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Completed

NCT Number: NCT02182882

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

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

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Key information

Conditions

Healthy

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GINSANA

Drug

Placebo

Drug

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Efficacy of Ginsana in Improving Half -Time Hemoglobin Re-oxygenation in Recreational Sportspeople: a Double Blind, Placebo Controlled Pilot Study

Important dates

Study start
1999
Primary completion
1999
First posted
Jul 8, 2014
Registry last updated
Jul 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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