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A randomized, open label, positive drug controlled clinical trial about anisodine hydrobromide injection on the treatment of ischemic optic neuropathy

A randomized, open label, positive drug controlled clinical trial about anisodine hydrobromide injection on the treatment of ischemic optic neuropathy

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-16008021
Enrollment
Unknown
Registered
2016-02-29
Start date
2016-02-20
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

Ischemic Ooptic Neuropathy

Interventions

the group of hydrobromide anisodine:Intravenous infusion, 2mg / day
the group of xuesetong injection (lyophilized):Intravenous infusion, 400mg / day

Sponsors

Sichuan Provincial People‘s Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. The patients who are primary ocular ischemic lesions. 2. The patients whose duration don't exceed 3 months; 3. The patients whose age are 18-65, including men and women; 4. The patients who could understand and voluntarily sign ICF.

Exclusion criteria

Exclusion criteria: 1. The patients who have other severe eye disease which would influence visual functionsuch as glaucoma, corneal inflammation and opacity, uveitis, clear lens opacity, diabetic proliferative retinopathy, temporal arteritic anterior ischemic neuropathy, macular hole, retinal detachment, retinitis pigmentosa; 2. The patients who have brain hemorrhage and optic canal fracture; 3. The patients who have no light perception over a week; 4. The patients who have severe heart disease, severe arrhythmia, heart failure; 5. The patients who have severe hypertension or severe lipid metabolic disorders; 6. The patients whose Liver and kidney function are severely abnormal (ALT> 1.5 ULN, Cr> 1.5 ULN); 7. The patients who are taking drugs with plaque formation by transcranial Doppler; 8. The patients who are allergies, and allergic to two or more drugs or food, or allergy to the drug ingredient; 9. The patients who already pregnant, would plan to pregnancy or breast-feeding women; 10. The patients who had participate in other clinical trials over the past three months; 11.The patients is not suitable to participate in this study who the researchers determine.

Design outcomes

Primary

MeasureTime frame
The total effective rate of disease;

Secondary

MeasureTime frame
Vision Rating;Perspective ratings;Visual evoked potentials;

Contacts

Public ContactWu Zhengzheng
wuzz7029@163.com+86 18981838925

Outcome results

None listed

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