NCT02996786

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 11, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 19, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

April 20, 2018

Status Verified

November 1, 2016

Enrollment Period

9 months

First QC Date

December 11, 2016

Last Update Submit

April 18, 2018

Conditions

Sports AnemiaInflammationOxidative StressIron DeficiencyHemolysisFatigue

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (1)

  • Running time

    Through study completion, an average of 1 year

Study Arms (2)

Danggui Buxue Tang group

EXPERIMENTAL

Danggui Buxue Tang group receive orally supplementation of 7.5 g/day of Danggui Buxue Tang for 10 days

Dietary Supplement: Danggui Buxue Tang

Placebo group

PLACEBO COMPARATOR

Placebo group receive orally supplementation of 7.5 g/day of placebo for 10 days

Other: Placebo

Interventions

Danggui Buxue TangDIETARY_SUPPLEMENT

Danggui Buxue Tang purchased from Kaiser Pharmaceutical

Danggui Buxue Tang group
PlaceboOTHER

Consisting of corn starch and carboxymethyl cellulose

Placebo group

Eligibility Criteria

Age20 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Medical University

Kaohsiung City, 807, Taiwan

Location

MeSH Terms

Conditions

InflammationIron DeficienciesHemolysisFatigue

Interventions

danggui buxue decoction

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 11, 2016

First Posted

December 19, 2016

Study Start

October 1, 2016

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

April 20, 2018

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)