| 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
|
|
|
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
|
|
|
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
|
|
|
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. |