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

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

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.

Study Overview

• Status: Unknown
• Conditions: Primary Open Angle Glaucoma; Drug Effect
• Intervention / Treatment: Drug: Ginkgo biloba capsule; Drug: Placebos

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.

• Study Type: Interventional
• Enrollment (Anticipated): 512
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Recruiting
      • Zhognshan Ophthalmic Center, Sun Yat-sen University
      • Contact: Chengguo Zuo, M.D,Ph.D; Phone Number: 02066615461; Email: chengguozuo@163.com
      • Contact: Jian Ge, M.D,Ph.D; Phone Number: 02066615461; Email: gejian@mail.sysu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 26 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Test team; Patients were treated with ginkgo biloba capsule regularly. Take 2 capsules 3 times a day, orally	Drug: Ginkgo biloba capsule; Ginkgo biloba capsule may improve visual function of primary open-angle glaucoma by repairing of the optic nerve.
Placebo Comparator: Control group; Patients were treated with placebo regularly.Take 2 capsules 3 times a day, orally	Drug: Placebos; Placebos were controls.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean defect of visual field (MD)	Detection by humphrey visual field meter	After 48 weeks of treatment

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University
• Investigators: Study Chair: Jian Ge, M.D,Ph.D, Zhognshan Ophthalmic Center, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2015
• Primary Completion (Anticipated): October 30, 2020
• Study Completion (Anticipated): November 30, 2020

Study Registration Dates

• First Submitted: April 1, 2020
• First Submitted That Met QC Criteria: April 1, 2020
• First Posted (Actual): April 6, 2020

Study Record Updates

• Last Update Posted (Actual): April 6, 2020
• Last Update Submitted That Met QC Criteria: April 1, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Primary Open Angle Glaucoma; Ginkgo biloba capsule
• Additional Relevant MeSH Terms: Digestive System Diseases; Metabolic Diseases; Eye Diseases; Ocular Hypertension; Gastrointestinal Diseases; Intestinal Diseases; Malabsorption Syndromes; Glaucoma; Glaucoma, Open-Angle; Blind Loop Syndrome
• Other Study ID Numbers: 2015YWNL001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: The archived documents and materials are not loaned. If the management department needs to access the original data, it should be agreed by the PI of the project.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No