Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Participants will:
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Traditional Herbal Supplements | Experimental | Traditional Herbal Supplements (Kuan Sin Yin) |
|
| Placebo | Placebo Comparator | Placebo starch powder with 10% Kuan Sin Yin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Traditional Herbal Supplements (Kuan Sin Yin) | Dietary Supplement | Astragalus-based Kuan Sin Yin |
|
| 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) |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mao-Yuan Chen, MS | Contact | +886228267000 | 67974 | astragalusproject@gmail.com |
| Hsin-Jen Chen, PhD | Contact | +886228267000 | 65376 | hsinjenchen@nycu.edu.tw |
| Name | Affiliation | Role |
|---|---|---|
| Hsin-Jen Chen, PhD | National Yang Ming Chiao Tung University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Yang-Ming University | Recruiting | Taipei | 112 | Taiwan |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Dietary Supplement | Placebo starch powder with 10% Kuan Sin Yin |
|
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 |