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

Fatigue Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05724238
• Other study ID #: YM109050F
• Status: Recruiting
• Phase: N/A
• Start date: August 26, 2020
• Est. completion date: March 31, 2023

Study information

• Verified date: February 2023
• Source: National Yang Ming University
• Contact: Mao-Yuan Chen, MS
• Phone: +886228267000
• Email: astragalusproject[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: March 31, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatigue

Intervention

Dietary Supplement:
• Traditional Herbal Supplements (Kuan Sin Yin)
Astragalus-based Kuan Sin Yin
• Placebo
Placebo starch powder with 10% Kuan Sin Yin

Locations

Country	Name	City	State
Taiwan	National Yang-Ming University	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Yang Ming University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Sleep Variables (Efficiency, Length, Midsleep time)	Measured by sleep diary	Each day from week one through week five
Secondary	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