Otologic Disease Clinical Trial
Official title:
Clinical Effect of Panfoxol of Otolaryngological Diseases of Upper Respiratory Tract Infection: A Multicenter Retrospective Observational Study
Verified date | February 2023 |
Source | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Patients with otolaryngological diseases caused by upper respiratory tract infections, including allergic rhinitis, chronic rhinosinusitis, secretory otitis media, and oblate gland hypertrophy, were treated with all drugs from Sun Yat-sen Memorial Hospital of Sun Yat-sen University, the First Affiliated Hospital of Sun Yat-sen University, Guangdong Provincial People's Hospital, and Guangdong Provincial Hospital of Traditional Chinese Medicine from January 2021 to December 2022. According to the treatment methods, the patients were divided into panfosol + conventional treatment group and conventional treatment group for multicenter retrospective analysis.
Status | Completed |
Enrollment | 480 |
Est. completion date | December 31, 2022 |
Est. primary completion date | December 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Year to 70 Years |
Eligibility | Inclusion Criteria: 1. those who were diagnosed as ear, nose and throat diseases caused by upper respiratory tract infection, such as allergic rhinitis, chronic rhinosinusitis, secretory otitis media, and oblate gland hypertrophy 2. Complete clinical data were available at least once both before and after treatment Exclusion Criteria: 1. Patients who are allergic to the ingredient panfosol 2. Autoimmune disease 3. Acute intestinal infection 4. Children younger than 1 year old 5. Patients diagnosed with nasopharyngeal carcinoma and other space-occupying diseases by imaging examination 6. Basic information is incomplete |
Country | Name | City | State |
---|---|---|---|
China | Sun Yat-sen Memorial Hospital of Sun Yat-sen University | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Therapeutic effective rate | Treatment outcomes were classified as cure, effective, ineffective and relapse according to the condition after treatment. A cure means that the disease is under complete control, meaning that the patient's symptoms disappear completely and no medication is needed to continue treatment. Effective represents partial control of the disease, in which the patient's symptoms improve significantly but still require medication. Ineffective means the disease is not controlled or the symptoms are aggravated. Effective patients have symptoms aggravated, and the recurrence of symptoms after cure is defined as relapse. | through study completion, an average of 6 months. | |
Secondary | Number of participants with treatment-related adverse events | All participants were reviewed for gastrointestinal disturbances (nausea, abdominal pain, vomiting), skin reactions (rash, urticaria), respiratory discomfort (cough, dyspnea, asthma), and common problems (fever, fatigue, allergic reactions) after medication. Count the number of patients with these adverse symtoms. | through study completion, an average of 6 months | |
Secondary | Types, occurence rate and duration of the treatment-related adverse events | All participants were reviewed for gastrointestinal disturbances (nausea, abdominal pain, vomiting), skin reactions (rash, urticaria), respiratory discomfort (cough, dyspnea, asthma), and common problems (fever, fatigue, allergic reactions) after medication. The presentation and duration of adverse symptoms in patients were counted. | through study completion, an average of 6 months. |
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