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

NCT02182882 | Completed Phase 2

• 1 other identifier: 1020.10
• Study Type: interventional
• Target: 29
• Locations: 0 countries
• Sites: N/A

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Change from baseline in half-time hemoglobin re-oxygenation by Near InfraRed Spectroscopy (NIRS) methodology

  Baseline, day 84 post first drug dispense

Secondary Outcomes (5)

• 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

Study Arms (2)

GINSANA

EXPERIMENTAL

Drug: GINSANA

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

GINSANA DRUG

GINSANA

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2014
• First Posted: July 8, 2014
• Study Start: March 1, 1999
• Primary Completion: October 1, 1999
• Last Updated: July 8, 2014

Record last verified: 2014-07