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Completed

NCT Number: NCT05806086

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

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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Key information

Conditions

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

Age range

1 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sun Yat-sen Memorial Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Panfoshu+Conventional Treatment（program-A）

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.

Other names: Bacteriolysis product

Panfoshu+Conventional Treatment（program-B）

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.

Other names: Bacteriolysis product

conventional treatment

Other

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

Primary outcomes

  1. Therapeutic effective rate

    Time frame: through study completion, an average of 6 months.

    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.

Secondary outcomes

  1. Number of participants with treatment-related adverse events

    Time frame: through study completion, an average of 6 months

    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.

  2. Types, occurence rate and duration of the treatment-related adverse events

    Time frame: through study completion, an average of 6 months.

    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.

Sponsors and collaborators

Lead sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 10, 2023
Registry last updated
Apr 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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