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

Study Overview
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Brief Summary
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To assess the efficacy of Ginsana in improving hemoglobin re-oxygenation in healthy, recreational sports people and to assess the safety of the product.

Official Title
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Efficacy of Ginsana in Improving Half-time Hemoglobin Re-oxygenation in Recreational Sports People: a Double-blind, Placebo Controlled Pilot Study

Conditions
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Healthy

Intervention / Treatment
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* Drug: Ginsana
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ginsana<br> | Drug: Ginsana<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline-adjusted half-time hemoglobin re-oxygenation |  | day 84 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline-adjusted half-time hemoglobin re-oxygenation |  | day 21, 42 and 63 | 
| maximum endurance time |  | day 21, day 42, day 63 and day 84 | 
| Change from baseline in respiratory threshold |  | Baseline, up to day 84 | 
| 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 |