Clinical Effect of Panfoxol of Otolaryngological Diseases of Upper Respiratory Tract Infection: A Multicenter Retrospective Observational Study

Otologic Disease Clinical Trial

Official title:

Clinical Effect of Panfoxol of Otolaryngological Diseases of Upper Respiratory Tract Infection: A Multicenter Retrospective Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05806086
• Other study ID #: SYSKY-2022-087-01
• Status: Completed
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: February 2023
• Source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

FIrstly, Data of all patients were collected before and after treatment, including nasal endoscopy Lund Kennedy score, VAS scale for nasal/facial/olfactory symptoms, and ear/nose/snoring VAS scale, etc. According to the change values before and after treatment, the treatment results were divided into cure (complete control of the disease), effective (partial control of the disease), ineffective (uncontrolled disease). secondly, 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Ear Diseases
• Infections
• Otologic Disease
• Otorhinolaryngologic Diseases
• Respiratory Tract Infections

Intervention

Drug:
• Panfoshu+Conventional Treatment(program-A)
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.
• Panfoshu+Conventional Treatment(program-B)
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.

Other:
• Conventional Treatment
Patients in this group were treated with only the conventional treatment.

Locations

Country	Name	City	State
China	Sun Yat-sen Memorial Hospital of Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

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.