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A Randomized Controlled Clinical Trial of Qujia Hualiu Granules in Treating Orbital Inflammatory Pseudotumor with Heat-Toxin Stagnation Pattern

A Randomized Controlled Clinical Trial of Qujia Hualiu Granules in Treating Orbital Inflammatory Pseudotumor with Heat-Toxin Stagnation Pattern

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000948
Enrollment
Unknown
Registered
2025-05-10
Start date
2023-03-02
Completion date
Unknown
Last updated
2025-05-26

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

Conditions

Orbital Inflammatory Pseudotumor

Interventions

Positive control:Treatment with oral prednisone acetate tablets
Experimental group:Oral "Qujia Hualiu Formula" combined with glucocorticoids

Sponsors

China Academy of Chinese Medical Sciences Ophthalmology Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1)No gender restriction aged 18–75 years voluntarily participating in this study. (2)Diagnosed with orbital inflammatory pseudotumor (OIPT) based on clinical manifestations medical history imaging examinations and/or pathological confirmation. (3)Signed informed consent with good compliance able to adhere to medication protocols and follow-up schedules as required by the clinical trial. (4)No significant abnormalities detected on ophthalmic specialist examinations.

Exclusion criteria

Exclusion criteria: (1)Patients with severe cardiovascular/cerebrovascular diseases or severe primary disorders of the liver kidneys or hematopoietic system. (2)Those with other orbital diseases (e.g. lymphoma orbital cellulitis rhabdomyosarcoma Graves ophthalmopathy). (3)Patients with psychiatric conditions (e.g. anxiety depression) or other mental disorders. (4)Individuals with allergic constitutions or hypersensitivity to the study drugs/components. (5)Pregnant women those planning pregnancy or lactating mothers. (6)Subjects deemed ineligible by investigators based on clinical judgment.

Design outcomes

Primary

MeasureTime frame
Intercellular adhesion molecule-1;Immunoglobulin G4(IgG4);Orbital CT;Exophthalmometry;

Secondary

MeasureTime frame
Strabismus angle (9 gaze positions);Intraocular pressure;vision;Interleukin-6(IL-6);ocular ultrasound;Tumor necrosis factor-a(TNF-a);

Countries

China

Contacts

Public ContactLike Xie

China Academy of Chinese Medical Sciences Ophthalmology Hospital

bjxielike@sina.com13466782818

Outcome results

None listed

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