| CTRI Number |
CTRI/2024/04/065119 [Registered on: 02/04/2024] Trial Registered Prospectively |
| Last Modified On: |
21/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy
Other (Specify) [Melatonin Supplements] |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Yoga can be an effective intervention for shift workers to cope with sleep-related problems. |
|
Scientific Title of Study
|
Effect of Yoga on Melatonin Secretion and Associated Psycho-Physiological Parameters among Shift Workers: 3-Arm Randomized Control 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 |
Anupa Chhantyal |
| Designation |
Lecturer |
| Affiliation |
S-VYASA deemed to be University |
| Address |
S-VYASA Deemed to be University
Prashanti Kutiram, Bengaluru, Karnataka
Bangalore
KARNATAKA
560105
India |
| Phone |
8861484382 |
| Fax |
|
| Email |
anupa.chhantyal@svyasa.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Anupa Chhantyal |
| Designation |
Lecturer |
| Affiliation |
S-VYASA deemed to be University |
| Address |
S-VYASA Deemed to be University
Prashanti Kutiram, Bengaluru, Karnataka
KARNATAKA
560105
India |
| Phone |
8861484382 |
| Fax |
|
| Email |
anupa.chhantyal@svyasa.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Anupa Chhantyal |
| Designation |
Lecturer |
| Affiliation |
S-VYASA deemed to be University |
| Address |
S-VYASA Deemed to be University
Prashanti Kutiram, Bengaluru, Karnataka
KARNATAKA
560105
India |
| Phone |
8861484382 |
| Fax |
|
| Email |
anupa.chhantyal@svyasa.edu.in |
|
|
Source of Monetary or Material Support
|
| S-VYASA Deemed to be University
Prashanti Kutiram, Kalluballu Post, Jigani Hobli, Anekal Taluk, Bengaluru-560105 |
|
|
Primary Sponsor
|
| Name |
SVYASA Deemed to be University |
| Address |
Anvesna Lab
S-VYASA Deemed to be University
Prashanti Kutiram, Kalluballu Post, Jigani Hobli, Anekal Taluk, Bengaluru-560105 |
| 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 B R Ramakrishna |
Maini Precision Products |
Maini Precision Products Ltd.
Unit- Bommasandra Auto 5A
#5A, Bommasandra, Industrial Area, Bangalore-560099
Bangalore
KARNATAKA |
9902543943
athreyahealthparadise@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC)-Swami Vivekananda Yoga Anusandhana Samsthana |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Shift Workers having Sleep Problems |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Melatonin supplements |
.25 mg 5 days per week for 12 weeks. 30-45 min. before bedtime (After screening physician will prescribe the need of a supplement to participants of the comparator group).
|
| Intervention |
Yoga Module for Shift Worker |
Yoga practice for 45 minutes, 5 days a week for 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
24.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Screened positive for shift work disorder screening Questionnaire
|
|
| ExclusionCriteria |
| Details |
Addicted to smoking and drinking
(Habitual, Occasional, and social is not excluded)
Taking any alternative methods of relaxation one week before screening
(sedatives, massage, aromatherapy, etc.)
Screened negative for shift work disorder
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Melatonin
Sleep (quality, sleep onset, sleep quantity) |
MELATONIN
Baseline
12 weeks
SLEEP
Baseline
8 Weeks
12 Weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Oxidative stress test
C-Reactive Protein
Erythrocyte Sedimentation Rate
HRV
|
Baseline & 12 Weeks |
Blood pressure
Heart rate
BMI
QOL
Mood
Stress
Prakriti
Gastrointestinal disorder
|
Baseline, 8 Weeks, And 12 Weeks |
|
|
Target Sample Size
|
Total Sample Size="156"
Sample Size from India="156"
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)
|
15/04/2024 |
| 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="0"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [anupa.chhantyal@svyasa.edu.in].
- For how long will this data be available start date provided 08-09-2024 and end date provided 28-01-2050?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Namaste, The research study is on shift workers. Shift worker’s biological clock is hampered because of different working hours. In the long run that will become the source of comorbidities like diabetes, cardiovascular problems, and even cancer. To cope with the problem we have only melatonin supplements that too for short periods. Yoga is an alternative therapy for different ailments and also shows promising results in sleep problems hence study would be beneficial for the solution of jeopardized shift worker health problems.
I have been working on this project for so long however due to funding and sample source issues I was not able to proceed further. Now, that my problem is solved I am willing to address the shift worker’s health problem which has been there for so long.
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