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

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ClinicalTrials.gov Identifier: NCT02182882
Recruitment Status : Completed
First Posted : July 8, 2014
Last Update Posted : July 8, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

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

Condition or disease Intervention/treatment Phase
Healthy Drug: GINSANA Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Efficacy of Ginsana in Improving Half -Time Hemoglobin Re-oxygenation in Recreational Sportspeople: a Double Blind, Placebo Controlled Pilot Study
Study Start Date : March 1999
Actual Primary Completion Date : October 1999

Arm Intervention/treatment
Experimental: GINSANA Drug: GINSANA
Placebo Comparator: Placebo Drug: Placebo



Primary Outcome Measures :
  1. Change from baseline in half-time hemoglobin re-oxygenation by Near InfraRed Spectroscopy (NIRS) methodology [ Time Frame: Baseline, day 84 post first drug dispense ]

Secondary Outcome Measures :
  1. Change from baseline in half-time hemoglobin re-oxygenation by NIRS methodology [ Time Frame: Baseline, day 21, 42 and 63 post first drug dispense ]
  2. Maximum endurance time [ Time Frame: up to day 84 post first drug dispense ]
  3. Change from baseline in respiratory threshold [ Time Frame: Baseline, up to day 84 post first drug dispense ]
  4. Change from baseline in thiobarbituric acid (TBARS) [ Time Frame: Baseline, up to day 84 post first drug dispense ]
  5. Change from baseline in glutathion superdismutase / glutathion superdismutase oxidised (GSA/GSSG) [ Time Frame: Baseline, up to day 84 post first drug dispense ]


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02182882    
Other Study ID Numbers: 1020.10
First Posted: July 8, 2014    Key Record Dates
Last Update Posted: July 8, 2014
Last Verified: July 2014