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

Sponsor

National Yang Ming University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05724238

Collaborator

(none)

Enrollment

Location

Arms

31.1

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Fatigue	Dietary Supplement: Traditional Herbal Supplements (Kuan Sin Yin) Dietary Supplement: Placebo	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 26, 2020

Anticipated Primary Completion Date :

Mar 31, 2023

Anticipated Study Completion Date :

Mar 31, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 45 Years

Sexes Eligible for Study:

All

Accepts 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