ClinicalTrials.gg
Status unknownNCT04334564Updated Apr 6, 2020

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

An interventional study of Ginkgo biloba capsule and Placebos in Primary Open Angle Glaucoma and Drug Effect, sponsored by Zhongshan Ophthalmic Center, Sun Yat-sen University. Status unknown at 1 site in China. Open to participants aged 30 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-04-06.

Sponsored by Zhongshan Ophthalmic Center, Sun Yat-sen University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2020), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 4 years 11 months after the study started (first participant enrolled Apr 2015, registered Apr 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
512
Allocation
Randomized
Ages
30 Years to 65 Years
Sex
All
01

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.

Read the 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.

02

Conditions studied

  • Primary Open Angle Glaucoma
  • Drug Effect

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Keywords

  • Primary Open Angle Glaucoma
  • Ginkgo biloba capsule
03

In context

Glaucoma, Open-Angle

943 studies on the registry are indexed under Glaucoma, Open-Angle; 118 are open to participants now.

This study's planned enrollment of 512 is above the median of 80 across 710 interventional studies indexed under Glaucoma, Open-Angle.

Browse Glaucoma, Open-Angle studies →

Lead sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University is the lead sponsor of 164 studies on the registry; 80 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
512 participants (estimated)

Study arms

  • Active comparator
    Test team

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

    Drug: Ginkgo biloba capsule

  • Placebo comparator
    Control group

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

    Drug: Placebos

Interventions

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

  • DrugPlacebos

    Placebos were controls.

06

What researchers measure

Primary outcomes

  1. Mean defect of visual field (MD)

    Detection by humphrey visual field meter

    Time frame: After 48 weeks of treatment

Secondary outcomes

  1. Retinal nerve fiber layer thickness (RNFL)

    Detection by optical coherence tomography (OCT)

    Time frame: After 12, 24, 36, and 48 weeks of treatment

07

Study locations

1 of 1 sites recruiting
  • Zhognshan Ophthalmic Center, Sun Yat-sen University
    Guangzhou, Guangdong 510060, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No — 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.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 6, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04334564
Responsible party
Sponsor
First posted
Apr 6, 2020
Start date
Apr 28, 2015
Primary completion
Oct 30, 2020 (estimated)
Completion
Nov 30, 2020 (estimated)
Last update
Apr 6, 2020

Study contacts

Chengguo Zuo, M.D,Ph.D
Contact
chengguozuo@163.com
020-66615461
Jian Ge, M.D,Ph.D
Contact
gejian@mail.sysu.edu.cn
020-66615461
Jian Ge, M.D,Ph.D
study chair · Zhognshan Ophthalmic Center, Sun Yat-sen University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

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