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

April 18, 2018 updated by: Kaohsiung Medical University Chung-Ho Memorial Hospital
The aim of this study is to examine the beneficial effects of Danggui Buxue Tang on blood biochemical parameters in male recreational runners.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan, 807
        • Kaohsiung Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 28 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hematological parameters
Time Frame: Through study completion, an average of 1 year
Complete blood counts and serum haptoglobin and erythropoietin
Through study completion, an average of 1 year
Iron status
Time Frame: Through study completion, an average of 1 year
Serum iron, ferritin, transferrin and hepcidin
Through study completion, an average of 1 year
Oxidative stress
Time Frame: Through study completion, an average of 1 year
Thiobarbituric acid reactive substances, superoxide dismutase, catalase, and glutathione peroxidase
Through study completion, an average of 1 year
Inflammatory response
Time Frame: Through study completion, an average of 1 year
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
Time Frame: Through study completion, an average of 1 year
The completion time for a 13-km run
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2016

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

July 1, 2017

Study Registration Dates

First Submitted

December 11, 2016

First Submitted That Met QC Criteria

December 14, 2016

First Posted (Estimate)

December 19, 2016

Study Record Updates

Last Update Posted (Actual)

April 20, 2018

Last Update Submitted That Met QC Criteria

April 18, 2018

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MOST 106-2410-H-037-007-MY3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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