allergic rhinitis
Conditions
Interventions
Exposure group: Biyanitis Oral Liquid or Biyanitis Oral Liquid combined with conventional Western medicine treatment:Use Biyanitis Oral Liquid
Non-exposed group: conventional Western medicine treatment:Do not use Biyanitis Oral Liquid
Sponsors
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
2 Years to 65 Years
Inclusion criteria
Inclusion criteria: This study is divided into two groups based on different ages: Group 1 consists of adolescent and adult patients with allergic rhinitis, and Group 2 consists of children with allergic rhinitis. (1) Group 1: Adolescents and adults with allergic rhinitis 1) Clinically diagnosed with allergic rhinitis, and within 6 months before enrollment, allergy tests indicate that at least one allergen has a positive result in SPT and/or serum-specific IgE, or a positive nasal provocation test; Real-World Study on Biyan Tongqiao Oral Liquid for Allergic Rhinitis Version No.: 1.1 Version Date: 20251202 3 2) Having at least 2 or more nasal symptoms (such as paroxysmal sneezing, clear nasal discharge, nasal itching, and nasal congestion) in the recent week, or the nasal symptoms have worsened to moderate-severe in the recent week; 3) Meeting the TCM syndrome differentiation criteria for Lung Channel Latent Heat Syndrome, and having at least 1 systemic symptom (dry mouth, bitter taste in the mouth, dry stool, red tongue) within 1 week before enrollment; 4) Aged 14-65 years old (=14, =65 years old), regardless of gender; 5) No complicated nasal organic lesions (such as nasal septum deviation, etc.), acute exacerbation of chronic obstructive pulmonary disease, fatal asthma, active pulmonary tuberculosis, or respiratory tract malformations; 6) No severe primary diseases of the heart, liver, lung, kidney, blood and other systems, or severe diseases affecting survival such as malignant tumors. 7) Voluntarily participating in this study and signing the informed consent form. (2) Group 2: Children with allergic rhinitis 1) Clinically diagnosed with allergic rhinitis, and within 6 months before enrollment, allergy tests indicate that at least one allergen has a positive result in SPT and/or serum-specific IgE; 2) Classified as perennial allergic rhinitis according to the type of allergen; 3) Having at least 2 or more nasal symptoms (nasal congestion, clear or viscous nasal discharge, nasal itching, frequent sneezing) in the recent week, or the nasal symptoms have worsened to moderate-severe in the recent week; 4) Meeting the TCM syndrome differentiation criteria for Lung Channel Latent Heat Syndrome, and having at least 1 nasal sign (nosebleed, red nasal mucosa, swollen nasal turbinates, dry nasal cavity) and 1 other systemic symptom (dry mouth, bitter taste in the mouth, dry stool, red tongue) within 1 week before enrollment; 5) Aged 2-13 years old (=2, <14 years old), regardless of gender; 6) No complicated nasal organic lesions (such as nasal septum deviation, etc.), adenoid hypertrophy, the triad of "chronic nasal congestion (including snoring and habitual mouth breathing), nasal discharge and obstructive nasal sound", or fatal asthma, or respiratory tract malformations; 7) Voluntarily participating in this study and the informed consent form is signed by the legal guardian or jointly with the child subject (=8 years old).
Exclusion criteria
Exclusion criteria: NO
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disappearance rate of nasal symptoms at 4 weeks after treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| The change value of the total reactive nasal symptom score (rTNSS) at 2 and 4 weeks after treatment;Changes in the total reactive ocular symptom score (rTOSS) at 2 and 4 weeks after treatment (for pediatric patients only);Time for nasal symptoms to disappear;Effective rates of main symptoms and signs / TCM syndromes at 2 and 4 weeks after treatment (Population 1: nasal itching, sneezing, runny clear nose, itchy throat, dry mouth, cough, red and swollen nasal mucosa, etc.; Population 2: nasal congestion, runny clear or thick nasal discharge, nasal itching, sneezing, nasal bleeding, red nasal mucosa, swollen nasal turbinates, itchy throat, cough, hyposmia, conjunctival congestion, etc.);Disappearance rate of individual TCM symptoms at 2 and 4 weeks after treatment;Changes in the Mini Rhinoconjunctivitis Quality of Life Questionnaire (Mini RQLQ) at 2 and 4 weeks after treatment (for adult patients only);Changes in laboratory test values (such as serum total IgE, serum-specific IgE, etc.) at 2 and 4 weeks after treatment;Incidence rate of acute asthma exacerbations at 2 and 4 weeks after treatment; | — |
Countries
China
Contacts
Public ContactRuan Yan
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Outcome results
None listed