ITMCTR2100004297招募中4 期
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 个研究点开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional study
入排标准
- 年龄范围
- 10 至 60（—）
- 性别
- Male
入选标准
- •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.
排除标准
- •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.
研究者
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