Efficacy of Ginsana in Improving Half-time Hemoglobin Re-oxygenation in Healthy Recreational Sports People
Last updated on April 2022Recruitment
- Recruitment Status
- Completed
Inclusion Criteria
- Females must test negative for pregnancy
- Written inform consent according to good clinical practice (GCP) and local regulations
- Familiar with the cycle ergometer exercise methodology
- ...
- Females must test negative for pregnancy
- Written inform consent according to good clinical practice (GCP) and local regulations
- Familiar with the cycle ergometer exercise methodology
- Male and female volunteers between 18 and 40 years old
- Recreational athletes according to the american college of sports medicine (ACSM) definition
Exclusion Criteria
- Liver and/or renal and/or vascular disease
- Female volunteers taking oral or injectable contraceptives
- Known hypercholesterolemia (moderate/severe)
- ...
- Liver and/or renal and/or vascular disease
- Female volunteers taking oral or injectable contraceptives
- Known hypercholesterolemia (moderate/severe)
- Alcohol and drug abuse as stated in the clinical trial manual
- Known hypertension
- Participation in another clinical trial within the last 4 weeks before the date of inclusion or concurrent participation in another clinical trial
- Female volunteers of child bearing potential not using adequate means of birth control, other than contraceptive pills [intrauterine devices (IUDs)]
- Smokers
- Relevant allergy or known hypersensitivity to the investigational drug or its excipients
- Pregnancy and/or lactation
- Pre treatment and/or concomitant treatment with any drug that any drug that may influence the trial symptomatology
Summary
- Conditions
- Healthy
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double
- Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 40 years
- Gender
- Both males and females
Inclusion Criteria
- Females must test negative for pregnancy
- Written inform consent according to good clinical practice (GCP) and local regulations
- Familiar with the cycle ergometer exercise methodology
- ...
- Females must test negative for pregnancy
- Written inform consent according to good clinical practice (GCP) and local regulations
- Familiar with the cycle ergometer exercise methodology
- Male and female volunteers between 18 and 40 years old
- Recreational athletes according to the american college of sports medicine (ACSM) definition
Exclusion Criteria
- Liver and/or renal and/or vascular disease
- Female volunteers taking oral or injectable contraceptives
- Known hypercholesterolemia (moderate/severe)
- ...
- Liver and/or renal and/or vascular disease
- Female volunteers taking oral or injectable contraceptives
- Known hypercholesterolemia (moderate/severe)
- Alcohol and drug abuse as stated in the clinical trial manual
- Known hypertension
- Participation in another clinical trial within the last 4 weeks before the date of inclusion or concurrent participation in another clinical trial
- Female volunteers of child bearing potential not using adequate means of birth control, other than contraceptive pills [intrauterine devices (IUDs)]
- Smokers
- Relevant allergy or known hypersensitivity to the investigational drug or its excipients
- Pregnancy and/or lactation
- Pre treatment and/or concomitant treatment with any drug that any drug that may influence the trial symptomatology
Tracking Information
- NCT #
- NCT02182934
- Collaborators
- Not Provided
- Investigators
- Not Provided
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