| CTRI Number |
CTRI/2017/08/009217 [Registered on: 01/08/2017] Trial Registered Retrospectively |
| Last Modified On: |
31/07/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Ayurveda Advised Life Style Modification in Sleep Disorders in People Working in Night shift |
|
Scientific Title of Study
|
A Study to Evaluate the Effect of Sleep Wake Scheduling on Nidraviparyaya with Special Reference to Shift Work Sleep Disorder
SHIFT WORK SLEEP DISORDER
|
| Trial Acronym |
SWSD |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR JYOTHI T |
| Designation |
PG SCHOLAR |
| Affiliation |
PARUL INSTITUTE OF AYURVEDA |
| Address |
PG Scholar
Dept of Kriya Sharira
Parul Institute of Ayurved
Parul University, P.O.Limda,Tal.Waghodia-391760, Dist.Vadodara,Gujarat, India
Vadodara
GUJARAT
391760
India |
| Phone |
9448643787 |
| Fax |
02668260201 |
| Email |
ayurjyothi.n@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR JYOTHI T |
| Designation |
PG SCHOLAR |
| Affiliation |
PARUL INSTITUTE OF AYURVEDA |
| Address |
PG Scholar
Dept of Kriya Sharira
Parul Institute of Ayurved
Parul University, P.O.Limda,Tal.Waghodia-391760, Dist.Vadodara,Gujarat, India
Vadodara
GUJARAT
391760
India |
| Phone |
9448643787 |
| Fax |
02668260201 |
| Email |
ayurjyothi.n@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vaidehi Raole |
| Designation |
Professor and Head |
| Affiliation |
PARUL INSTITUTE OF AYURVEDA |
| Address |
Dept of Kriya Sharira
Parul Institute of Ayurved
Parul University, P.O.Limda,Tal.Waghodia-391760, Dist.Vadodara,Gujarat, India
Vadodara
GUJARAT
391760
India |
| Phone |
|
| Fax |
|
| Email |
vraole3@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DR JYOTHI T |
| Address |
PG Scholar
Dept of Kriya Sharira
Parul Institute of Ayurved
Parul University, P.O.Limda,Tal.Waghodia-391760, Dist.Vadodara,Gujarat, India
PARUL UNIVERSITY, VADODARA 391760 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Jyothi T |
Parul Institute of Ayurved |
OPD NO. 106, Parul Ayurved Hospital, Parul Institute of Ayurved, Parul University, Vadodara, Gujarat, India
and neighboring industrial estates
Vadodara
GUJARAT |
09448643787
-
ayurjyothi.n@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE ON HUMAN RESEARCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Shift Work Sleep Disorder; DSM IV 307.45, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
lifestyle modification |
to sleep half of the time of usual sleep before food intake. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Adult workers of age group 18-60 years with symptoms of SWSD like insomnia or excessive sleepiness irrespective of gender working in Night shifts. Working from 2-10 years. |
|
| ExclusionCriteria |
| Details |
Night shift workers suffering with any systemic illness and on drugs. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| PQSI, WHO QoL, Agnibala, dehabala and Satwabala |
2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| WHO QoL, Agnibala, dehabala and Satwabala |
2 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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
02/01/2017 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NONE YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The symptoms of insomnia and excessive somnolence in association with some degree of social, occupational, or other impairment are collectively known as Shift Work Sleep Disorder (SWSD)[i]. ICD 10 identifies the condition under Circadian rhythm Sleep Disorders G47.26[ii] whereas DSM IV classification identifies under 307.45[iii]. The symptoms may range from gastrointestinal disorders, metabolic disorders, immunity disorders, cardiovascular diseases, cancer, and reproductive issues to neurological issues[iv].Shift work related sleep disorders causes significant changes in individuals’ physical, occupational, cognitive, and social functioning, which also decreases their quality of life (QoL)[v],[vi]. Night shift workers with symptomatic SWSD fulfilling the eligibility criteria will be incidentally selected who are voluntarily willing to participate in the study. Their baseline data will be obtained using Socio-demographic characteristics, PQSI, WHO QoL, Agnibala, dehabala and Satwabala. The selected workers will be advised to follow following lifestyle modification; to sleep half of the time of usual sleep before food intake. The workers are advised to maintain a sleep log to confirm sleeping/sleep loss pattern for a fortnight. The final evaluation will be done after study duration of 2 weeks.
[i] Peter A. et al.adverse health effects of shift work and shift work sleep disorder.dialogue and diagnosis// march 2012 [ii]www.sleepassociation.org/sleep-disorders-icd-10-codes-names/?fdx_switcher=true# accessed on 9th January, 2016. [iii]Diagnostic and statistical manual of Mental disorders, 4th ed. DSM- IV-TR, American Psychiatric association, Washington DC, 2005, 629. [iv] Peter A. et al.adverse health effects of shift work and shift work sleep disorder.dialogue and diagnosis// march 2012 shifts. Rev Esc Enferm USP. 2010;44(2):280-6. DOI:10.1590/S0080-62342010000200006 [vi] The WHOQOL Group. The World Health Organization quality of life assessment (WHOQOL): development and general psychometric properties. Soc Sci Med. 1998;46(12):1569-85. DOI:10.1016/S0277-9536(98)00009-4
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