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

Phase

N/A

Condition

Open Angle Glaucoma

Glaucoma

Treatment

N/A

Clinical Study ID

NCT04334564

2015YWNL001

Ages 30-65
All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

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

Study Design

April 28, 2015

November 30, 2020

Study 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.

Connect with a study center

Zhognshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong 510060
China
Active - Recruiting

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