Persistent allergic rhinitis
Conditions
Interventions
Experimental drug group:Suxin Tongqiao Granules, 150-200ml boiling water for oral administration, 2 bags per dose, twice daily (once in the morning and once in the evening).
Placebo group:Suxinto Qiao Granules Simulated Agent, 150-200ml boiling water for oral administration, 2 packets per dose, twice daily (once in the morning and once in the evening).
Sponsors
Shanghai City Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Patient age is between 18 and 65 years old, inclusive, with no gender restrictions; (2) Meets the diagnostic criteria for allergic rhinitis, with clinical classification as persistent (symptoms occur =4 days per week, and =4 consecutive weeks); (3) Chinese medical differentiation is diagnosed as wind pathogen invading the lung syndrome; (4) Screening test results for skin prick tests are positive (++ or higher) and/or serum-specific IgE testing shows at least one positive result for perennial inhalant allergens (e.g., dust mites, cockroaches, animal dander, etc.) (measurement value =0.35 kU/L); (Serum-specific IgE testing is preferred and can be added on top of positive skin prick test results); (5) The average TNSS score during the screening and run-in period is =6 points; (6) The patient voluntarily participates in this study and signs a written informed consent form.
Exclusion criteria
Exclusion criteria: (1) Patients who have received allergen-specific immunotherapy; (2) Patients who have undergone any surgery within 4 weeks prior to screening examinations; (3) Patients who have systemically used (for a duration =3 days) systemic glucocorticoids within 4 weeks prior to screening examinations; (4) Patients who have used any drugs with therapeutic effects on allergic rhinitis (such as any formulation of: glucocorticoids, antihistamines, anti-leukotrienes, mast cell membrane stabilizers, decongestants, anticholinergics, etc.; or any traditional Chinese medicine decoctions, Chinese medicine formula granules, Chinese patent medicines, or herbal teas with therapeutic effects on allergic rhinitis) within 1 week prior to screening examinations; (5) Patients with chronic rhinosinusitis, severe deviated nasal septum, asthma, or other severe pulmonary complications (such as pulmonary infections, tuberculosis, etc.); (6) Patients with a history of immunodeficiency diseases (e.g., HIV), cancer, malignant tumors, autoimmune diseases, severe cardiovascular diseases, or other conditions that may significantly reduce life expectancy; (7) Patients with any history of diseases that may affect adherence to the protocol (e.g., severe mental disorders, cognitive impairments, drug abuse, or addiction); (8) Patients with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) =1.5 times the upper limit of the normal reference range at the center, or serum creatinine (Scr) > the upper limit of the normal reference range at the center during screening examinations; (9) Patients with a total white blood cell count (WBC) > the upper limit of the normal reference range at the center during screening examinations; (10) Pregnant women or women planning pregnancy within the next 6 months, or breastfeeding women; (11) Patients with known allergies to any components of the investigational drug used in this study; (12) Patients who have participated in any clinical trial within 3 months prior to screening; (13) Patients deemed unsuitable for participation in this study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in the mean TNSS(?Total Nasal Symptom Score?) value compared to baseline.; | — |
Secondary
| Measure | Time frame |
|---|---|
| The change from baseline in the average value of TNSS(?Total Nasal Symptom Score?) during the entire double-blind treatment period.;The change from baseline in the mean TNSS(?Total Nasal Symptom Score?) values during Week 1, Week 2, and Week 3 of treatment.;The mean change in nasal symptom scores compared to baseline.;Nasal symptom disappearance rate;Duration of disappearance of various nasal symptoms;Traditional Chinese Medicine (TCM) Syndrome Efficacy;The change in the Rhinosinusitis Quality of Life Questionnaire (RQLQ) score from baseline.;Usage rate, number of uses, and amount used of symptomatic supportive therapy;;The average TNSS values and the average scores of nasal symptoms during the entire follow-up period compared to baseline and the entire double-blind treatment period.; | — |
Countries
China
Contacts
Public ContactGuo Yu
Shanghai City Hospital of Traditional Chinese Medicine
Outcome results
None listed