FatigueNCT05724238
The Effects of Traditional Herbal Dietary Supplements on General Fatigue and Negative Emotions of Graduate Students
A study testing Traditional Herbal Supplements (Kuan Sin Yin) in people with Fatigue, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Fatigue
- What is being tested?
- Traditional Herbal Supplements (Kuan Sin Yin)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteTaiwan
- Study dates
- 26 Aug 2020to 31 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Taking medications as:
- Antidepressants
- Anxiolytics
- CNS stimulants
- Immunosuppressants
- With underlying diseases as:
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- Diabetes mellitus
- Hematologic diseases
- Other major diseases as defined my MOHW of Taiwan
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Yang-Ming University
Taipei, 112
Mao-Yuan Chen, 886228267974, astragalusproject@gmail.com
About this study
Official title: 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
Read the 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.
- Conditions
- Fatigue
- Being tested
- Traditional Herbal Supplements (Kuan Sin Yin), Placebo
- Keywords
- Astragalus, Traditional Herb, Fatigue, Negative Emotions, Graduate Students, Young Researchers
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional Herbal Supplements (Kuan Sin Yin)Dietary supplement
Astragalus-based Kuan Sin Yin
PlaceboDietary supplement
Placebo starch powder with 10% Kuan Sin Yin
| Study group | Role | What they receive |
|---|---|---|
| Traditional Herbal Supplements | Experimental | Traditional Herbal Supplements (Kuan Sin Yin) Receives: Dietary Supplement: Traditional Herbal Supplements (Kuan Sin Yin) |
| Placebo | Placebo comparator | Placebo starch powder with 10% Kuan Sin Yin Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: At week one (baseline) and week five (four weeks after the intervention)
Secondary outcomes (5)
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).
Measured: 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).
Measured: 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).
Measured: At week one and week five
Sleep Variables (Efficiency, Length, Midsleep time)
Measured by sleep diary
Measured: 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).
Measured: Each week since week one until week seven
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start26 Aug 2020
- Primary completion31 Mar 2023 (estimated)
- Study completion31 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FatigueStudies of the same condition, open and under way.
- More trials run by National Yang Ming Chiao Tung UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hsin-Jen Chen, National Yang Ming Chiao Tung University
- Investigators
- Hsin-Jen Chen, PhD, Principal investigator, National Yang Ming Chiao Tung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05724238
- Sponsor's protocol ID
- YM109050F
- Status last verified
- Feb 2023
- First submitted
- 19 Jan 2023
- Last updated
- 13 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Traditional Herbal Dietary Supplements on General Fatigue and Negative Emotions of Graduate Students: A Randomized, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT05724238
- Acronym / sponsor ID
- YM109050F
- Conditions
- Fatigue
- Keywords
- Astragalus, Traditional Herb, Fatigue, Negative Emotions, Graduate Students, Young Researchers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Study start
- 26 Aug 2020 (actual)
- Primary completion
- 31 Mar 2023 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 13 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional Herbal Supplements | Experimental | Dietary Supplement: Traditional Herbal Supplements (Kuan Sin Yin)Traditional Herbal Supplements (Kuan Sin Yin) |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo starch powder with 10% Kuan Sin Yin |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (9 listed)
- Taking medications as:
- Antidepressants
- Anxiolytics
- CNS stimulants
- Immunosuppressants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Traditional Herbal Supplements (Kuan Sin Yin)Astragalus-based Kuan Sin Yin | Dietary supplement | Traditional Herbal Supplements |
| PlaceboPlacebo starch powder with 10% Kuan Sin Yin | Dietary supplement | Placebo |
Primary outcome
Change from Baseline Fatigue Level to Four Weeks
Time frame: 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).
5 secondary outcomes
Change from Baseline Sleep Quality to Four Weeks
Time frame: At week one and week five
Change from Baseline Negative Emotion Scores to Four Weeks
Time frame: At week one and week five
Change from Baseline Negative Emotion States to Four Weeks
Time frame: At week one and week five
Sleep Variables (Efficiency, Length, Midsleep time)
Time frame: Each day from week one through week five
Change from Baseline Fatigue At Each Week up to Six Weeks
Time frame: Each week since week one until week seven
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hsin-Jen Chen, PhD principal investigator
National Yang Ming Chiao Tung University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional Herbal Supplements (Kuan Sin Yin) in people with Fatigue, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mao-Yuan Chen, MS (+886228267000 ext. 67974, astragalusproject@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Fatigue Level to Four Weeks (time frame: At week one (baseline) and week five (four weeks after the intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2023.