HealthyPhase 2NCT02182882
Efficacy of Ginsana in Improving Half-time Hemoglobin Re-oxygenation in Healthy People
A Phase 2 study testing GINSANA in people with Healthy, run by Boehringer Ingelheim.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- GINSANA
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- No sites listed yet
- Study dates
- Mar 1999to Oct 1999
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Pre-treatment (less than 2 weeks prior to inclusion in this trial) and/or concomitant treatment with any drug that any drug that could have influence the trail methodology
- 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
Show all 11Show fewer
- 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
About this study
Official title: Efficacy of Ginsana in Improving Half -Time Hemoglobin Re-oxygenation in Recreational Sportspeople: a Double Blind, Placebo Controlled Pilot Study
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
- Being tested
- GINSANA, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GINSANADrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| GINSANA | Experimental | Not described Receives: Drug: GINSANA |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in half-time hemoglobin re-oxygenation by Near InfraRed Spectroscopy (NIRS) methodology
Measured: Baseline, day 84 post first drug dispense
Secondary outcomes (5)
Change from baseline in half-time hemoglobin re-oxygenation by NIRS methodology
Measured: Baseline, day 21, 42 and 63 post first drug dispense
Maximum endurance time
Measured: up to day 84 post first drug dispense
Change from baseline in respiratory threshold
Measured: Baseline, up to day 84 post first drug dispense
Change from baseline in thiobarbituric acid (TBARS)
Measured: Baseline, up to day 84 post first drug dispense
Change from baseline in glutathion superdismutase / glutathion superdismutase oxidised (GSA/GSSG)
Measured: Baseline, up to day 84 post first drug dispense
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2014 (estimated)
- Study startMar 1999
- Primary completionOct 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02182882
- Sponsor's protocol ID
- 1020.10
- Status last verified
- Jul 2014
- First submitted
- 4 Jul 2014
- Last updated
- 8 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Ginsana in Improving Half -Time Hemoglobin Re-oxygenation in Recreational Sportspeople: a Double Blind, Placebo Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT02182882
- Acronym / sponsor ID
- 1020.10
- Conditions
- Healthy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Mar 1999
- Primary completion
- Oct 1999 (actual)
- First posted
- 8 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GINSANA | Experimental | Drug: GINSANA |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- Pre-treatment (less than 2 weeks prior to inclusion in this trial) and/or concomitant treatment with any drug that any drug that could have influence the trail methodology
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GINSANA | Drug | GINSANA |
| Placebo | Drug | Placebo |
Primary outcome
Change from baseline in half-time hemoglobin re-oxygenation by Near InfraRed Spectroscopy (NIRS) methodology
Time frame: Baseline, day 84 post first drug dispense
5 secondary outcomes
Change from baseline in half-time hemoglobin re-oxygenation by NIRS methodology
Time frame: Baseline, day 21, 42 and 63 post first drug dispense
Maximum endurance time
Time frame: up to day 84 post first drug dispense
Change from baseline in respiratory threshold
Time frame: Baseline, up to day 84 post first drug dispense
Change from baseline in thiobarbituric acid (TBARS)
Time frame: Baseline, up to day 84 post first drug dispense
Change from baseline in glutathion superdismutase / glutathion superdismutase oxidised (GSA/GSSG)
Time frame: Baseline, up to day 84 post first drug dispense
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GINSANA in people with Healthy, run by Boehringer Ingelheim.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in half-time hemoglobin re-oxygenation by Near InfraRed Spectroscopy (NIRS) methodology (time frame: Baseline, day 84 post first drug dispense). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2014.