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

Study Overview
=================
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.

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

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

Intervention / Treatment
-----------------
* Dietary Supplement: Danggui Buxue Tang
* Other: Placebo


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 30 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Danggui Buxue Tang group<br>Danggui Buxue Tang group receive orally supplementation of 7.5 g/day of Danggui Buxue Tang for 10 days | Dietary Supplement: Danggui Buxue Tang<br>* Danggui Buxue Tang purchased from Kaiser Pharmaceutical<br>|
| Placebo Comparator: Placebo group<br>Placebo group receive orally supplementation of 7.5 g/day of placebo for 10 days | Other: Placebo<br>* Consisting of corn starch and carboxymethyl cellulose<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hematological parameters | Complete blood counts and serum haptoglobin and erythropoietin | Through study completion, an average of 1 year | 
| Iron status | Serum iron, ferritin, transferrin and hepcidin | Through study completion, an average of 1 year | 
| Oxidative stress | Thiobarbituric acid reactive substances, superoxide dismutase, catalase, and glutathione peroxidase | Through study completion, an average of 1 year | 
| Inflammatory response | High-sensitivity c-reactive protein, Tumor necrosis factor-alpha, and interleukin-6 | Through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Running time | The completion time for a 13-km run | Through study completion, an average of 1 year |