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

NCT02182934 | Completed Phase 2

• 1 other identifier: 1020.11
• Study Type: interventional
• Target: 26
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Baseline-adjusted half-time hemoglobin re-oxygenation

  day 84

Secondary Outcomes (5)

• Baseline-adjusted half-time hemoglobin re-oxygenation

  day 21, 42 and 63

• maximum endurance time

  day 21, day 42, day 63 and day 84

• Change from baseline in respiratory threshold

  Baseline, up to day 84

• Change from baseline in thiobarbituric acid (TBARS)

  Baseline, up to day 84

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

  Baseline, up to day 84

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:

• 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

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: November 1, 1999
• Primary Completion: April 1, 2000
• Last Updated: July 8, 2014

Record last verified: 2014-07