The Effect of Resveratrol Based Nutritional Supplement on Choroidal Thickness

NCT02321189 | Unknown DMC

• 1 other identifier: Sun3
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Eye Disease

Outcome Measures

Primary Outcomes (1)

• Choroidal Thickness(micrometer)

  using Heidelberg Eye Explorer software to measure choroidal thickness of participants

  baseline

Secondary Outcomes (1)

• Choroidal Thickness(micrometer)

  1 hour after baseline

Study Arms (2)

LONGEVINEX

PLACEBO COMPARATOR

The Effect of LONGEVINEX on Choroidal Thickness

Drug: LONGEVINEX

placebo

PLACEBO COMPARATOR

The Effect of placebo on Choroidal Thickness

Drug: placebo

Interventions

LONGEVINEX DRUG

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

LONGEVINEX

placebo DRUG

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

placebo

Eligibility Criteria

• Age: 23 Years - 28 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead

Study Sites (1)

Tongji Medical College of HUST

Wuhan, Hubei, China

RECRUITING

MeSH Terms

Conditions

Eye Diseases

Study Officials

• Xunfang Sun

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

  STUDY DIRECTOR

Central Study Contacts

Shuaishuai Wang

CONTACT

15623422892; 949990624@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: study director

Study Record Dates

• First Submitted: November 8, 2014
• First Posted: December 22, 2014
• Study Start: October 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: April 3, 2015

Record last verified: 2015-04

Locations

CN (1)