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

NCT ID: NCT02182882

Last Updated: 2014-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-03-31

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

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

GINSANA

Group Type: EXPERIMENTAL

GINSANA

Intervention Type: DRUG

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

GINSANA

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

1020.10

Identifier Type: -

Identifier Source: org_study_id