FatigueNCT05877677
The Effects Assessment of the Polygonatum Kingianum Extract on Endurance Performance and Anti-fatigue
A study testing Polygonatum kingianum extract drink in people with Fatigue, run by TCI Co., Ltd. at 1 site in Taiwan.
Trial summary
To assess the efficacy of polygonatum kingianum extract on endurance performance and anti-fatigue Read more about this study
- Who is it for?
- Ages 30 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Fatigue
- What is being tested?
- Polygonatum kingianum extract drink
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- 18 May 2023to 1 Jul 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 30 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male aged 30-60 years old
- Must read and sign the informed consent form
- During the experiment, do not change the lifestyle and eating habits
- Cooperate not to engage in high-intensity exercise 48 hours before each experiment
Who cannot join
- Subject who is not willing to participate in this study.
- People with serious diseases of heart, liver, kidney, endocrine and other organs (such as hypertension, diabetes, renal dysfunction and heart-related diseases) and mental patients
- People who have undergone surgery within 6 months or have lower limb injuries
- People who are allergic to Polygonatum kingianum extract
- Participate in other clinical trials related to anti-fatigue within four weeks of the trial
- Students who are currently taking courses taught by the principal investigator of this trial.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
National Pingtung University of Science and Technology
Pingtung City
About this study
To assess the efficacy of polygonatum kingianum extract on endurance performance and anti-fatigue
- Conditions
- Fatigue
- Being tested
- Placebo drink, Polygonatum kingianum extract drink
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo drinkDietary supplement
consume 1 bottle per day
Polygonatum kingianum extract drinkDietary supplement
Also called Dragon Power® Polygonatum kingianum extract drink
consume 1 bottle per day
| Study group | Role | What they receive |
|---|---|---|
| Placebo drink | Placebo comparator | consume 1 bottle per day Receives: Dietary Supplement: Placebo drink |
| Polygonatum kingianum extract drink | Experimental | consume 1 bottle per day Receives: Dietary Supplement: Polygonatum kingianum extract drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of aerobic endurance
3-min step test is used to assess aerobic endurance
Measured: Day 0, day 14, day28
The change of continuous attention performance
Canon continuous attention software (Conners' Continuous Performance Test) is used to assess continuous attention performance
Measured: Day 0, day 14, day28
The change of concentration of testosterone in blood
Fasting venous blood was sampled to measure concentrations of testosterone
Measured: Day 0, day 14, day28
The change of blood PDE5 gene expression
Fasting venous blood was sampled to measure the expression of PDE5 gene
Measured: Day 0, day 14, day28
Secondary outcomes (2)
The change of blood nitric oxide (NO)
Fasting venous blood was sampled to measure concentrations of nitric oxide
Measured: Day 0, day 14, day28
The change of self-assessment fatigue condition
A 10 point likert scale was utilized to evaluate fatigue condition. The higher the score, the higher the fatigue level.
Measured: Day 0, day 14, day28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2023
- Study start18 May 2023
- Primary completion17 Jun 2023
- Study completion1 Jul 2023
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.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- TCI Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bo-han Wu, Principal investigator, National Pingtung University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05877677
- Sponsor's protocol ID
- 23-027-A
- Status last verified
- Aug 2023
- First submitted
- 17 May 2023
- Last updated
- 8 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects Assessment of the Polygonatum Kingianum Extract on Endurance Performance and Anti-fatigue
- ClinicalTrials.gov ID
- NCT05877677
- Acronym / sponsor ID
- 23-027-A
- Conditions
- Fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- TCI Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 18 May 2023 (actual)
- Primary completion
- 17 Jun 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 26 May 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.
To assess the efficacy of polygonatum kingianum extract on endurance performance and anti-fatigue
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo drink | Placebo comparator | Dietary Supplement: Placebo drinkconsume 1 bottle per day |
| Polygonatum kingianum extract drink | Experimental | Dietary Supplement: Polygonatum kingianum extract drinkconsume 1 bottle per day |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male aged 30-60 years old
- Must read and sign the informed consent form
- During the experiment, do not change the lifestyle and eating habits
- Cooperate not to engage in high-intensity exercise 48 hours before each experiment
Key exclusion criteria (6 listed)
- Subject who is not willing to participate in this study.
- People with serious diseases of heart, liver, kidney, endocrine and other organs (such as hypertension, diabetes, renal dysfunction and heart-related diseases) and mental patients
- People who have undergone surgery within 6 months or have lower limb injuries
- People who are allergic to Polygonatum kingianum extract
- Participate in other clinical trials related to anti-fatigue within four weeks of the trial
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 |
|---|---|---|
| Placebo drinkconsume 1 bottle per day | Dietary supplement | Placebo drink |
| Polygonatum kingianum extract drinkAlso: Dragon Power® Polygonatum kingianum extract drinkconsume 1 bottle per day | Dietary supplement | Polygonatum kingianum extract drink |
Primary outcome
The change of aerobic endurance
Time frame: Day 0, day 14, day28
3-min step test is used to assess aerobic endurance
The change of continuous attention performance
Time frame: Day 0, day 14, day28
Canon continuous attention software (Conners' Continuous Performance Test) is used to assess continuous attention performance
The change of concentration of testosterone in blood
Time frame: Day 0, day 14, day28
Fasting venous blood was sampled to measure concentrations of testosterone
The change of blood PDE5 gene expression
Time frame: Day 0, day 14, day28
Fasting venous blood was sampled to measure the expression of PDE5 gene
2 secondary outcomes
The change of blood nitric oxide (NO)
Time frame: Day 0, day 14, day28
The change of self-assessment fatigue condition
Time frame: Day 0, day 14, day28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2023.
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Comparison of Functional Inspiratory Muscle Training and Combined Exercise Training in Individuals With Type 2 Diabetes
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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.
Bo-han Wu principal investigator
National Pingtung University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polygonatum kingianum extract drink in people with Fatigue, run by TCI Co., Ltd. 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 4 inclusion and 6 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: finished, as of the sponsor's last update on 8 Aug 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of aerobic endurance (time frame: Day 0, day 14, day28). The study lists 4 primary outcomes in all. 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 8 Aug 2023.