| CTRI Number |
CTRI/2023/05/052212 [Registered on: 02/05/2023] Trial Registered Prospectively |
| Last Modified On: |
27/04/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Add-on effect of Ayurvedic module on Anti-inflammatory markers in night shift workers |
|
Scientific Title of Study
|
A RANDOMIZED CONTROLLED TRIAL TO EVALUATE THE ADD-ON EFFECT OF AYURVEDIC MODULE ON ANTI-INFLAMMATORY CYTOKINE IL-10 IN NIGHT SHIFT WORKERS |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pankaj Kumar |
| Designation |
PhD Scholar |
| Affiliation |
All India Institute of Ayurveda New Delhi |
| Address |
Department of Swasthavritta, All India Institute of Ayurveda, Mathura Road,Gautampuri, Sarita Vihar, New Delhi-110076
South
DELHI
110076
India |
| Phone |
7876317882 |
| Fax |
|
| Email |
dr.pankaj86@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shivakumar S Harti |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Ayurveda New Delhi |
| Address |
Associate Professor Department of Swasthavritta, All India Institute of Ayurveda, Mathura Road, Gautampuri, Sarita Vihar, New Delhi-110076
South
DELHI
110076
India |
| Phone |
9611275434 |
| Fax |
|
| Email |
shivakumarsharti@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pankaj Kumar |
| Designation |
PhD Scholar |
| Affiliation |
All India Institute of Ayurveda New Delhi |
| Address |
Department of Swasthavritta, All India Institute of Ayurveda, Mathura Road,Gautampuri, Sarita Vihar, New Delhi-110076
South
DELHI
110076
India |
| Phone |
|
| Fax |
|
| Email |
dr.pankaj86@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Ayurveda New Delhi |
|
|
Primary Sponsor
|
| Name |
All India Institute of Ayurveda New Delhi |
| Address |
Mathura Road Gautampuri Sarita Vihar New Delhi |
| Type of Sponsor |
Other [An Autonomous Organisation under the Ministry of AYUSH Govt of India] |
|
|
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 Pankaj Kumar |
All India Institute of Ayurveda |
room no 603, Academic Block, 6th floor, All India Institute of Ayurveda, Gautampuri, Sarita Vihar, New Delhi-110076
South
DELHI |
7876317882
dr.pankaj86@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Human Volunteers having night shift duty. |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Lifestyle | - | - | Dinacarya: , Ritucarya: , Acara Rasayana:, Other:YOGA MODULE : Participants enrolled in the Group A will be intervened through Yoga Module for that training will be provided weekly once in physical mode. And they asked to do practices at home once daily. Adherence will be assessed through phone calls to the participants and a compliance register/diary.
Time of Yoga: Time of yoga will be in the morning while day shift work and evening (4 hours after eating) for night shift work.
Detail of the contents of Yoga Protocol
1. Shavasana 2-5 min ad, Pathya/Apathya:no, Pathya:, Apathya: | | 2 | Intervention Arm | Lifestyle | - | - | Dinacarya: , Ritucarya: , Acara Rasayana:, Other:AYURVEDA MODULE: Participants enrolled in the Group B will be intervened through Yoga Module for that training will be provided weekly once in physical mode. And they asked to do practices at home once daily. Adherence will be assessed through phone calls to the participants and compliance register/dairy. Beside this as a part of Ayurveda Module following intervention will be given to the participants: -
Procedures
• Pratimarsha Nasya with Tila Taila: 2 drops each nostril one time daily in m, Pathya/Apathya:no, Pathya:, Apathya: |
|
|
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Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1.Age between 30-45 years of age irrespective of work profile and gender.
2.Individuals having night shift work for more than 07 days per month.
3.Having this shift duty profession since longer than 6 months of duration.
4. Having PSQI score more than or equal to 5.
5.Participants fit to do yoga as decided by the principal investigator.
|
|
| ExclusionCriteria |
| Details |
1.Having any serious neurological and other pathological chronic disorder.
2.Having condition of pregnancy, lactation.
3.Having permanent night or day duty since more than one month
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. To evaluate the difference in levels of anti-inflammatory marker IL-10 after intervening the Ayurveda module along with Yoga module for lifestyle of night shift workers after 90 days. |
1. To evaluate the difference in levels of anti-inflammatory marker IL-10 after intervening the Ayurveda module along with Yoga module for lifestyle of night shift workers after 90 days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To evaluate the changes in PSQI score of night shift workers after 90 days of intervention.
2. To evaluate the changes in QOL-WHO Bref. Score of night shift workers after 90 days of intervention.
|
1. To evaluate the changes in PSQI score of night shift workers after 90 days of intervention.
2. To evaluate the changes in QOL-WHO Bref. Score of night shift workers after 90 days of intervention.
|
|
|
Target Sample Size
|
Total Sample Size="188"
Sample Size from India="188"
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)
|
05/06/2023 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
no publication yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
Night shift work induces sleep deprivation
which, in turn, alters the daily levels of alertness and job performance, favoring
fatigue. Moreover, fatigue reduces performance and job satisfaction, favoring
absence due to sickness, absenteeism, turnover, and job attrition and often
induces use of psychotropic drugs. In a study by Jamal and Baba, rotating shift
nurses showed a lower degree of job satisfaction. Decreased job satisfaction is
strongly associated with increased job stress. According to past studies, pro-inflammatory
cytokines were found to be elevated in highly stressed individuals. However,
inflammation is body’s defense mechanism in response to illnesses, caused due
to pathogens. Therefore, interventions that aim to reduce
systemic inflammation may not only help in the management of chronic disorders,
but also in the prevention of these disorders in individuals having an
increased risk. In a past study it was proven that yoga
practices could increase anti-inflammatory cytokine in industrial workers.
Particularly, industrial workers, who are in direct contact with the
pollutants, are affected most due to ill effects of pollutants. Exposure to
these pollutants leads to a systemic inflammatory response which can be
measured in terms of pro-inflammatory and anti-inflammatory markers.
So, the measures are necessity of the hour that
can increase the anti-inflammatory cytokines and decrease the pro-inflammatory
cytokines. So in this present study we will access add on effect of Ayurveda
module on one of these marker namely anti-inflammatory cytokine IL-10. |