Allergy rhinitis
Conditions
Interventions
Treatment group:Biyan No.1 granule+Loratadine placebo
Control group:Loratadine+ Biyan No.1 granule palcebo
Sponsors
Xiamen University
Eligibility
Sex/Gender
All
Age
6 Years to 18 Years
Inclusion criteria
Inclusion criteria: Included patients should meet all of the following criterias (1) Aged 6-18 years; (2) Meet the international diagnostic criteria for AR (ARIA); 1) symptoms: occur two or more of the following symptoms such as sneezing, water-like runny nose, nasal itching and nasal congestion, which lasting or accumulating more than 1 hour a day; 2) signs: nasal mucosa pale, edema, nasal water-like secretions. 3) detection of allergens: at least one allergen was positive for SPT and/or serum specific IgE. (3) Symptom onset >= 4 days/week and >=4 consecutive weeks. (4) The nasal symptom score (TNSS) within 12 hours was at least 8 points, including nasal obstruction score >= 2 points, sneezing or itching score >= 2 points. (5) Patients must suffer from moderate to severe allergy rhinitis, which means the symptoms of rhinitis are relatively serious or severe and has a significant impact on the quality of life (including sleep, daily life, study or work). (6) Patients are knowing, agreeing and volunteered to participate the study and signed the informed consent.
Exclusion criteria
Exclusion criteria: Those with one of the following circumstances will be excluded from this study. (1) Allergic rhinitis with asthma attack, allergic rhinitis with headache and nasal obstruction caused by anatomical factors or other factors (including severe deviation of nasal septum, nasal polyps, sinusitis, etc.) will be excluded from this study; (2) Five-sensory diseases and respiratory diseases (including chronic obstructive pulmonary disease (COPD), emphysema, bronchiectasis, tuberculosis, pneumonia, bronchial asthma, secretory otitis media, etc.) and upper breath Inhalatory tract infection with asthma attack; (3) Postural hypotension, organic heart disease or clinically significant ECG changes; (4) Patients with thyroid disease, diabetes mellitus, hypoglycemia, cardiovascular and cerebrovascular disease, prostatic hypertrophy, glaucoma, epilepsy history, the value of liver function (ALT, AST) as well as renal function (BUN, Cr) was 1.5 times higher than the normal value, hematopoietic dysfunction, gastrointestinal diseases, malignant tumors and other serious diseases that may affect the correct evaluation of curative effect; (5) Patients had a history of mental and neurological diseases; (6) Patients who had received the following treatment before the experiment: immunotherapy within 12 months; long-acting glucocorticoid Injection therapy within 3 months; Asmidazole within 6 weeks; Glucocorticoids for systemic or local use within 1 month (inhalation or nasal spray); Sodium cromoglycerin or Naidomide within 1 month; Long-acting antihistamines within 1 month; Short-acting antihistamines within 1 week; Ketotifen, tricyclic antidepressants, macrolides and antifungal drugs within 2 weeks; Systemic or local nasal decongestants within 24h; using anti-histamine drugs, anticholinergics and antiarrhythmic drugs currently; using barbiturates, antispasmodics, phentolamine and digitalis drugs currently; (7) Patients who are allergic to antihistamine, or patients who are known or suspected to be allergic to research drugs (or similar compounds) or their components; (8) Patients who have participated in other drug clinical trials in the past three months; (9) Abnormal physical examination results with clinical significance before admission, which will affect the achievement of the purpose of this study or hinder the realization of compliance with the research procedures according to the judgement of the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| TNSS; | — |
Secondary
| Measure | Time frame |
|---|---|
| RQLQ;Rescue medication score;IgE;Eosinophil content;IL-4, IL-6,IL-8, IL-10, IL-13, TNF-a;Nasal endoscopy;Detection of intestinal flora;Detection of nasopharyngeal flora; | — |
Countries
China
Contacts
Public ContactZhu Libing
Xiamen University
Outcome results
None listed