The Effect of Resveratrol Based Nutritional Supplement on Choroidal Thickness

NCT ID: NCT02321189

Last Updated: 2015-04-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2015-05-31

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: SINGLE

Study Groups

LONGEVINEX

The Effect of LONGEVINEX on Choroidal Thickness

Group Type: PLACEBO_COMPARATOR

LONGEVINEX

Intervention Type: DRUG

let everyone of the participants oral 1 capsule containing 100 mg LONGEVINEX

placebo

The Effect of placebo on Choroidal Thickness

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

let everyone of the participants oral 1 capsule containing 100 mg placebo

Interventions

LONGEVINEX

let everyone of the participants oral 1 capsule containing 100 mg LONGEVINEX

Intervention Type: DRUG

placebo

let everyone of the participants oral 1 capsule containing 100 mg placebo

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Male and female patients 23-28 years of age. nonsmokers.

2. 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.

3. 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.

4. patients should abstain from alcohol-containing beverages at least two days prior to and during the study.

Exclusion Criteria

1. Uncontrolled Blood pressure exceeding diastolic pressure of 100 mm Hg (sitting) during the screening period and uncontrolled diabetes mellitus

2. 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.

3. IOP over 30 mmHg.

4. 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.

5. Any previous vitrectomy in study eye (posterior or anterior associated with vitreous loss in cataract surgery).

6. Intracapsular cataract extraction (posterior capsule needs to be present).

7. 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).

• Minimum Eligible Age: 23 Years
• Maximum Eligible Age: 28 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Huazhong University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Xufang Sun

study director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xunfang Sun

Role: STUDY_DIRECTOR

Department of Ophthalmology,Tongji Hospital, Tongji Medical College, Huazhong University of science and Technology

Locations

Tongji Medical College of HUST

Wuhan, Hubei, China

Site Status: RECRUITING

Countries

China

Central Contacts

Shuaishuai Wang

Role: CONTACT

949990624@qq.com

15623422892

Facility Contacts

Shuaishuai Wang

Role: primary

949990624@qq.com

15623422892

Other Identifiers

Sun3

Identifier Type: -

Identifier Source: org_study_id