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

NCT ID: NCT05724238

Last Updated: 2023-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-26

Study Completion Date

2023-03-31

Brief Summary

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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

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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.

Conditions

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Fatigue

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Traditional Herbal Supplements

Traditional Herbal Supplements (Kuan Sin Yin)

Group Type EXPERIMENTAL

Traditional Herbal Supplements (Kuan Sin Yin)

Intervention Type DIETARY_SUPPLEMENT

Astragalus-based Kuan Sin Yin

Placebo

Placebo starch powder with 10% Kuan Sin Yin

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo starch powder with 10% Kuan Sin Yin

Interventions

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Traditional Herbal Supplements (Kuan Sin Yin)

Astragalus-based Kuan Sin Yin

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo starch powder with 10% Kuan Sin Yin

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Yang Ming Chiao Tung University

OTHER

Sponsor Role lead

Responsible Party

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Hsin-Jen Chen

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hsin-Jen Chen, PhD

Role: PRINCIPAL_INVESTIGATOR

National Yang Ming Chiao Tung University

Locations

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National Yang-Ming University

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Mao-Yuan Chen, MS

Role: CONTACT

+886228267000 ext. 67974

Hsin-Jen Chen, PhD

Role: CONTACT

+886228267000 ext. 65376

Facility Contacts

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Mao-Yuan Chen

Role: primary

886228267974

Other Identifiers

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YM109050F

Identifier Type: -

Identifier Source: org_study_id

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