Anti-stress Effect of Theanine on Students During Long-term Pharmacy Practices
Measurement of Stress Symptom in Students During Long-term Pharmacy Practices and Evaluation of Anti-stress Effect of Theanine Consumption on Students
1 other identifier
interventional
20
1 country
1
Brief Summary
Long-term practices in a hospital setting and community pharmacy might induce chronic stress in students. Alterations of salivary amylase activity will be measured in students during pharmacy practices as a marker of stress. Theanine is reported to have anti-stress effect on experimental animals under chronic stress and on humans under short-term stress. The purpose of this study is to measure stress symptoms in students during long-term pharmacy practices and to evaluate the efficacy of theanine in suppressing chronic stress, by measuring the salivary amylase activity.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 10, 2011
CompletedFirst Posted
Study publicly available on registry
May 26, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedJuly 16, 2013
July 1, 2013
7 months
May 10, 2011
July 14, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Alterations in salivary amylase activity in students with pharmacy practices
10 days
Secondary Outcomes (4)
Numbers of students deteriorated physical condition
10 days
Incidence of days of coming late or leaving early
10 days
Alterations in sleeping hours from baseline
10 days
Alterations in the response to a stress questionnaire from baseline
10 days
Study Arms (1)
Theanine
EXPERIMENTALExperimental Comparator, theanine Taking 4 tablets of theanine two times daily for 16 days Placebo Comparator, sucrose Taking 4 tablets of sucrose two times daily for 16 days
Interventions
Eligibility Criteria
You may qualify if:
- Students of pharmaceutical sciences in the fifth grade, nonsmoker
- Obtained written informed consent from the student before participation
- Possible to take tablets for 16 days
- Possible to check salivary amylase activity two times daily for 10 days
You may not qualify if:
- Taking tranquilizer(s)
- Smoker
- Diagnosed as inadequate to participate in the study by a doctor
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Shizuoka
Shizuoka, Shizuoka, 422-8526, Japan
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Unno, Keiko
University of Shizuoka
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 10, 2011
First Posted
May 26, 2011
Study Start
May 1, 2011
Primary Completion
December 1, 2011
Study Completion
April 1, 2012
Last Updated
July 16, 2013
Record last verified: 2013-07