The Effects of Traditional Herbal Dietary Supplements on General Fatigue and Negative Emotions of Graduate Students
1 other identifier
interventional
24
1 country
1
Brief Summary
The goal of this randomized controlled trial is to determine the effect of traditional herbal supplements on general fatigue and negative emotions in generally healthy graduate students. The main questions it aims to answer are: • Whether the traditional herbal supplements can ameliorate fatigue and negative emotions of young adults
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 Aug 2020
Typical duration for not_applicable
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
August 26, 2020
CompletedFirst Submitted
Initial submission to the registry
January 19, 2023
CompletedFirst Posted
Study publicly available on registry
February 13, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2023
CompletedFebruary 13, 2023
February 1, 2023
2.6 years
January 19, 2023
February 1, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from Baseline Fatigue Level to Four Weeks
Measured by validated Chinese version of Chalder's Fatigue Scale, the score of which ranges from 0-33, with the higher representing a higher fatigue level (i.e. a worse outcome).
At week one (baseline) and week five (four weeks after the intervention)
Secondary Outcomes (5)
Change from Baseline Sleep Quality to Four Weeks
At week one and week five
Change from Baseline Negative Emotion Scores to Four Weeks
At week one and week five
Change from Baseline Negative Emotion States to Four Weeks
At week one and week five
Sleep Variables (Efficiency, Length, Midsleep time)
Each day from week one through week five
Change from Baseline Fatigue At Each Week up to Six Weeks
Each week since week one until week seven
Study Arms (2)
Traditional Herbal Supplements
EXPERIMENTALTraditional Herbal Supplements (Kuan Sin Yin)
Placebo
PLACEBO COMPARATORPlacebo starch powder with 10% Kuan Sin Yin
Interventions
Astragalus-based Kuan Sin Yin
Eligibility Criteria
You may qualify if:
- Scoring at least 4 points on the dichotomous Chalder's Fatigue Scale at baseline
- Working on at least one ongoing research project and expecting to continue working for at least one month
You may not qualify if:
- Taking medications as:
- Antidepressants
- Anxiolytics
- CNS stimulants
- Immunosuppressants
- With underlying diseases as:
- Diabetes mellitus
- Hematologic diseases
- Other major diseases as defined my MOHW of Taiwan
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Yang-Ming University
Taipei, 112, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hsin-Jen Chen, PhD
National Yang Ming Chiao Tung University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
January 19, 2023
First Posted
February 13, 2023
Study Start
August 26, 2020
Primary Completion
March 31, 2023
Study Completion
March 31, 2023
Last Updated
February 13, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will not share