Allergic Rhinitis
Conditions
Interventions
experimental group:Oral Peifeikang capsules, 2 times per day, 4 tablets per day
control group:Take a placebo orally, 2 times per day, 4 tablets per daypills twice a day
Sponsors
Tongji Hospital affiliated to Tongji University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. The subjects must be Chinese citizens aged from 18 to 65 years; 2. Subjects must be diagnosed with AR during screening and baseline follow-up; 3. AR criteria for inclusion: Having at least 3 of 4 symptoms of nasal itching, sneezing, runny nose and nasal obstruction, and having a score of 2 or above for at least 2 symptoms; 4. The subjects were in good health and did not suffer from clinically significant diseases that interfered with the trial schedule or operation or affected the safety of the subjects; 5. The subject provides written informed consent and must be able to adhere to medication and follow-up schedules; 6. In fertile female subjects, urine HCG must be negative at screening.
Exclusion criteria
Exclusion criteria: 1. Subjects with acute sinusitis and acute infection of the nasal cavity; 2. Subjects whose vital signs were clinically abnormal or whose ECG results were clinically abnormal at screening or baseline follow-up; 3. Subjects with clinically significant cardiovascular, pulmonary, renal, liver, metabolic, hematologic or neurological disorders, or a family history of congenital immunodeficiency, or nearly 6 weeks of immunosuppressive or anti inflammatory therapy; 4. Subjects with upper respiratory tract infections; 5. Subjects with deviated Septum who needed corrective surgery; 6. The subjects were members of the research team directly involved in the study; 7. With nasal vestibulitis, nasal tumor and other nasal diseases; 8. Planned parenthood within three months; 9. Participated in a clinical drug trial within 3 months; 10. Avoid regular consumption of probiotics and other dietary and nutritional interventions; 11. High alcohol consumption (more than 1 glass of wine per day); 12. Patients known to be allergic to the experimental drug; 13. Patients with dementia (defined as a MMSE score <=23) or Parkinsons disease or other functional disorders; 14. Patients with a history of autoimmune hepatitis, Hepatitis C or haemoglobin disorders (such as severe thalassemia, sickle cell anemia); 15. Patients with malignant tumors, mental disorders and other malignant diseases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Allergic Rhinitis Symptom TNSS and TOSS score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Visual analogue scale;rhinoconjunctivitis quality of life questionnaire;combined symptom and medication score;combined symptom and medication score;Immune Index;Detection of Intestinal Flora diversity; | — |
Countries
China
Contacts
Public ContactYu Shaoqing
Tongji Hospital affiliated to Tongji University
Outcome results
None listed