Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02182934
Recruitment Status : Completed
First Posted : July 8, 2014
Last Update Posted : July 8, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

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

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 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 Sports People: a Double-blind, Placebo Controlled Pilot Study
Study Start Date : November 1999
Actual Primary Completion Date : April 2000

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



Primary Outcome Measures :
  1. Baseline-adjusted half-time hemoglobin re-oxygenation [ Time Frame: day 84 ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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 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

Layout table for additonal information
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02182934    
Other Study ID Numbers: 1020.11
First Posted: July 8, 2014    Key Record Dates
Last Update Posted: July 8, 2014
Last Verified: July 2014