Primary Open Angle GlaucomaNCT04334564
Effect of Ginkgo Biloba Capsule on Visual Function of Primary Open-angle Glaucoma With Blood Stasis Syndrome
A study testing Ginkgo biloba capsule in people with Primary Open Angle Glaucoma and Drug Effect, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Primary Open Angle Glaucoma, Drug Effect
- What is being tested?
- Ginkgo biloba capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 512 participants
- Where
- 1 siteChina
- Study dates
- 28 Apr 2015to 30 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhognshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510060
Chengguo Zuo, M.D,Ph.D, 02066615461, chengguozuo@163.com
Jian Ge, M.D,Ph.D, 02066615461, gejian@mail.sysu.edu.cn
About this study
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
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.
- Conditions
- Primary Open Angle Glaucoma, Drug Effect
- Being tested
- Ginkgo biloba capsule, Placebos
- Keywords
- Primary Open Angle Glaucoma, Ginkgo biloba capsule
- Medical subject headings
- Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ginkgo biloba capsuleDrug
Ginkgo biloba capsule may improve visual function of primary open-angle glaucoma by repairing of the optic nerve.
PlacebosDrug
Placebos were controls.
| Study group | Role | What they receive |
|---|---|---|
| Test team | Active comparator | Patients were treated with ginkgo biloba capsule regularly. Take 2 capsules 3 times a day, orally Receives: Drug: Ginkgo biloba capsule |
| Control group | Placebo comparator | Patients were treated with placebo regularly.Take 2 capsules 3 times a day, orally Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean defect of visual field (MD)
Detection by humphrey visual field meter
Measured: After 48 weeks of treatment
Secondary outcomes (1)
Retinal nerve fiber layer thickness (RNFL)
Detection by optical coherence tomography (OCT)
Measured: After 12, 24, 36, and 48 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2020
- Study start28 Apr 2015
- Primary completion30 Oct 2020 (estimated)
- Study completion30 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Open Angle GlaucomaStudies of the same condition, open and under way.
- More trials run by Zhongshan Ophthalmic Center, Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 512 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jian Ge, M.D,Ph.D, Study chair, Zhognshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04334564
- Sponsor's protocol ID
- 2015YWNL001
- Status last verified
- Apr 2020
- First submitted
- 1 Apr 2020
- Last updated
- 6 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04334564
- Acronym / sponsor ID
- 2015YWNL001
- Conditions
- Primary Open Angle Glaucoma, Drug Effect
- Keywords
- Primary Open Angle Glaucoma, Ginkgo biloba capsule
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 512 participants (estimated)
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 28 Apr 2015 (actual)
- Primary completion
- 30 Oct 2020 (estimated)
- Study completion
- 30 Nov 2020 (estimated)
- First posted
- 6 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test team | Active comparator | Drug: Ginkgo biloba capsulePatients were treated with ginkgo biloba capsule regularly. Take 2 capsules 3 times a day, orally |
| Control group | Placebo comparator | Drug: PlacebosPatients were treated with placebo regularly.Take 2 capsules 3 times a day, orally |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ginkgo biloba capsuleGinkgo biloba capsule may improve visual function of primary open-angle glaucoma by repairing of the optic nerve. | Drug | Test team |
| PlacebosPlacebos were controls. | Drug | Control group |
Primary outcome
Mean defect of visual field (MD)
Time frame: After 48 weeks of treatment
Detection by humphrey visual field meter
1 secondary outcome
Retinal nerve fiber layer thickness (RNFL)
Time frame: After 12, 24, 36, and 48 weeks of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2020.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jian Ge, M.D,Ph.D study chair
Zhognshan Ophthalmic Center, Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ginkgo biloba capsule in people with Primary Open Angle Glaucoma and Drug Effect, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chengguo Zuo, M.D,Ph.D (020-66615461, chengguozuo@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean defect of visual field (MD) (time frame: After 48 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2020.