allergic rhinitis
Conditions
Interventions
intervention group:probiotic mixture should be taken per os.
control group:placebo should be taken per os.
Sponsors
Shanghai Tongji Hospital
Eligibility
Sex/Gender
All
Age
12 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Subjects must be Chinese citizens aged from 12 to 65 years old, regardless of gender. 2. Subjects must be diagnosed with AR at screening and baseline follow-up (Guidelines for the Diagnosis and Treatment of Allergic Rhinitis, Chinese Journal of Otolaryngology Head and Neck Surgery, 2016,51(01):6-24). 3.AR inclusion criteria: at least 3 of the 4 symptoms of itchy nose, sneezing, runny nose and nasal congestion, and at least 2 symptoms with a score of 2 or more. 4. The subject is in good health and does not suffer from clinically significant diseases that interfere with the schedule or operation of the study or affect the safety of the subject. 5. Subject shall provide written informed consent, subject shall be able to comply with medication and follow-up schedule. 6. Fertile female subjects must have urine HCG negative at the time of screening.
Exclusion criteria
Exclusion criteria: 1. Subjects with acute sinusitis combined with acute nasal infection. 2. Subjects with any clinically abnormal vital signs or clinically significant ECG results at screening or baseline follow-up. 3. Subjects with clinically significant cardiovascular, lung, kidney, liver, metabolic, hematological, or neurological diseases, or with a family history of congenital immunodeficiency or who have taken immunosuppressive or anti-inflammatory therapy for nearly 6 weeks. 4. Subjects who are suffering from an upper respiratory infection. 5. Subjects with deviated septum requiring corrective surgery. 6. Subjects are members of the research team directly involved in this experiment. 7. Patients with nasal diseases such as nasal vestibulitis and nasal tumors. 8. Those who plan to give birth within three months. 9. Participants who have participated in clinical drug trials within three months. 10. Avoid regular probiotics and other dietary nutritional interventions. 11. High alcohol consumption (more than 1 drink per day). 12. Patients known to be allergic to the experimental drug. 13. Have dementia (defined as an MMSE score of 23 or less) or Parkinson's disease or other neurological disorders that cause dysfunction. 14. Patients with a history of autoimmune hepatitis, hepatitis C or haemoglobulinopathies (e.g. Thalassemia major, sickle cell anaemia). 15. Patients with malignant diseases such as malignant tumors and mental diseases. 16. Researchers believe that other reasons should not be included. Use of drugs that may affect the results of the trial, and the withdrawal time is less than the specified time.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| TNSS score of allergic rhinitis symptoms;combined symptom and medication score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Allergic rhinitis ocular symptom TOSS score;visual analogue scale;rhinoconjunctivitis quality of life questionnaire; | — |
Countries
China
Contacts
Public ContactYu shaoqing
Shanghai Tongji Hospital
Outcome results
None listed