rhinallergosis
Conditions
Interventions
control group:Suxin Tongqiao Particle Simulator take 150-200ml of boiling water orally 2 bags at a time twice a day (once in the morning and once in the evening).
Experimental group:Suxin Tongqiao Granules taken with 150-200ml of boiling water 2 bags at a time 2 times a day (once in the morning and once in the evening)
Sponsors
Shanghai Municipal Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) 18 years old = Patient age = 65 years old gender not limited; (2) Meets the diagnostic criteria for allergic rhinitis clinically classified as persistent (symptom onset = 4 days/week and = 4 consecutive weeks); (3) Traditional Chinese medicine syndrome differentiation is wind pathogenic invasion of the lungs syndrome; (4) Screening and examination of skin prick test results positive (++or above) and/or serum specific IgE testing positive for at least one perennial inhaled allergen (dust mites cockroaches animal dander etc.) Sex (measured value = 0.35kU/L); (Serum specific IgE testing is preferred and can be imported based on a positive skin prick test result) (5) The average TNSS score of patients during screening and screening/import 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 the past 4 weeks prior to screening examination; (3) Select patients who have received systemic corticosteroid or anti IgE therapy (with a treatment duration of = 3 days) within the 4 weeks prior to the screening examination; (4) Any medication or treatment that has therapeutic effects on allergic rhinitis (such as glucocorticoids antihistamines leukotrienes mast cells) used within the week prior to screening examination Membrane stabilizers decongestants anticholinergic drugs etc; Or any substance with therapeutic effects on allergic rhinitis Chinese herbal pieces Chinese herbal formula granules traditional Chinese patent medicines and simple preparations herbal tea etc; Or any treatment for allergies Patients with rhinitis such as acupuncture and moxibustion cupping acupoint application etc.); (5) Patients with chronic rhinosinusitis severe nasal septum deviation bronchial asthma or other serious pulmonary complications (such as pulmonary infections tuberculosis etc.); (6) History of immunodeficiency diseases (such as HIV) cancer malignant tumors autoimmune diseases serious cardiovascular or cerebrovascular diseases or other diseases that may significantly reduce life expectancy; (7) History of any illness that may affect adherence to the protocol (such as severe mental disorders cognitive impairment drug abuse or addiction etc.); (8) Screening and examination of serum specific IgE detection showed a seasonal positive result for inhaled allergens (pollen fungi etc.) (measurement value = 0.35kU/L); (9) Screening and examination of patients with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) = 1.5 times the upper limit of the reference value in our center or blood creatinine (Scr)>the reference value in our center Upper limit of exam scores; (10) Screening tests show that the total white blood cell count (WBC) in the patient's blood routine is greater than the upper limit of the reference value in our center; (11) For TNSS records with a screening/import period of less than 4 days; (12) Pregnant or lactating women who are preparing for pregnancy within six months; (13) Individuals who are known to be allergic to the ingredients in the medication used in this study; (14) Individuals who have participated in any clinical trials within the past 3 months prior to screening and examination; (15) Researchers determine that patients who are not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in TNSS mean value from baseline in the fourth week of medication; | — |
Secondary
| Measure | Time frame |
|---|---|
| Symptomatic supportive treatment usage rate, frequency of use, and dosage;Efficacy of Traditional Chinese Medicine Symptoms after 2 and 4 Weeks of Medication;Changes in the average TNSS and nasal symptom scores during the entire follow-up period compared to baseline and the entire double-blind treatment period;The disappearance rate of nasal symptoms after 4 weeks of medication;The average changes in nasal symptom scores from baseline in the first, second, third, and fourth weeks of medication;The change in the average TNSS value compared to baseline during the entire double-blind treatment period;Changes in TNSS mean values from baseline in the first, second, and third weeks of medication;Time for disappearance of nasal symptoms after medication;Changes in Quality of Life Questionnaire (RQLQ) scores for Rhinoconjunctivitis after 2 and 4 weeks of medication compared to baseline; | — |
Countries
China
Contacts
Public ContactGuo Yu
Shanghai Municipal Hospital of Traditional Chinese Medicine
Outcome results
None listed