Persistent allergic rhinitis
Conditions
Interventions
test group:Yuping Tongqiao Tablets 4 tablets, 3 times a day, orally
placebo group:Yuping Tongqiao tablet simulant 4 tablets, 3 times a day, orally
Sponsors
Beijing Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged between 18 and 65 (including 18 and 65), regardless of gender; 2. Consistent with the diagnostic criteria of persistent allergic rhinitis (symptom onset >= 4d/ week, and >= consecutive 4 weeks); 3. Comply with TCM syndrome differentiation of lung and spleen deficiency syndrome; 4. At least two of the nasal symptoms of "sneezing, runny nose, stuffy nose, itchy nose" were moderate or severe (score >= 2); 5. Screening stage skin prick test and/or serum-specific IgE antibody detection of at least one perennial allergen (dust mite, cockroach, animal dander, etc.) positive; 6. Volunteer to participate in this clinical trial and sign a written informed consent.
Exclusion criteria
Exclusion criteria: 1. Complicated with severe nasal septum deviation, sinusitis, nasal polyp, hypertrophic rhinitis, and other organic lesions of the nose; 2. Bronchial asthma, cough variant asthma, and other types of asthma; 3. Prior to the screening, patients received allergen immunotherapy or nasal surgery within 6 months; 4. Intranasal or systemic use of corticosteroids, leukotriene modulators, and anti-ige therapy within 30 days prior to screening; Antihistamines and mast cell membrane stabilizers were used within 14 days; He has used anticholinergic drugs, Traditional Chinese medicine, and other non-drug treatments such as acupuncture and acupoint application for AR within 7 days; Treatment with decongestant within 3 days; Or plan to use these drugs or treatments during the study period (excluding emergency devices required for use in this study) due to concomitant medical conditions; 5. Scr of renal function was greater than the upper limit of the reference value or ALT and AST of liver function were more than 1.5 times the upper limit of the reference value; 6. and severe heart, brain, liver, kidney, respiratory system, circulatory system, hematopoietic system, endocrine system, immune system, and other major organ or system serious diseases (such as acute myocardial infarction (mi), malignant tumor, tuberculosis, severe hypertension, diabetes complications such as diabetic ketoacidosis, immunodeficiency diseases such as HIV, such as rheumatoid arthritis, systemic lupus erythematosus (sle) since autoimmune diseases, leukemia, etc.); 7. Women who are pregnant or breast-feeding, or have a birth plan within the next six months, or are unwilling to take effective contraceptive measures during the trial period or within six months after drug withdrawal; 8. Have a history of allergy to the ingredients of the test drug; 9. Large area nasal trauma, severe sodium chloride allergy, or sodium chloride metabolism disorder; 10. Have a long history of alcohol and drug abuse; 11. Have mental retardation or mental disorder; 12. Have participated in clinical trials of other drugs or medical devices within the past 3 months; 13. The researchers think that is not suitable to participate in this clinical trial, according to the researchers to determine the subjects because of physical, cultural level, or work environment often changes (experiments have Beijing on a business trip or living needs), and the possible solution anyway (including a visit planning and diary card or the completion of the questionnaire) compliance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total score for nasal symptoms (TNSS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Nose/eye single symptom score;Total Symptom Score (TOSS);TCM symptom total score and individual symptom score;TCM syndrome curative effect;Rhinoconjunctivitis quality of life questionnaire;Patient Global Impression of Change;Percentage and frequency of use of emergency devices during treatment; | — |
Countries
China
Contacts
Public ContactJunge Wang
Beijing Hospital of Traditional Chinese Medicine
Outcome results
None listed