Otologic DiseaseNCT05806086
Clinical Effect of Panfoxol of Otolaryngological Diseases of Upper Respiratory Tract Infection: A Multicenter Retrospective Observational Study
A study testing Panfoshu+Conventional Treatment（program-A）, Panfoshu+Conventional Treatment（program-B） and Conventional Treatment in people with Otologic Disease, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 1 year to 70 years
- Conditions the study is for
- Otologic Disease
- What is being tested?
- Panfoshu+Conventional Treatment（program-A）, Panfoshu+Conventional Treatment（program-B） and Conventional Treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Sun Yat-sen Memorial Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510000
About this 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.
Read the detailed 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.
- Conditions
- Otologic Disease
- Being tested
- Panfoshu+Conventional Treatment（program-A）, Panfoshu+Conventional Treatment（program-B）, Conventional Treatment
- Keywords
- Panfoxol, Otologic Disease, Curative Effect, Upper Respiratory Tract Infection (URTI)
- Medical subject headings
- Ear Diseases, Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Panfoshu+Conventional Treatment（program-A）Drug
Also called Bacteriolysis product
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）Drug
Also called Bacteriolysis product
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 TreatmentOther
Patients in this group were treated with only the conventional treatment.
| Study group | Role | What they receive |
|---|---|---|
| Panfoshu + conventional treatment group（program-A） | Experimental | 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. Receives: Drug: Panfoshu+Conventional Treatment（program-A） |
| Panfoshu + conventional treatment group（program-B） | Experimental | 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. Receives: Drug: Panfoshu+Conventional Treatment（program-B） |
| conventional treatment group | Other | Conventional medications are used to treat the relavant ear and nose symptoms. Receives: Other: Conventional Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of 6 months.
Secondary outcomes (2)
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.
Measured: through study completion, an average of 6 months
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.
Measured: through study completion, an average of 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2023
- Study start1 Jan 2021
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Otologic DiseaseStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 480 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05806086
- Sponsor's protocol ID
- SYSKY-2022-087-01
- Status last verified
- Feb 2023
- First submitted
- 20 Feb 2023
- Last updated
- 10 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effect of Panfoxol of Otolaryngological Diseases of Upper Respiratory Tract Infection: A Multicenter Retrospective Observational Study
- ClinicalTrials.gov ID
- NCT05806086
- Acronym / sponsor ID
- SYSKY-2022-087-01
- Conditions
- Otologic Disease
- Keywords
- Panfoxol, Otologic Disease, Curative Effect, Upper Respiratory Tract Infection (URTI)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 480 participants (actual)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 10 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Panfoshu + conventional treatment group（program-A） | Experimental | Drug: Panfoshu+Conventional Treatment（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. |
| Panfoshu + conventional treatment group（program-B） | Experimental | Drug: Panfoshu+Conventional Treatment（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. |
| conventional treatment group | Other | Other: Conventional TreatmentConventional medications are used to treat the relavant ear and nose symptoms. |
Who may qualify
- Ages
- 1 year to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Panfoshu+Conventional Treatment（program-A）Also: Bacteriolysis productOn 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. | Drug | Panfoshu + conventional treatment group（program-A） |
| Panfoshu+Conventional Treatment（program-B）Also: Bacteriolysis productOn 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. | Drug | Panfoshu + conventional treatment group（program-B） |
| Conventional TreatmentPatients in this group were treated with only the conventional treatment. | Other | conventional treatment group |
Primary outcome
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.
2 secondary outcomes
Number of participants with treatment-related adverse events
Time frame: through study completion, an average of 6 months
Types, occurence rate and duration of the treatment-related adverse events
Time frame: through study completion, an average of 6 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Panfoshu+Conventional Treatment（program-A）, Panfoshu+Conventional Treatment（program-B） and Conventional Treatment in people with Otologic Disease, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Therapeutic effective rate (time frame: through study completion, an average of 6 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2023.