Effects of Danggui Buxue Tang on Blood Biochemical Parameters in Male Recreational Runners

Inflammation Clinical Trial

Official title:

Effects of Danggui Buxue Tang on Blood Biochemical Parameters in Male Recreational Runners

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02996786
• Other study ID #: MOST 106-2410-H-037-007-MY3
• Status: Completed
• Phase: N/A
• First received: December 11, 2016
• Last updated: April 18, 2018
• Start date: October 2016
• Est. completion date: July 2017

Study information

• Verified date: November 2016
• Source: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Description:

1. 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.

2. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 30 Years

Eligibility

Inclusion Criteria:

• The participants should have the experience finishing 10-km run but without the experience of attending a marathon run.

Exclusion Criteria:

• Participants suffering from anemia (Hb <13 g/dL), taking usual supplements, medication, alcohol or not feeling comfortable.

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Fatigue
• Hemolysis
• Inflammation
• Iron Deficiency
• Oxidative Stress
• Sports Anemia

Intervention

Dietary Supplement:
• Danggui Buxue Tang
Danggui Buxue Tang purchased from Kaiser Pharmaceutical

Other:
• Placebo
Consisting of corn starch and carboxymethyl cellulose

Locations

Country	Name	City	State
Taiwan	Kaohsiung Medical University	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hematological parameters	Complete blood counts and serum haptoglobin and erythropoietin	Through study completion, an average of 1 year
Primary	Iron status	Serum iron, ferritin, transferrin and hepcidin	Through study completion, an average of 1 year
Primary	Oxidative stress	Thiobarbituric acid reactive substances, superoxide dismutase, catalase, and glutathione peroxidase	Through study completion, an average of 1 year
Primary	Inflammatory response	High-sensitivity c-reactive protein, Tumor necrosis factor-alpha, and interleukin-6	Through study completion, an average of 1 year
Secondary	Running time	The completion time for a 13-km run	Through study completion, an average of 1 year