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

Primary Purpose

Primary Open Angle Glaucoma, Drug Effect

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Ginkgo biloba capsule

Placebos

About this trial

This is an interventional treatment trial for Primary Open Angle Glaucoma focused on measuring Primary Open Angle Glaucoma, Ginkgo biloba capsule

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Zhognshan Ophthalmic Center, Sun Yat-sen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Test team

Control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Mean defect of visual field (MD)

Detection by humphrey visual field meter

Secondary Outcome Measures

Retinal nerve fiber layer thickness (RNFL)

Detection by optical coherence tomography (OCT)

Full Information

NCT ID

NCT04334564

First Posted

April 1, 2020

Last Updated

April 1, 2020

Sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University

1. Study Identification

Unique Protocol Identification Number

NCT04334564

Brief Title

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

Official Title

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

Interventional

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Unknown status

Study Start Date

April 28, 2015 (Actual)

Primary Completion Date

October 30, 2020 (Anticipated)

Study Completion Date

November 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Primary Open Angle Glaucoma, Drug Effect

Keywords

Primary Open Angle Glaucoma, Ginkgo biloba capsule

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

512 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Test team

Arm Type

Active Comparator

Arm Description

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

Arm Title

Control group

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Ginkgo biloba capsule

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebos

Intervention Description

Placebos were controls.

Primary Outcome Measure Information:

Title

Mean defect of visual field (MD)

Description

Detection by humphrey visual field meter

Time Frame

After 48 weeks of treatment

Secondary Outcome Measure Information:

Title

Retinal nerve fiber layer thickness (RNFL)

Description

Detection by optical coherence tomography (OCT)

Time Frame

After 12, 24, 36, and 48 weeks of treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Chengguo Zuo, M.D,Ph.D

Phone

020-66615461

chengguozuo@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

Jian Ge, M.D,Ph.D

Phone

020-66615461

gejian@mail.sysu.edu.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jian Ge, M.D,Ph.D

Organizational Affiliation

Zhognshan Ophthalmic Center, Sun Yat-sen University

Official's Role

Study Chair

Facility Information:

Facility Name

Zhognshan Ophthalmic Center, Sun Yat-sen University

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510060

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Chengguo Zuo, M.D,Ph.D

Phone

02066615461

chengguozuo@163.com

First Name & Middle Initial & Last Name & Degree

Jian Ge, M.D,Ph.D

Phone

02066615461

gejian@mail.sysu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing 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.

Learn more about this trial

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

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