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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

480 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2022-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Otologic Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Panfoshu + conventional treatment group（program-A）

Panfoshu 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.

Group Type EXPERIMENTAL

Panfoshu+Conventional Treatment（program-A）

Intervention Type DRUG

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 group（program-B）

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.

Group Type EXPERIMENTAL

Panfoshu+Conventional Treatment（program-B）

Intervention Type DRUG

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.

conventional treatment group

Conventional medications are used to treat the relavant ear and nose symptoms.

Group Type OTHER

Conventional Treatment

Intervention Type OTHER

Patients in this group were treated with only the conventional treatment.

Interventions

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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.

Intervention Type DRUG

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.

Intervention Type DRUG

Conventional Treatment

Patients in this group were treated with only the conventional treatment.

Intervention Type OTHER

Other Intervention Names

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Bacteriolysis product Bacteriolysis product

Eligibility Criteria

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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

Minimum Eligible Age

1 Year

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No