Persistent allergic rhinitis
Conditions
Interventions
Low dose group:Take 4 tablets three times a day
The placebo group:Take 6 tablets three times a day
High dose group:Take 6 tablets three times a day
Sponsors
Beijing Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Meet the diagnostic criteria for persistent allergic rhinitis; (2) At least 2 of the nasal symptoms "sneezing, runny nose, nasal congestion, nasal itching" are moderate or severe (score >= 2 points); (3) Comply with TCM syndrome differentiation of lung and spleen deficiency syndrome; (4) Age from 18 to 65 years old (including 18 and 65 years old), male or female; (5) Volunteer to participate in this clinical trial and sign a written informed consent.
Exclusion criteria
Exclusion criteria: (1) Subjects with severe nasal septum deviation, sinusitis, nasal polyps, hypertrophic rhinitis and other organic nasal diseases; (2) Subjects with various types of asthma such as bronchial asthma and cough variant asthma; (3) Received allergen immunotherapy before enrollment or received nasal surgery within 6 months before enrollment; (4) Received intranasal or systemic corticosteroids, leukotriene regulators, and immunotherapy within 30 days before enrollment; received antihistamines, mast cell membrane stabilizers within 14 days; received anticholinergics, Chinese medicine within 7 days and other non-drug treatments that have therapeutic effects on AR, such as acupuncture and acupoint application; received decongestants within 3 days; or plan to receive the above-mentioned drugs or treatments during the study due to comorbid diseases; (Excluding emergency devices used in this study); (5) Scr is greater than the upper limit of the reference value or ALT, AST > 1.5 times the upper limit of the reference value; (6) Subjects who have any of the following documented conditions: Severe diseases) of major organs or systems such as the heart, brain, liver, kidney, respiratory system, circulatory system, endocrine system, immune system, hematopoietic system, etc. (such as acute myocardial infarction, malignant tumors, tuberculosis, severe hypertension Diabetic ketoacidosis and other diabetes comorbidities, HIV and other immunodeficiency diseases, rheumatoid arthritis, systemic lupus erythematosus and other autoimmune diseases, leukemia, etc.); (7) Pregnant or lactating women, or have a childbirth plan in the next six months, or are unwilling to take effective contraceptive measures during the trial period or within six months after stopping the drug; (8) A history of allergy to components of study medication; (9) Large area trauma to the nasal cavity, or severe sodium chloride allergy or sodium chloride metabolism disorder; (10) A long-term history of alcohol and drug abuse; (11) There is an intellectual or mental disorder; (12) Participated in clinical trials of other drugs or medical devices in the past 3 months; (13) The investigator believes that the subject is not suitable to participate in this clinical trial. in the opinion of the investigator, the subject's compliance with the protocol (including visit plan, diary card or questionnaire) may be affected by the subject's physical, cultural level or frequent changes in the work environment.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| TCM syndrome curative effect;Quality of life score;Total score for nasal symptoms (TNSS);Total Symptom Score (TOSS);TCM symptom total score and individual symptom score;Nose/eye single symptom score;Clinical efficacy of nasal symptoms and onset time of drugs; | — |
Countries
China
Contacts
Public ContactWang Junge
Beijing Hospital of Traditional Chinese Medicine
Outcome results
None listed