Back to resultsEffects of Danggui Buxue Tang on Blood Biochemical Parameters in Male Recreational Runners
Primary Purpose
Sports Anemia, Inflammation, Oxidative Stress
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Danggui Buxue Tang
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Sports Anemia
Eligibility Criteria
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.
Sites / Locations
- Kaohsiung Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Danggui Buxue Tang group
Placebo group
Arm Description
Danggui Buxue Tang group receive orally supplementation of 7.5 g/day of Danggui Buxue Tang for 10 days
Placebo group receive orally supplementation of 7.5 g/day of placebo for 10 days
Outcomes
Primary Outcome Measures
Hematological parameters
Complete blood counts and serum haptoglobin and erythropoietin
Iron status
Serum iron, ferritin, transferrin and hepcidin
Oxidative stress
Thiobarbituric acid reactive substances, superoxide dismutase, catalase, and glutathione peroxidase
Inflammatory response
High-sensitivity c-reactive protein, Tumor necrosis factor-alpha, and interleukin-6
Secondary Outcome Measures
Running time
The completion time for a 13-km run
Full Information
NCT ID
NCT02996786
First Posted
December 11, 2016
Last Updated
April 18, 2018
Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02996786
Brief Title
Effects of Danggui Buxue Tang on Blood Biochemical Parameters in Male Recreational Runners
Official Title
Effects of Danggui Buxue Tang on Blood Biochemical Parameters in Male Recreational Runners
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
October 2016 (Actual)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
July 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sports Anemia, Inflammation, Oxidative Stress, Iron Deficiency, Hemolysis, Fatigue
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Danggui Buxue Tang group
Arm Type
Experimental
Arm Description
Danggui Buxue Tang group receive orally supplementation of 7.5 g/day of Danggui Buxue Tang for 10 days
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Placebo group receive orally supplementation of 7.5 g/day of placebo for 10 days
Intervention Type
Dietary Supplement
Intervention Name(s)
Danggui Buxue Tang
Intervention Description
Danggui Buxue Tang purchased from Kaiser Pharmaceutical
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Consisting of corn starch and carboxymethyl cellulose
Primary Outcome Measure Information:
Title
Hematological parameters
Description
Complete blood counts and serum haptoglobin and erythropoietin
Time Frame
Through study completion, an average of 1 year
Title
Iron status
Description
Serum iron, ferritin, transferrin and hepcidin
Time Frame
Through study completion, an average of 1 year
Title
Oxidative stress
Description
Thiobarbituric acid reactive substances, superoxide dismutase, catalase, and glutathione peroxidase
Time Frame
Through study completion, an average of 1 year
Title
Inflammatory response
Description
High-sensitivity c-reactive protein, Tumor necrosis factor-alpha, and interleukin-6
Time Frame
Through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Running time
Description
The completion time for a 13-km run
Time Frame
Through study completion, an average of 1 year
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Kaohsiung Medical University
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Danggui Buxue Tang on Blood Biochemical Parameters in Male Recreational Runners
We'll reach out to this number within 24 hrs