Allergic rhinitis
Conditions
Interventions
Qidan Yifei Tongqiao granules:Oral Qidan Yifei Tongqiao granules
placebo-controlled group:oral placebo
Sponsors
Hospital of Chendu University of TCM
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: All participants in this trial study are required to meet the following requirements during the screening visit period (SV/V1) :(1) Any gender, male or non-pregnant/lactating female; (2) Subjects aged between 18-65 years old; (3) Subjects were required to meet the diagnostic criteria for TCM identification of qi deficiency and wind attack with stasis and heat; (4) Meets the diagnostic criteria of Chinese medicine tocriteria for TCM identification of qi deficiency and wind attack with stasis and heat ; (5) Within 12 hours of the subject's Screening Visit (SV/V1), the nasal symptom of "sneezing, runny nose, nasal congestion, nasal itch" has at least 2 items, and nasal congestion = 2 points; (6) Has a terminal allergen (e.g.cockroach, cat dander, dog dander, mold) within 12 months prior to enrollment. " at least 2 items, nasal congestion = 2 points; (6) within 12 months prior to enrollment, there was a positive test for terminal allergens (e.g., dust mites, cockroaches, cat dander, dog dander, molds, etc.); (7) those who were able to independently complete the scales, agreed to and voluntarily participated in the current study, and signed the informed consent form.
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following criteria will be excluded:(1) Pregnant or breastfeeding women, or those who do not wish to use effective contraception during the trial; (2) Comorbid vasomotor rhinitis, drug-induced rhinitis, acute rhinosinusitis, hormonal rhinitis, etc.; (3) Comorbid bronchial asthma, cough-variant asthma, and other types of asthma; (4) Comorbid organic nasal lesions, such as severe deviated septum, chronic rhinosinusitis, nasal polyps, and hypertrophic rhinitis, as evaluated by the investigator at the screening visit (SV/V1) as assessed by the investigator; (5) within 180 days of last treatment with allergen immunization, or within 6 months of nasal surgery, or within 4 weeks of major surgery (as assessed by the investigator) prior to the screening visit (SV/V1); (6) use of sublingual immunization within 180 days prior to the screening visit; and within 120 days of use of an IgE antagonist or any anti-IgE therapy, anti-interleukin-5 therapy; systemic corticosteroid therapy, immunotherapy injections, and immunosuppressive/immunomodulatory medications within 60 days; all intranasal/topical/ocular corticosteroids, inhaled corticosteroids, other investigational abiotic drugs, any known potent CYP3A4 inducer/inhibitor for treatment within 30 days; Within 14 days, treatment with all forms of sodium cromoglycate, nedocromil sodium, lodoxamide, systemic antibiotics, mast cell membrane stabilizers, monoamine oxidase inhibitors, tricyclic antidepressants; within 10 days, treatment with long-acting antihistamines; within 7 days, treatment with OTC cough and cold medicines or sleep aids that contain antihistamines, topical/oral/intranasal decongestants, leukotriene antagonists or arachidonic acid 5-lipoxygenase inhibitors, inhaled/oral/nasal anticholinergics, herbal treatments, and other non-pharmacological treatments that have a therapeutic effect on AR, such as acupuncture, acupressure, etc.; short-acting antihistamines within 5 days; vasoconstrictors within 3 days; sedatives within 3 days; or use of any of the above medications or treatments during the study period due to a comorbid condition; (7) renal function Scr greater than the upper limit of the reference value or liver function ALT/AST > 2.0 times the upper limit of the reference value; (8) During the pilot study, the subject is required to take a medication in combination and the long-term use of this medication will affect the assessment of the effectiveness of the investigational product (as assessed by the investigator), e.g., medications such as tricyclic antidepressants; (9) Varicella/measles vaccine or a history of infection with chicken pox/measles, 21 days prior to screening visit (SV/V1); (10) A history of measles infection; or measles; (10) history of allergy to the components of the test drug; (11) history of allergic skin test reactions and/or other severe local reactions; (12) history of chronic alcohol and drug abuse; (13) including, but not limited to, serious diseases of the major organs or systems, such as the heart, brain, liver, kidneys, respiratory, circulatory, endocrine, immune, and hematopoietic systems, which are combined with severe heart, brain, liver, kidney, respiratory, circulatory, endocrine, immune, and hematopoietic diseases (e.g., acute myocardial infarction, malignant tumor, tuberculosis, severe hypertension, diabetes mellitus, HIV and other immunodeficiency diseases, rheumatoid arthritis, systemic lupus erythematosus and other a
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total Nasal Symptom Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Total ocular symptom score;Nasal sign scores;Traditional Chinese Medicine Syndrome Score Scale;Pittsburgh Sleep Quality Inventory;Hospital Anxiety Depression Scale; | — |
Countries
China
Contacts
Public ContactLi Tian
Hospital of Chendu University of TCM
Outcome results
None listed