The Effects of Traditional Herbal Dietary Supplements on General Fatigue and Negative Emotions of Graduate Students

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effects of Traditional Herbal Dietary Supplements on General Fatigue and Negative Emotions of Graduate Students: A Randomized, Placebo-controlled Study

Conditions
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Fatigue

Intervention / Treatment
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* Dietary Supplement: Traditional Herbal Supplements (Kuan Sin Yin)
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Traditional Herbal Supplements<br>Traditional Herbal Supplements (Kuan Sin Yin) | Dietary Supplement: Traditional Herbal Supplements (Kuan Sin Yin)<br>* Astragalus-based Kuan Sin Yin<br>|
| Placebo Comparator: Placebo<br>Placebo starch powder with 10% Kuan Sin Yin | Dietary Supplement: Placebo<br>* Placebo starch powder with 10% Kuan Sin Yin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Sleep Quality to Four Weeks | 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). | At week one and week five | 
| Change from Baseline Negative Emotion Scores to Four Weeks | 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). | At week one and week five | 
| Change from Baseline Negative Emotion States to Four Weeks | 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). | At week one and week five | 
| Sleep Variables (Efficiency, Length, Midsleep time) | Measured by sleep diary | Each day from week one through week five | 
| Change from Baseline Fatigue At Each Week up to Six 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). | Each week since week one until week seven | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Astragalus, Traditional Herb, Fatigue, Negative Emotions, Graduate Students, Young Researchers