, and Medical students are taken for study. Individuals with a regular menstrual cycle, by their own willingness and priorly they should sign in a consent form 
 
ExclusionCriteria 
Details  Thyroid conditions, low blood pressure, Gastric issues, psychological issues, Premenstrual dysphoric disorder (PMDD), any other gynecological issues, Students under any medications, Students having night duties, and extra hour work 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Premenstrual Symptoms Screening tool - PSST  Pre assessment- on the 4th day of menstrual cycle
Post assessment - on the next month 4th day of menstrual cycle  
 
Secondary Outcome  
Outcome  TimePoints 
Menstrual discomfort Questionnaire (MEDI-Q)  Less than mild 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   14/12/2025 
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="7"
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  

To evaluate the effect on Two months modified Intermittent fasting for premenstrual syndrome on medical students. Intermittent fasting using a 20:4 hour protocol 20 hours of fasting followed by a 4 hour eating window may help reduce symptoms of premenstrual syndrome PMS, potentially by improving mitochondrial and other systemic functions in the body.Intermittent fasting has shown positive effects on mitochondrial health, which is crucial for efficient cellular energy production and overall metabolic function. Mechanisms includePromotion of mitochondrial fusion via sirtuin activation.Enhanced mitophagy and turnover.Reduction in oxidative stress and improved overall cellular energetic balance.These effects help the body repair and optimize vital functions, potentially alleviating common PMS symptoms like fatigue, mood swings, and pain, which are partly linked to mitochondrial dysfunction. Also The gut microbiota plays a significant role in the gastrointestinal system, where dietary tryptophan is mostly converted to serotonin. 20:4 fasting can improve metabolic flexibility by increasing insulin sensitivity and reducing inflammation. For premenopausal women, particularly those with obesity or hormonal disturbances intermittent fasting may lower androgen levels , increase sex hormone-binding globulin . It does not significantly affect estrogen or gonadotropin levels, but when food is consumed earlier in the day, benefits for androgen markers were most evident.
 

 
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