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

Boehringer Ingelheim

Status and phase

Completed

Phase 2

Conditions

Healthy

Treatments

Drug: GINSANA

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT02182882

1020.10

Details and patient eligibility

About

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

Enrollment

29 patients

Sex

All

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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