Orbital Inflammatory Pseudotumor
Conditions
Interventions
Traditional Chinese Medicine Group:Oral "Qujia Hualiu Formula"
Western Medicine Group:Treatment with oral prednisone acetate tablets
Combined Group:Oral "Qujia Hualiu Formula" combined with prednisone acetate tablets
Sponsors
China Academy of Chinese Medical Sciences Ophthalmology Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Meets the diagnostic criteria for orbital inflammatory pseudotumor and traditional Chinese medicine syndrome diagnosis. (2) Gender is not limited, patients aged 18 to 75 years old. (3) Has not participated in other drug clinical studies within the past 3 months.
Exclusion criteria
Exclusion criteria: (1) Patients with severe cardiovascular and cerebrovascular diseases, serious primary diseases of the liver, kidney, or hematopoietic system. (2) Orbital inflammatory pseudotumor is a diagnostic exclusion, requiring the exclusion of other orbital inflammatory reactions caused by tumors, infections, or specific reasons, such as lymphoma, some malignant tumors, orbital cellulitis, Graves' ophthalmopathy, IgG4-related ophthalmopathy, intraorbital abscesses, and other orbital diseases. (3) Systemic immune diseases such as Sjögren's syndrome, systemic lupus erythematosus, rheumatoid arthritis, etc. (4) Patients with a history of allergy or suspected allergic reaction to the components contained in the investigational drug. (5) Patients who have undergone eye surgery such as glaucoma, cataract, vitrectomy, pterygium within three months. (6) Pregnant or breastfeeding women. (7) Patients who are participating in other drug clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Exophthalmometry;Clinical symptom score ; | — |
Secondary
| Measure | Time frame |
|---|---|
| ocular ultrasound;Orbital CT;vision;Intraocular pressure;Palpebral fissure height;Traditional Chinese Medicine symptom evaluation;Peripheral blood immune cell subsets;Peripheral blood inflammatory factor analysis;Tear inflammatory factor analysis;Strabismus angle (9 gaze positions); | — |
Countries
China
Contacts
Public ContactHao xiaofeng
China Academy of Chinese Medical Sciences Ophthalmology Hospital
Outcome results
None listed