ITMCTR2100004297
Recruiting
Phase 4
A randomized controlled clinical study evaluating the effectiveness and safety of Tongqiao Biyan Granules in the treatment of moderate to severe persistent allergic rhinitis
Hospital of Chengdu University of Traditional Chinese Medicine0 sitesTBD
ConditionsAllergic rhinitis
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Allergic rhinitis
- Sponsor
- Hospital of Chengdu University of Traditional Chinese Medicine
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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;
Exclusion Criteria
- •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;
Outcomes
Primary Outcomes
Not specified
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