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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

512 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-28

Study Completion Date

2020-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Measurement of the Effect of Gingko Biloba Extract on Ocular and Nailfold Blood-flow in NTG

NCT03761992

Normal Tension Glaucoma

UNKNOWN NA

Impact of Oral Versatile Antioxidants on Glaucoma Progression

NCT01544192

Glaucoma

COMPLETED PHASE3

To Evaluate the Effect of Ginkgo Biloba Extract on Optic Nerve Head Perfusion Examined Using OCTA

NCT04846179

Glaucoma

COMPLETED PHASE4

The Effects of an Antioxidant Formulation on Ocular Blood Flow

NCT01930487

Primary Open Angle Glaucoma

COMPLETED NA

GlaucoT Glaucoma Treatment Glasses in the Treatment of Primary Open-Angle Glaucoma

NCT05253534

Primary Open-Angle Glaucoma

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Primary Open Angle Glaucoma Drug Effect

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Test team

Patients were treated with ginkgo biloba capsule regularly. Take 2 capsules 3 times a day, orally

Group Type ACTIVE_COMPARATOR

Ginkgo biloba capsule

Intervention Type DRUG

Ginkgo biloba capsule may improve visual function of primary open-angle glaucoma by repairing of the optic nerve.

Control group

Patients were treated with placebo regularly.Take 2 capsules 3 times a day, orally

Group Type PLACEBO_COMPARATOR

Placebos

Intervention Type DRUG

Placebos were controls.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ginkgo biloba capsule

Ginkgo biloba capsule may improve visual function of primary open-angle glaucoma by repairing of the optic nerve.

Intervention Type DRUG

Placebos

Placebos were controls.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No