Fatigue
Conditions
Keywords
Astragalus, Traditional Herb, Fatigue, Negative Emotions, Graduate Students, Young Researchers
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
Detailed description
Participants will: * Take oral herbal supplements or placebo as randomized for four weeks * Be evaluated for the fatigue, anxiety, and depression levels at baseline and four weeks after the intervention * Record sleep variables each day for five weeks Researchers will compare the intervention group (receiving herbal supplements) with the placebo group (receiving placebo) to see if oral herbal supplements have effects on the outcomes and to examine the anti-fatigue effect two weeks after intervention.
Interventions
DIETARY_SUPPLEMENTTraditional Herbal Supplements (Kuan Sin Yin)
Astragalus-based Kuan Sin Yin
DIETARY_SUPPLEMENTPlacebo
Placebo starch powder with 10% Kuan Sin Yin
Sponsors
National Yang Ming Chiao Tung University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline Fatigue Level to Four Weeks | At week one (baseline) and week five (four weeks after the intervention) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline Sleep Quality to Four Weeks | At week one and week five | Measured by the Chinese version of PSQI (Pittsburgh Sleep Quality Index), the score of which ranges from 0-21, with the higher representing a worse sleep quality (i.e. a worse outcome). |
| Change from Baseline Negative Emotion Scores to Four Weeks | At week one and week five | Measured by the Chinese version of DASS-21 (Depression, Anxiety and Stress Scale-21 Items), the score of which ranges from 0-63, with the higher scores representing a higher negative emotion level (i.e. a worse outcome). |
| Change from Baseline Negative Emotion States to Four Weeks | At week one and week five | Measured by the Chinese version of STAI-Y (State Trait Anxiety Inventory-Form Y), the score of which ranges from 20-80, with the higher representing a higher negative emotion level (i.e. a worse outcome). |
| Sleep Variables (Efficiency, Length, Midsleep time) | Each day from week one through week five | Measured by sleep diary |
| Change from Baseline Fatigue At Each Week up to Six Weeks | Each week since week one until week seven | 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). |
Countries
Taiwan
Contacts
Primary ContactMao-Yuan Chen, MS
Backup ContactHsin-Jen Chen, PhD
Outcome results
None listed