Efficacy of Ginsana in Improving Half-time Hemoglobin Re-oxygenation in Healthy People

Phase 2

Completed

• Conditions: Healthy
• Interventions: Drug: Placebo; Drug: GINSANA

• Registration Number: NCT02182882
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

Study to assess the efficacy of ginsana in improving half-time hemoglobin re-oxygenation in healthy, recreational sportspeople and to assess the safety of the product

Detailed Description

Not available

Study Timeline

• Study Start: 1999-03
• Primary Completion: 1999-10
• Status Verified: 2014-07
• Study First Submitted: 2014-07-04
• Study First Submitted QC: 2014-07-04
• Last Update Submitted: 2014-07-04
• Study First Posted: 2014-07-08
• Last Update Posted: 2014-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

• Male and female volunteers between 18 and 40 years old
• Females must test negative for pregnancy
• Recreational athletes according to the american college of sports medicine (ACSM) definition
• Familiar with the cycle ergometer exercise methodology
• Written inform consent according to good clinical practice (GCP) and local regulations

Exclusion Criteria

• Pre-treatment (less than 2 weeks prior to inclusion in this trial) and/or concomitant treatment with any drug that any drug that could have influence the trail methodology
• Alcohol and drug abuse (as defined in Diagnostic and Statistic Manual IV( DSM-IV)) per subject verbal report
• Smokers
• Known hypertension
• Known hypercholesterolemia (moderate/severe)
• Female volunteers taking oral or injectable contraceptives
• Female volunteers of child bearing potential not using adequate means of birth control, other than contraceptive pills [intrauterine devices (IUDs)]
• Pregnancy and/or lactation
• Liver and/or renal disease and/or vascular disease
• Relevant allergy or known hypersensitivity to the investigational drug or its excipients
• Participation in another clinical trial within the last 4 weeks and concurrent participation in another clinical trial

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
GINSANA	GINSANA	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in half-time hemoglobin re-oxygenation by Near InfraRed Spectroscopy (NIRS) methodology	Baseline, day 84 post first drug dispense

Secondary Outcome Measures

Name	Time	Method
Maximum endurance time	up to day 84 post first drug dispense
Change from baseline in half-time hemoglobin re-oxygenation by NIRS methodology	Baseline, day 21, 42 and 63 post first drug dispense
Change from baseline in glutathion superdismutase / glutathion superdismutase oxidised (GSA/GSSG)	Baseline, up to day 84 post first drug dispense
Change from baseline in respiratory threshold	Baseline, up to day 84 post first drug dispense
Change from baseline in thiobarbituric acid (TBARS)	Baseline, up to day 84 post first drug dispense