A multi-center, randomized, double-blind, dose exploration, placebo parallel controlled phase II clinical trial to evaluate the efficacy and safety of Yuping Tongqiao Tablets in the treatment of persistent allergic rhinitis (deficiency of lung and spleen)
- Conditions
- Persistent allergic rhinitis
- Registration Number
- ITMCTR2100004325
- Lead Sponsor
- Beijing Hospital of Traditional Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
(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.
(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.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method