Clinical Effect of Panfoxol of Otolaryngological Diseases of Upper Respiratory Tract Infection: A Multicenter Retrospective Observational Study
1 other identifier
interventional
480
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedFirst Submitted
Initial submission to the registry
February 20, 2023
CompletedFirst Posted
Study publicly available on registry
April 10, 2023
CompletedApril 10, 2023
February 1, 2023
2 years
February 20, 2023
March 28, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Number of participants with treatment-related adverse events
through study completion, an average of 6 months
Types, occurence rate and duration of the treatment-related adverse events
through study completion, an average of 6 months.
Study Arms (3)
Panfoshu + conventional treatment group（program-A）
EXPERIMENTALPanfoshu is commonly known as the product of bacterial dissolution. it was taken orally once a day on an empty stomach, one capsule at a time. 1 course of treatment was 6mon, which was taken 10 days a month, stopped for 20 days for 3 months, and observed for another 3 months(unmedicated). Usage and dosage: adults and adolescents above 12yrs take one capsule (7.0mg) every day, children (1yrs-12yrs) take one capsule (3.5mg) every day.
Panfoshu + conventional treatment group（program-B）
EXPERIMENTALPanfoshu was taken for 30 days in the first month, stopped in the second month, taken for 10 days and stopped for 20 days in a row for 3 months, and finally observed for 1 month. Usage and dosage: adults and adolescents above 12yrs take one capsule (7.0mg) every day, children (1yrs-12yrs) take one capsule (3.5mg) every day.
conventional treatment group
OTHERConventional medications are used to treat the relavant ear and nose symptoms.
Interventions
On the basis of conventional treatment, panfoshu combined therapy was added.Panfoshu was taken orally once a day on an empty stomach, one capsule at a time. 1 course of treatment was 6mon, which was taken 10 days a month, stopped for 20 days for 3 months, and observed for another 3 months(unmedicated). Usage and dosage: adults and adolescents above 12yrs take one capsule (7.0mg) every day, children (1yrs-12yrs) take one capsule (3.5mg) every day.
On the basis of conventional treatment, panfoshu combined therapy was added.Panfoshu was taken for 30 days in the first month, stopped in the second month, taken for 10 days and stopped for 20 days in a row for 3 months, and finally observed for 1 month. Usage and dosage: adults and adolescents above 12yrs take one capsule (7.0mg) every day, children (1yrs-12yrs) take one capsule (3.5mg) every day.
Patients in this group were treated with only the conventional treatment.
Eligibility Criteria
You may qualify if:
- 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
- Complete clinical data were available at least once both before and after treatment
You may not qualify if:
- Patients who are allergic to the ingredient panfosol
- Autoimmune disease
- Acute intestinal infection
- Children younger than 1 year old
- Patients diagnosed with nasopharyngeal carcinoma and other space-occupying diseases by imaging examination
- Basic information is incomplete
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sun Yat-sen Memorial Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 20, 2023
First Posted
April 10, 2023
Study Start
January 1, 2021
Primary Completion
December 31, 2022
Study Completion
December 31, 2022
Last Updated
April 10, 2023
Record last verified: 2023-02