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The test purpose is to evaluate and confirm the safety and efficacy of treatment for ocular fundus bleeding in AMD (syndrome of Yin deficiency &liver hyperactivity and heat injury of collaterals) using this drug.

ZHI XUE QU YUE MING MU PIAN Treatment to Ocular Fundus Hemorrhage Age-related Macular Degeneration (Syndrome of Yin Deficiency &Liver Hyperactivity and Heat Injury of Collaterals)

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-14004562
Enrollment
Unknown
Registered
2014-04-21
Start date
2014-05-31
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ocular Fundus Hemorrhage Age-related Macular Degeneration (Syndrome of Yin Deficiency &Liver Hyperactivity and Heat Injury of Collaterals)

Interventions

test group:ZHI XUE QU YUE MING MU PIAN
placebo group:Subjects was injected ranibizumab once 2 week ago, and after recruitment of the study, will oral this drug 5 tablets once, three times a day
Experimental treatment group:Subjects who never received ranibizumab who will oral this drug 5 tablets once, three time a day

Sponsors

Peking Union Medical College Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
45 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients with at least one eye meeting AMD Western Medicine diagnostic criteria and clinical exudation (wet) accompanied by definite hemorrhage; 2. Patients meeting the criteria of differentiation for syndrome of Yin deficiency of liver and heat injury of collaterals; 3. Aged 45-80 years; 4. Best corrected visual acuity measured in the eye chart: The inspection is made using the eye chart in the diabetes research institute (in early treatment); letters in this chart are clearly seen and visual acuity is between 0.1 (including 0.1)~ 0.6; 5. Patients only receiving one-time ranibizumab injection 2 week ago; 6. Patients with active new blood vessels located under macular central fovea and near central fovea; 7. Refractive stroma being generally clear and not interfering with ocular fundus examination and fluorescein ocular fundus angiography; 8. Patients having good adherence in curative effect observation and evaluation by the researchers; 9. Subjects who do not attend other clinical trials within 2-4 weeks before treatment; 10. Subjects who sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Combined high myopia, diabetic retinopathy, glaucoma, retinal vein and artery occlusion, optic neuropath (optic neuritis, atrophy, papillary edema), macular hole and other ocular fundus diseases; 2. Patients diagnosed by ICGA to be with PCV, RAP, and PED; 3. Patients with complete scars due to AMD but without bleeding or exudation; 4. Patients have vagus ocular fundus refractive stroma (vitreous hemorrhage, cataracts and so forth) which influences ocular fundus observation; 5. Patients with combined severe diseases in cardio-cerebrovessels, liver, kidney and hematopoietic systems; 6. Patients unable to adhere to the standards of treatment; 7. Psychiatric patients; 8. Patients with serious allergies due to fluorescein sodium injection; 9. Patients who are taking part in other drug clinical trials; patients having a concurrent use with similar Chinese medicines and other treatments; or patients exiting mid-way.

Design outcomes

Primary

MeasureTime frame
Number of letters seen in ETDRS Chart after vision;

Countries

China

Contacts

Public ContactPengMao

Shanxi Momentum Pharmaceutcal Company

haxmp@aliyun.com+86 029-88608088

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026