| CTRI Number |
CTRI/2025/05/086469 [Registered on: 07/05/2025] Trial Registered Prospectively |
| Last Modified On: |
06/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of yoga on stress, immunity and sleep in menstrual cycle |
|
Scientific Title of Study
|
Effects of Short-term Yoga-based Lifestyle Intervention on Stress, Immunity and Sleep Rhythmicity in Follicular & Luteal Phase of Menstrual Cycle: 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 Raj Kumar Yadav |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Room no. 2004 2nd floor, Dept. of Physiology, Teaching block All India Institute of Medical Sciences, New Delhi
South
DELHI
110029
India |
| Phone |
9811319057 |
| Fax |
|
| Email |
raj3kr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Raj Kumar Yadav |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Room no. 2004 2nd floor, Dept. of Physiology, Teaching block All India Institute of Medical Sciences, New Delhi
South
DELHI
110029
India |
| Phone |
9811319057 |
| Fax |
|
| Email |
raj3kr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Riya Sen |
| Designation |
M.Sc Student |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Room No 2035, Integral Health And Wellness Clinic, 2nd floor, Dept. of Physiology, Teaching block All India Institute of Medical Sciences, New Delhi
South
DELHI
110029
India |
| Phone |
9306747405 |
| Fax |
|
| Email |
riyasen12122001@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute Of Medical Sciences, New Delhi, 110029, India |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences, New Delhi |
| Address |
All India Institute of Medical Sciences, New Delhi |
| Type of Sponsor |
Research institution |
|
|
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 |
| Dr Raj Kumar Yadav |
AIIMS, New Delhi |
Room no 2035, Integral Health and wellness Clinic, Teaching Block, 2nd floor, Department of Physiology, AIIMS, New Delhi
South
DELHI |
26546461
raj3kr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee for Post Graduate Research |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
No intervention group |
Blood Sampling done at baseline, 2 weeks, 4 weeks and 6 weeks. |
| Intervention |
Yoga Based Lifestyle Intervention Group |
A structured yoga program focusing on physical postures (asana), breathing exercises (pranayama) and meditation.
5 sessions per week for 2 weeks at integral health & wellness clinic (IHC), Dept of Physiology, AIIMS New Delhi, under the direct supervision of yoga therapist. Each session approx. 60 minutes. The participants in this group will be advised to follow the same practices at their home during the next menstrual cycle(s) as well.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1.Regular menstrual cycle, varying from 24-32days
2.Menstrual phase lasting upto 7 days
3.Menstrual product use: Three to six pads or tampons per day
4.Flow volume should be normal
5.No intermenstrual bleeding
6.No prior yoga intervention in last 8 weeks |
|
| ExclusionCriteria |
| Details |
1.History of any gynecological disorders including PCOS
2.Use of oral contraceptive pills
3.Any thyroid disorders, or immune disorders, autoimmune disorders
4.Substance abuse
5.Any diagnosed sleep disorders
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the effects of short-term YBLI in follicular and luteal phase of regular menstrual cycle on:
1.Immunity : T cell,B cell,NK cell
2.Stress : Cortisol
3.Sleep : Melatonin |
There will be 4 time points: at baseline, after 2 weeks, 4 weeks and 6 weeks . |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To correlate the stress, sleep and immunity parameters with phases of menstrual cycle and premenstrual symptoms of the participants. |
There will be 4 time points: at baseline, after 2 weeks, 4 weeks and 6 weeks . |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
20/05/2025 |
| 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="10"
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
|
Menstrual cycle is a repetitive phenomenon occurring every 21-45 days during the reproductive life of a female that involves structural, functional & hormonal changes in the reproductive system. The follicular and luteal phases of the menstrual cycle involve significant hormonal fluctuations, which impact stress levels, sleep patterns, and immune function. Understanding how yoga-based interventions affect these changes can offer non-pharmacological solutions for better health management. Yoga is known to influence the hypothalamic-pituitary-adrenal (HPA) axis, which regulates stress and immunity. Investigating its effects in the context of the menstrual cycle helps establish a connection between lifestyle practices and hormonal health. Women often report disturbed sleep during different phases of their cycle. Yoga’s potential to enhance sleep quality could provide significant insights into managing menstrual-related sleep issues. Hormonal shifts during the menstrual cycle can impact immunity. This study may provide evidence of yoga’s role in strengthening or stabilizing immune responses during these phases. By targeting specific phases of the menstrual cycle, the research could lead to phase-specific lifestyle recommendations, contributing to the field of personalized medicine and holistic health. The study could validate yoga as an effective, low-cost, and non-invasive method to manage stress, improve sleep, and enhance immunity, benefiting a wide range of individuals. This study addresses a critical gap in understanding how lifestyle interventions can improve overall well-being in the context of menstrual cycle-related changes.
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