Oxidative StressC3GNCT01230268
A Study to Evaluate Pharmacokinetics of C3G and to Estimate Antioxidative Markers After Repeated Administration of Mulberry Fruit Extract
A study testing Mulberry fruit extract in people with Oxidative Stress, run by Seoul St. Mary's Hospital at 1 site in South Korea.
Trial summary
This study is to evaluate pharmacokinetic-pharmacodynamic property of C3G after administration of Mulberry fruit extract to 12 healthy Korean volunteers. Plasma concentration of C3G and the antioxidative markers such as total antioxidative capacity and attack of free oxygen radical will be measured. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Oxidative Stress
- What is being tested?
- Mulberry fruit extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2010to Dec 2010
- Phase
- Interventional
- 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 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body weight >55 kg for male, >45 kg for female (within 80-120% of Ideal body weight)
- Give written informed consent and voluntarily decide participation
Who cannot join
- Acute or chronic disease symptom on screening
- Existing active and clinically significant disease involving more than one organ system
- Known allergy to Mulberry or other berries
- Positive drug or alcohol screening
- Smokers of 10 or more cigarettes per day
- Participation in a clinical trial during last 2 month prior to the start of the study
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
This study is to evaluate pharmacokinetic-pharmacodynamic property of C3G after administration of Mulberry fruit extract to 12 healthy Korean volunteers. Plasma concentration of C3G and the antioxidative markers such as total antioxidative capacity and attack of free oxygen radical will be measured.
Additional objective is to investigate the multiple dose (2 weeks) safety of daily 1000mg Mulberry fruit extract.
This study, as an exploratory trial, does not required statistical hypothesis.
- Conditions
- Oxidative Stress
- Being tested
- Mulberry fruit extract
- Keywords
- C3G, Oxidative stress, Antioxidant, Mulberry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mulberry fruit extractOther
1000 mg oral daily dose for 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Mulberry fruit extract | Experimental | Daily 1000 mg oral Mulberry fruit extract is given to each subject for 2 weeks from Day2 after measuring antioxidative marker without intervention on Day1. Receives: Other: Mulberry fruit extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax - Maximum Observed Concentration - C3G in Plasma
Measured: Blood samples collected over 6 hours
AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) - C3G in Plasma
Measured: Blood samples collected over 6 hours
Antioxidative markers
Measured: 2 weeks
Secondary outcomes (1)
Number of Participants with Adverse Events
Measured: for 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2010 (estimated)
- Study startNov 2010
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxidative StressStudies of the same condition, open and under way.
- 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 N/A
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul St. Mary's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Rural Development Administration, Korea
- Investigators
- Dong-Seok Yim, M.D., Ph.D., Principal investigator, Seoul St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01230268
- Sponsor's protocol ID
- CPT2010-05
- Acronym
- C3G
- Status last verified
- Oct 2010
- First submitted
- 27 Oct 2010
- Last updated
- 14 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate Pharmacokinetics of C3G and to Estimate Antioxidative Markers After Repeated Administration of Mulberry Fruit Extract
- ClinicalTrials.gov ID
- NCT01230268
- Acronym / sponsor ID
- C3G / CPT2010-05
- Conditions
- Oxidative Stress
- Keywords
- C3G, Oxidative stress, Antioxidant, Mulberry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Seoul St. Mary's HospitalUniversity, hospital or other
- Collaborators
- Rural Development Administration, Korea
- Study start
- Nov 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 29 Oct 2010 (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.
This study is to evaluate pharmacokinetic-pharmacodynamic property of C3G after administration of Mulberry fruit extract to 12 healthy Korean volunteers. Plasma concentration of C3G and the antioxidative markers such as total antioxidative capacity and attack of free oxygen radical will be measured.
Additional objective is to investigate the multiple dose (2 weeks) safety of daily 1000mg Mulberry fruit extract.
This study, as an exploratory trial, does not required statistical hypothesis.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mulberry fruit extract | Experimental | Other: Mulberry fruit extractDaily 1000 mg oral Mulberry fruit extract is given to each subject for 2 weeks from Day2 after measuring antioxidative marker without intervention on Day1. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Body weight >55 kg for male, >45 kg for female (within 80-120% of Ideal body weight)
- Give written informed consent and voluntarily decide participation
Key exclusion criteria (7 listed)
- Acute or chronic disease symptom on screening
- Existing active and clinically significant disease involving more than one organ system
- Known allergy to Mulberry or other berries
- Positive drug or alcohol screening
- Smokers of 10 or more cigarettes per day
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 |
|---|---|---|
| Mulberry fruit extract1000 mg oral daily dose for 2 weeks | Other | Mulberry fruit extract |
Primary outcome
Cmax - Maximum Observed Concentration - C3G in Plasma
Time frame: Blood samples collected over 6 hours
AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) - C3G in Plasma
Time frame: Blood samples collected over 6 hours
Antioxidative markers
Time frame: 2 weeks
1 secondary outcome
Number of Participants with Adverse Events
Time frame: for 4 weeks
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 14 Dec 2010.
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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.
Dong-Seok Yim, M.D., Ph.D. principal investigator
Seoul St. Mary's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mulberry fruit extract in people with Oxidative Stress, run by Seoul St. Mary's Hospital at 1 site in South Korea.
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 2 inclusion and 7 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 14 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Cmax - Maximum Observed Concentration - C3G in Plasma (time frame: Blood samples collected over 6 hours). The study lists 3 primary outcomes in all. 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 14 Dec 2010.