A randomized controlled clinical study evaluating the effectiveness and safety of Tongqiao Biyan Granules in the treatment of moderate to severe persistent allergic rhinitis
- Conditions
- Allergic rhinitis
- Registration Number
- ITMCTR2100004297
- Lead Sponsor
- Hospital of Chengdu University of Traditional Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- Not specified
1. Subjects aged from 10 to 60 years, regardless of gender;
2. For patients with allergic rhinitis, the diagnostic criteria (ARIA) are as follows:
Symptoms: sneezing, clear water like runny nose, itchy nose and stuffy nose appeared 2 or more symptoms, lasting or accumulating for more than 1 hour every day;
Signs: common nasal mucosa pale, edema, nasal water secretion;
Allergen test: at least one allergen SPT and / or serum specific IgE positive
(all results within one year are valid);
3. Patients with lung qi deficiency syndrome, spleen qi deficiency syndrome or lung spleen qi deficiency syndrome;
4. Patients with symptom onset >= 4 days / week, and >= 4 consecutive weeks;
5. Patients with moderate to severe allergic rhinitis have a significant impact on the quality of life (including sleep, daily life, study or work);
6. Patients with nasal symptom score (TNSS) >= 8 within 12 hours, nasal congestion score >= 2;
7. Patients and guardians informed and agreed to participate in the study.
1. Patients with nasal space occupying lesions and structural abnormalities, including but not limited to: nasal polyps, nasal masses, meningeal encephalocele, congenital nostril atresia, congenital piriform foramen stenosis, thickening and internal displacement of maxillary frontal process, deviation of nasal septum, gasification of middle turbinate, etc;
2. Patients with known poor overall physical condition include but are not limited to:
(1) Malignant tumor;
(2) Uncontrolled systemic infection;
(3) Severe malnutrition (BMI < 14);
(4) Poor glycemic control (fasting glucose >= 7.0 mmol / L or 2-hour postprandial glucose >= 11.1 mmol / L after standardized treatment) was found in diabetic patients;
(5) The blood pressure of hypertension patients was poorly controlled (systolic blood pressure >= 160 mmHg and / or diastolic blood pressure >= 100 mmHg after standardized treatment);
(6) Moderate to severe anemia (HB < 90g / L) and / or leukopenia (WBC < 3.5 x 10^9 / L) and / or thrombocytopenia (< 60 x 10^9 / L);
(7) Those who have serious cardiovascular diseases, such as acute myocardial infarction, unstable angina pectoris, chronic heart failure, life-threatening arrhythmias, such as ventricular tachycardia or ventricular fibrillation, and whose ECG abnormalities judged by researchers have clinical significance;
(8) The liver and kidney functions were obviously abnormal: urea nitrogen >= 1.5unl, creatinine >= 1.5unl, AST, ALT >= 1.5unl;
3. Pregnant or lactating women;
4. Subjects who are known or suspected to be allergic to the components of Tongqiao Biyan granules;
5. Subjects with a history of nose or eye injury or surgery in the past three months;
6. Subjects dependent on nasal, oral or ocular decongestants, antihistamines and hormones;
7. Subjects with a history of mental illness (except mild mood disorders);
8. The subjects with dyslexia or communication difficulties can not cooperate to complete the study;
9. Subjects who can't guarantee medication compliance or can't return visit on time;
10. Situations that other researchers believe may seriously affect the research results.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method TNSS;
- Secondary Outcome Measures
Name Time Method AE;IL5;Effective after 3 weeks of treatment;RQLQ;TGF-ß;Anterior rhinoscopy score;TOSS;IL4;