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

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

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

Study Overview

• Status: Recruiting
• Conditions: Fatigue
• Intervention / Treatment: Dietary supplement: Traditional Herbal Supplements (Kuan Sin Yin); Dietary supplement: Placebo

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.

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mao-Yuan Chen, MS; Phone Number: 67974 +886228267000; Email: astragalusproject@gmail.com
• Study Contact Backup: Name: Hsin-Jen Chen, PhD; Phone Number: 65376 +886228267000; Email: hsinjenchen@nycu.edu.tw

Study Locations

• Taiwan
  • Taipei, Taiwan, 112
    • Recruiting
    • National Yang-Ming University
    • Contact: Mao-Yuan Chen; Phone Number: 886228267974; Email: astragalusproject@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Traditional Herbal Supplements; Traditional Herbal Supplements (Kuan Sin Yin)	Dietary supplement: Traditional Herbal Supplements (Kuan Sin Yin); Astragalus-based Kuan Sin Yin
PLACEBO_COMPARATOR: Placebo; Placebo starch powder with 10% Kuan Sin Yin	Dietary supplement: Placebo; Placebo starch powder with 10% Kuan Sin Yin

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: National Yang Ming University

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 26, 2020
• Primary Completion (ANTICIPATED): March 31, 2023
• Study Completion (ANTICIPATED): March 31, 2023

Study Registration Dates

• First Submitted: January 19, 2023
• First Submitted That Met QC Criteria: February 1, 2023
• First Posted (ACTUAL): February 13, 2023

Study Record Updates

• Last Update Posted (ACTUAL): February 13, 2023
• Last Update Submitted That Met QC Criteria: February 1, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Fatigue; Astragalus; Traditional Herb; Negative Emotions; Graduate Students; Young Researchers
• Additional Relevant MeSH Terms: Fatigue
• Other Study ID Numbers: YM109050F

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No