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

Primary Purpose

Fatigue

Status

Recruiting

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

Traditional Herbal Supplements (Kuan Sin Yin)

Placebo

About this trial

This is an interventional treatment trial for Fatigue focused on measuring Astragalus, Traditional Herb, Fatigue, Negative Emotions, Graduate Students, Young Researchers

Eligibility Criteria

20 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

National Yang-Ming UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Traditional Herbal Supplements

Placebo

Arm Description

Traditional Herbal Supplements (Kuan Sin Yin)

Placebo starch powder with 10% Kuan Sin Yin

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).

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).

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).

Sleep Variables (Efficiency, Length, Midsleep time)

Measured by sleep diary

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).

Full Information

NCT ID

NCT05724238

First Posted

January 19, 2023

Last Updated

February 1, 2023

Sponsor

National Yang Ming University

1. Study Identification

Unique Protocol Identification Number

NCT05724238

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

August 26, 2020 (Actual)

Primary Completion Date

March 31, 2023 (Anticipated)

Study Completion Date

March 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

National Yang Ming University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fatigue

Keywords

Astragalus, Traditional Herb, Fatigue, Negative Emotions, Graduate Students, Young Researchers

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Traditional Herbal Supplements

Arm Type

Experimental

Arm Description

Traditional Herbal Supplements (Kuan Sin Yin)

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo starch powder with 10% Kuan Sin Yin

Intervention Type

Dietary Supplement

Intervention Name(s)

Traditional Herbal Supplements (Kuan Sin Yin)

Intervention Description

Astragalus-based Kuan Sin Yin

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Description

Placebo starch powder with 10% Kuan Sin Yin

Primary Outcome Measure Information:

Title

Change from Baseline Fatigue Level to Four Weeks

Description

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).

Time Frame

At week one (baseline) and week five (four weeks after the intervention)

Secondary Outcome Measure Information:

Title

Change from Baseline Sleep Quality to Four Weeks

Description

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).

Time Frame

At week one and week five

Title

Change from Baseline Negative Emotion Scores to Four Weeks

Description

Time Frame

At week one and week five

Title

Change from Baseline Negative Emotion States to Four Weeks

Description

Time Frame

At week one and week five

Title

Sleep Variables (Efficiency, Length, Midsleep time)

Description

Measured by sleep diary

Time Frame

Each day from week one through week five

Title

Change from Baseline Fatigue At Each Week up to Six Weeks

Description

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).

Time Frame

Each week since week one until week seven

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mao-Yuan Chen, MS

Phone

+886228267000

Ext

67974

astragalusproject@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Hsin-Jen Chen, PhD

Phone

+886228267000

Ext

65376

hsinjenchen@nycu.edu.tw

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hsin-Jen Chen, PhD

Organizational Affiliation

National Yang Ming University

Official's Role

Principal Investigator

Facility Information:

Facility Name

National Yang-Ming University

City

Taipei

ZIP/Postal Code

112

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mao-Yuan Chen

Phone

886228267974

astragalusproject@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

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

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