Effect of Ginkgo Biloba Capsule on Visual Function of Primary Open-angle Glaucoma With Blood Stasis Syndrome

Overview

Primary Open Angle Glaucoma (POAG) is an eye disease that causes optic nerve damage, visual field defect, and blindness caused by increased intraocular pressure. In recent years, many studies have shown that ginkgo biloba extract has a protective effect on the visual function of glaucoma patients. Studies have shown that Ginkgo biloba capsules can improve the visual field damage of glaucoma controlled by intraocular pressure;Ginkgo biloba capsule can promote the recovery of visual evoked potential of glaucoma controlled by intraocular pressure; the improvement of visual field has a certain correlation with visual electrophysiological recovery. The mechanism may be achieved by suppressing the influx of calcium ions and thereby inhibiting the apoptosis of cells. Therefore, in this clinical study, effect of Ginkgo biloba capsule on visual function of primary open-angle glaucoma with blood stasis syndrome was evaluated by placebo as control.

Full Title of Study: “Effect of Ginkgo Biloba Capsule on Visual Function of Primary Open-angle Glaucoma With Blood Stasis Syndrome: a Randomized, Double-blind, Placebo Parallel Control, Multicenter Clinical Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: October 30, 2020

Detailed Description

In this clinical study, the visual field, including MD, MS, LV, and vision score, are the main efficacy indicators. HRT and visual electrophysiological examination are the secondary efficacy indicators. Safety indicators based on laboratory tests and total frequency and incidence of adverse events. To evaluate the effectiveness and safety of Ginkgo biloba capsules for glaucoma patients with intraocular pressure control.

Interventions

  • Drug: Ginkgo biloba capsule
    • Ginkgo biloba capsule may improve visual function of primary open-angle glaucoma by repairing of the optic nerve.
  • Drug: Placebos
    • Placebos were controls.

Arms, Groups and Cohorts

  • Active Comparator: Test team
    • Patients were treated with ginkgo biloba capsule regularly. Take 2 capsules 3 times a day, orally
  • Placebo Comparator: Control group
    • Patients were treated with placebo regularly.Take 2 capsules 3 times a day, orally

Clinical Trial Outcome Measures

Primary Measures

  • Mean defect of visual field (MD)
    • Time Frame: After 48 weeks of treatment
    • Detection by humphrey visual field meter

Secondary Measures

  • Retinal nerve fiber layer thickness (RNFL)
    • Time Frame: After 12, 24, 36, and 48 weeks of treatment
    • Detection by optical coherence tomography (OCT)

Participating in This Clinical Trial

Inclusion Criteria

  • 1. Accord with the diagnostic criteria of primary open-angle glaucoma.
  • 2. Accord with the standard of blood stasis and collateralization syndrome in traditional Chinese medicine (TCM).
  • 3. Intraocular pressure ≤ 18mmHg
  • 4. AGIS score of visual field defect ≥ 6 points and ≤ 17 points, cup to disc ratio > 0.6, central corrected visual acuity ≥ 0.3.

Exclusion Criteria

  • 1. The diagnoses of angle closure glaucoma, absolute glaucoma, glaucoma ciliary body syndrome, high intraocular pressure (IOP) and secondary glaucoma.
  • 2. Patients with various fundus diseases, such as retinal detachment, retinal vein occlusion, retinal pigmented degeneration, blood or vascular diseases.
  • 3. Complicated with cornea, iris, visible lens lesion, or one-eye patient.
  • 4. Patients who need to use improved circulation, nutritional nerve drugs during the trial.
  • 5. Any eye surgery or laser therapy during the induction period.
  • 6. Patients with a history of eye infection during the introduction period.
  • 7. Complicated with severe liver and kidney diseases, or abnormal examination of liver and kidney function (ALT,AST ≥ normal upper limit 1.5 times, SCr > normal upper limit).
  • 8. Complicated with severe heart and lung diseases (such as bronchial asthma or history of bronchial asthma, chronic obstructive pulmonary disease, bronchospasm, respiratory failure, etc.), diabetes, advanced tumors, blood and hematopoietic system diseases, or other serious or progressive diseases of the system.
  • 9. A person who is prone to bleeding, or who has suffered severe bleeding during the period of introduction.
  • 10. Pregnant, lactating women or recent birth plans.
  • 11. Other conditions considered inappropriate by the investigator.
  • 12. Patients who participated in other clinical trials during the introduction period.

Gender Eligibility: All

Minimum Age: 30 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Zhongshan Ophthalmic Center, Sun Yat-sen University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jian Ge, M.D,Ph.D, Study Chair, Zhognshan Ophthalmic Center, Sun Yat-sen University
  • Overall Contact(s)
    • Chengguo Zuo, M.D,Ph.D, 020-66615461, chengguozuo@163.com

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