Eye DiseaseNCT02321189
The Effect of Resveratrol Based Nutritional Supplement on Choroidal Thickness
A study testing LONGEVINEX in people with Eye Disease, run by Huazhong University of Science and Technology at 1 site in China.
Trial summary
Choroidal thickness represents blood-flowing of eyes. The investigators detect the choroidal thickness of the young participant using SD-OCT to see the effect of Resveratrol Based Nutritional Supplement on Choroidal Thickness. Read more about this study
- Who is it for?
- Ages 23 to 28 yearsHealthy volunteers can take part
- Conditions the study is for
- Eye Disease
- What is being tested?
- LONGEVINEX
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteChina
- Study dates
- Oct 2014to May 2015
- 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 23 to 28 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male and female patients 23-28 years of age. nonsmokers.
- Patients were considered to be healthy on the basis of electrocardiogram (ECG), and clinical laboratory safety tests (haematology, plasma biochemistry, urinalysis and hepatitis B, hepatitis C and HIV serology) performed at screening.
- Avoid ingesting grapefruit, grapefruit juice or other grapefruit juice containing products, and any herbal-based nutrient supplement or prescribed medications( grapefruit, cranberry, blueberry products, peanuts and peanut butter, grape and grape products, and red wine ) during the same period of time.
- patients should abstain from alcohol-containing beverages at least two days prior to and during the study.
Who cannot join
- Uncontrolled Blood pressure exceeding diastolic pressure of 100 mm Hg (sitting) during the screening period and uncontrolled diabetes mellitus
- Participation in another simultaneous medical investigation or trial Renal failure requiring dialysis or renal transplant or liver dysfunction History of other disease,or other findings giving reasonable suspicion of a disease or condition that contraindicates the use an investigational drug, might affect interpretation of the results of the study, or render the subject at high risk from treatment complications.
- IOP over 30 mmHg.
- Any previous retinal laser photocoagulation to the study eye in treatment naive. Any previous intravitreal injection in study eye (triamcinolone or other) in treatment naive.
- Any previous vitrectomy in study eye (posterior or anterior associated with vitreous loss in cataract surgery).
- Intracapsular cataract extraction (posterior capsule needs to be present).
- Aphakia or absence of the posterior capsule in the study eye, Structural damage to the center of the macula in the study eye preexisting to CRVO likely to preclude improvement in visual acuity following the resolution of macular edema, including atrophy of the retinal pigment epithelium, subretinal fibrosis, laser scar(s).
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tongji Medical College of HUST
Wuhan, Hubei
Shuaishuai Wang, 15623422892, 949990624@qq.com
About this study
Choroidal thickness represents blood-flowing of eyes. The investigators detect the choroidal thickness of the young participant using SD-OCT to see the effect of Resveratrol Based Nutritional Supplement on Choroidal Thickness.
Read the detailed description
34 young, healthy participants were included in this study; They were randomly divided into two groups by age and gender matched.100 mg Longevinex® capsule was given to the study group and 100mg placebo capsule to the control group. All participants underwent OCT scanning with spectral domain optic coherence tomography (SD-OCT) at baseline and 1 h following Longevinex® or placebo administration. The choroidal thickness was measured manually by the Heidelberg Eye explore software(version 5.3.3.0, Heidelberg Engineering) with a vertical line to the retinal pigment epithelial layer.
- Conditions
- Eye Disease
- Being tested
- LONGEVINEX, placebo
- Medical subject headings
- Eye Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LONGEVINEXDrug
let everyone of the participants oral 1 capsule containing 100 mg LONGEVINEX
placeboDrug
let everyone of the participants oral 1 capsule containing 100 mg placebo
| Study group | Role | What they receive |
|---|---|---|
| LONGEVINEX | Placebo comparator | The Effect of LONGEVINEX on Choroidal Thickness Receives: Drug: LONGEVINEX |
| placebo | Placebo comparator | The Effect of placebo on Choroidal Thickness Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Choroidal Thickness(micrometer)
using Heidelberg Eye Explorer software to measure choroidal thickness of participants
Measured: baseline
Secondary outcomes (1)
Choroidal Thickness(micrometer)
using Heidelberg Eye Explorer software to measure choroidal thickness of participants
Measured: 1 hour after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2014 (estimated)
- Study startOct 2014
- Primary completionMay 2015 (estimated)
- Study completionMay 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eye DiseaseStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe 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 N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xufang Sun, Huazhong University of Science and Technology
- Investigators
- Xunfang Sun, Study director, Department of Ophthalmology,Tongji Hospital, Tongji Medical College, Huazhong University of science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02321189
- Sponsor's protocol ID
- Sun3
- Status last verified
- Apr 2015
- First submitted
- 8 Nov 2014
- Last updated
- 3 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Resveratrol Based Nutritional Supplement on Choroidal Thickness
- ClinicalTrials.gov ID
- NCT02321189
- Acronym / sponsor ID
- Sun3
- Conditions
- Eye Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- May 2015 (estimated)
- Study completion
- May 2015 (estimated)
- First posted
- 22 Dec 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.
Choroidal thickness represents blood-flowing of eyes. The investigators detect the choroidal thickness of the young participant using SD-OCT to see the effect of Resveratrol Based Nutritional Supplement on Choroidal Thickness.
Detailed description
34 young, healthy participants were included in this study; They were randomly divided into two groups by age and gender matched.100 mg Longevinex® capsule was given to the study group and 100mg placebo capsule to the control group. All participants underwent OCT scanning with spectral domain optic coherence tomography (SD-OCT) at baseline and 1 h following Longevinex® or placebo administration. The choroidal thickness was measured manually by the Heidelberg Eye explore software(version 5.3.3.0, Heidelberg Engineering) with a vertical line to the retinal pigment epithelial layer.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LONGEVINEX | Placebo comparator | Drug: LONGEVINEXThe Effect of LONGEVINEX on Choroidal Thickness |
| placebo | Placebo comparator | Drug: placeboThe Effect of placebo on Choroidal Thickness |
Who may qualify
- Ages
- 23 to 28 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male and female patients 23-28 years of age. nonsmokers.
- Patients were considered to be healthy on the basis of electrocardiogram (ECG), and clinical laboratory safety tests (haematology, plasma biochemistry, urinalysis and hepatitis B, hepatitis C and HIV serology) performed at screening.
- Avoid ingesting grapefruit, grapefruit juice or other grapefruit juice containing products, and any herbal-based nutrient supplement or prescribed medications( grapefruit, cranberry, blueberry products, peanuts and peanut butter, grape and grape products, and red wine ) during the same period of time.
- patients should abstain from alcohol-containing beverages at least two days prior to and during the study.
Key exclusion criteria (7 listed)
- Uncontrolled Blood pressure exceeding diastolic pressure of 100 mm Hg (sitting) during the screening period and uncontrolled diabetes mellitus
- Participation in another simultaneous medical investigation or trial Renal failure requiring dialysis or renal transplant or liver dysfunction History of other disease,or other findings giving reasonable suspicion of a disease or condition that contraindicates the use an investigational drug, might affect interpretation of the results of the study, or render the subject at high risk from treatment complications.
- IOP over 30 mmHg.
- Any previous retinal laser photocoagulation to the study eye in treatment naive. Any previous intravitreal injection in study eye (triamcinolone or other) in treatment naive.
- Any previous vitrectomy in study eye (posterior or anterior associated with vitreous loss in cataract surgery).
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 |
|---|---|---|
| LONGEVINEXlet everyone of the participants oral 1 capsule containing 100 mg LONGEVINEX | Drug | LONGEVINEX |
| placebolet everyone of the participants oral 1 capsule containing 100 mg placebo | Drug | placebo |
Primary outcome
Choroidal Thickness(micrometer)
Time frame: baseline
using Heidelberg Eye Explorer software to measure choroidal thickness of participants
1 secondary outcome
Choroidal Thickness(micrometer)
Time frame: 1 hour after baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2015.
Related trials for Eye Disease
Active, not recruitingPhase 3
ENDOTHELION Study Group: Effect of Bosentan in NAION Patients
Ischemic Optic Neuropathy
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
Recruiting
Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
Pre-myopia, Myopia
Active, not recruiting
Improving Visual Field Deficits With Noninvasive Brain Stimulation
Visual Field Defect, Peripheral, Stroke
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.
Xunfang Sun study director
Department of Ophthalmology,Tongji Hospital, Tongji Medical College, Huazhong University of science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LONGEVINEX in people with Eye Disease, run by Huazhong University of Science and Technology at 1 site in China.
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 4 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: status not confirmed, as of the sponsor's last update on 3 Apr 2015. 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 China. 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. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shuaishuai Wang (15623422892, 949990624@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Choroidal Thickness(micrometer) (time frame: baseline). 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 3 Apr 2015.