Sports AnemiaNCT02996786
Effects of Danggui Buxue Tang on Blood Biochemical Parameters in Male Recreational Runners
A study testing Danggui Buxue Tang in people with Sports Anemia and Inflammation, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial summary
The aim of this study is to examine the beneficial effects of Danggui Buxue Tang on blood biochemical parameters in male recreational runners. Read more about this study
- Who is it for?
- Ages 20 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sports Anemia, Inflammation, Oxidative Stress
- What is being tested?
- Danggui Buxue Tang
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteTaiwan
- Study dates
- Oct 2016to Jul 2017
- 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 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- The participants should have the experience finishing 10-km run but without the experience of attending a marathon run.
Who cannot join
- Participants suffering from anemia (Hb <13 g/dL), taking usual supplements, medication, alcohol or not feeling comfortable.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to examine the beneficial effects of Danggui Buxue Tang on blood biochemical parameters in male recreational runners.
Read the detailed description
- Male recreational runners would be recruited by community websites or email. After completely introducing the study, the participants would be requested to sign informed consent.
- The participants would perform maximal oxygen consumption test prior to the supplementation. The participants would be supplemented with either Danggui Buxue Tang or placebo for a week before performing the 13-km run. A total of 4 times blood collection (before supplementation, immediate after running, 1 day and 3 days after running) would be performed for evaluating the effect of Danggui Buxue Tang on blood biochemical parameters.
- Conditions
- Sports Anemia, Inflammation, Oxidative Stress, Iron Deficiency, Hemolysis, Fatigue
- Being tested
- Danggui Buxue Tang, Placebo
- Medical subject headings
- Inflammation, Iron Deficiencies, Hemolysis, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Danggui Buxue TangDietary supplement
Danggui Buxue Tang purchased from Kaiser Pharmaceutical
PlaceboOther
Consisting of corn starch and carboxymethyl cellulose
| Study group | Role | What they receive |
|---|---|---|
| Danggui Buxue Tang group | Experimental | Danggui Buxue Tang group receive orally supplementation of 7.5 g/day of Danggui Buxue Tang for 10 days Receives: Dietary Supplement: Danggui Buxue Tang |
| Placebo group | Placebo comparator | Placebo group receive orally supplementation of 7.5 g/day of placebo for 10 days Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hematological parameters
Complete blood counts and serum haptoglobin and erythropoietin
Measured: Through study completion, an average of 1 year
Iron status
Serum iron, ferritin, transferrin and hepcidin
Measured: Through study completion, an average of 1 year
Oxidative stress
Thiobarbituric acid reactive substances, superoxide dismutase, catalase, and glutathione peroxidase
Measured: Through study completion, an average of 1 year
Inflammatory response
High-sensitivity c-reactive protein, Tumor necrosis factor-alpha, and interleukin-6
Measured: Through study completion, an average of 1 year
Secondary outcomes (1)
Running time
The completion time for a 13-km run
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2016 (estimated)
- Study startOct 2016
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sports AnemiaStudies of the same condition, open and under way.
- More trials run by Kaohsiung Medical University Chung-Ho Memorial HospitalThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02996786
- Sponsor's protocol ID
- MOST 106-2410-H-037-007-MY3
- Status last verified
- Nov 2016
- First submitted
- 11 Dec 2016
- Last updated
- 20 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Danggui Buxue Tang on Blood Biochemical Parameters in Male Recreational Runners
- ClinicalTrials.gov ID
- NCT02996786
- Acronym / sponsor ID
- MOST 106-2410-H-037-007-MY3
- Conditions
- Sports Anemia, Inflammation, Oxidative Stress, Iron Deficiency, Hemolysis, Fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 19 Dec 2016 (estimated)
- 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 aim of this study is to examine the beneficial effects of Danggui Buxue Tang on blood biochemical parameters in male recreational runners.
Detailed description
- Male recreational runners would be recruited by community websites or email. After completely introducing the study, the participants would be requested to sign informed consent.
- The participants would perform maximal oxygen consumption test prior to the supplementation. The participants would be supplemented with either Danggui Buxue Tang or placebo for a week before performing the 13-km run. A total of 4 times blood collection (before supplementation, immediate after running, 1 day and 3 days after running) would be performed for evaluating the effect of Danggui Buxue Tang on blood biochemical parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Danggui Buxue Tang group | Experimental | Dietary Supplement: Danggui Buxue TangDanggui Buxue Tang group receive orally supplementation of 7.5 g/day of Danggui Buxue Tang for 10 days |
| Placebo group | Placebo comparator | Other: PlaceboPlacebo group receive orally supplementation of 7.5 g/day of placebo for 10 days |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- The participants should have the experience finishing 10-km run but without the experience of attending a marathon run.
Key exclusion criteria (1 listed)
- Participants suffering from anemia (Hb <13 g/dL), taking usual supplements, medication, alcohol or not feeling comfortable.
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 |
|---|---|---|
| Danggui Buxue TangDanggui Buxue Tang purchased from Kaiser Pharmaceutical | Dietary supplement | Danggui Buxue Tang group |
| PlaceboConsisting of corn starch and carboxymethyl cellulose | Other | Placebo group |
Primary outcome
Hematological parameters
Time frame: Through study completion, an average of 1 year
Complete blood counts and serum haptoglobin and erythropoietin
Iron status
Time frame: Through study completion, an average of 1 year
Serum iron, ferritin, transferrin and hepcidin
Oxidative stress
Time frame: Through study completion, an average of 1 year
Thiobarbituric acid reactive substances, superoxide dismutase, catalase, and glutathione peroxidase
Inflammatory response
Time frame: Through study completion, an average of 1 year
High-sensitivity c-reactive protein, Tumor necrosis factor-alpha, and interleukin-6
1 secondary outcome
Running time
Time frame: Through study completion, an average of 1 year
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 20 Apr 2018.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Danggui Buxue Tang in people with Sports Anemia and Inflammation, run by Kaohsiung Medical University Chung-Ho Memorial Hospital 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 1 inclusion and 1 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 20 Apr 2018. 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?
Hematological parameters (time frame: Through study completion, an average of 1 year). 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 20 Apr 2018.