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Completed

NCT Number: NCT02182934

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

To assess the efficacy of Ginsana in improving hemoglobin re-oxygenation in healthy, recreational sports people 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 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

Treatment and study plan

GINSANA

Drug

Placebo

Drug

Primary outcomes

  1. Baseline-adjusted half-time hemoglobin re-oxygenation

    Time frame: day 84

Secondary outcomes

  1. Baseline-adjusted half-time hemoglobin re-oxygenation

    Time frame: day 21, 42 and 63

  2. maximum endurance time

    Time frame: day 21, day 42, day 63 and day 84

  3. Change from baseline in respiratory threshold

    Time frame: Baseline, up to day 84

  4. Change from baseline in thiobarbituric acid (TBARS)

    Time frame: Baseline, up to day 84

  5. Change from baseline in glutathione superdismutase/glutathione superdismutase oxidised (GSG/GSSG) ratio

    Time frame: Baseline, up to day 84

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 Sports People: a Double-blind, Placebo Controlled Pilot Study

Important dates

Study start
1999
Primary completion
2000
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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