Efficacy of Ginsana in Improving Half-time Hemoglobin Re-oxygenation in Healthy Recreational Sports People
Phase 2
Completed
- Conditions
- Healthy
- Interventions
- Drug: PlaceboDrug: Ginsana
- Registration Number
- NCT02182934
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
To assess the efficacy of Ginsana in improving hemoglobin re-oxygenation in healthy, recreational sports people and to assess the safety of the product.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 26
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 and/or concomitant treatment with any drug that any drug that may influence the trial symptomatology
- Alcohol and drug abuse as stated in the clinical trial manual
- 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 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 before the date of inclusion or 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 Baseline-adjusted half-time hemoglobin re-oxygenation day 84
- Secondary Outcome Measures
Name Time Method Change from baseline in thiobarbituric acid (TBARS) Baseline, up to day 84 Change from baseline in glutathione superdismutase/glutathione superdismutase oxidised (GSG/GSSG) ratio Baseline, up to day 84 Change from baseline in respiratory threshold Baseline, up to day 84 Baseline-adjusted half-time hemoglobin re-oxygenation day 21, 42 and 63 maximum endurance time day 21, day 42, day 63 and day 84