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

Study Overview
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Brief Summary
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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

Official Title
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Efficacy of Ginsana in Improving Half -Time Hemoglobin Re-oxygenation in Recreational Sportspeople: 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 (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

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 |
| --- | --- | --- |
| Change from baseline in half-time hemoglobin re-oxygenation by Near InfraRed Spectroscopy (NIRS) methodology |  | Baseline, day 84 post first drug dispense | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in half-time hemoglobin re-oxygenation by NIRS methodology |  | Baseline, day 21, 42 and 63 post first drug dispense | 
| Maximum endurance time |  | up to day 84 post first drug dispense | 
| Change from baseline in respiratory threshold |  | Baseline, up to day 84 post first drug dispense | 
| Change from baseline in thiobarbituric acid (TBARS) |  | Baseline, up to day 84 post first drug dispense | 
| Change from baseline in glutathion superdismutase / glutathion superdismutase oxidised (GSA/GSSG) |  | Baseline, up to day 84 post first drug dispense |