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

Efficacy of Ginsana in Improving Half-time Hemoglobin Re-oxygenation in Recreational Sports People: a Double-blind, Placebo Controlled Pilot Study

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02182934

Enrollment

Registered

2014-07-08

Start date

1999-11-30

Completion date

Unknown

Last updated

2014-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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.

Interventions

DRUGGinsana

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 40 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Baseline-adjusted half-time hemoglobin re-oxygenation	day 84

Secondary

Measure	Time frame
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026