NCT03009136Unknown3 期
Efficacy and Safety of So-Cheong-Ryong-Tang on Perennial Allergic Rhinitis: Study Protocol for a Double-blind, Randomized, Parallel-group, Multi-center Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 154
- 试验地点
- 1
- 主要终点
- Change from baseline in Total Nasal Symptom score
研究概览
简要总结
The aim of this study is to investigate the short and long term efficacy and the safety of SCRT treatment for PAR
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18-60 years
- •presence of two or more nasal symptoms (rhinorrhea, nasal congestion, nasal itching and sneezing) with severity score ≥ 2 (0 = no symptom, 1 = mild symptom, 2 = moderate symptom, and 3=severe symptom)
- •presence of nasal symptoms more than 2 consecutive years; and
- •positive reaction to the one or more perennial allergen in skin prick test.
排除标准
- •treatment with nasal/oral corticosteroids within the past month; nasal cromolyn or tricyclic antidepressants within the past two weeks; or nasal/oral decongestants, nasal/oral antihistamines, or antileukotrienes within the past week
- •presence of rhinosinusitis (paranasal sinus X-ray demonstrating mucosal thickening, or partial or complete opacification of the paranasal sinuses)
- •presence of hypertension (systolic ≥ 180 mmHg or diastolic ≥ 100 mmHg)
- •presence of abnormal liver function (aspartate transaminase (AST) or alanine transaminase (ALT) ≥ 100 IU/L) or abnormal renal function (blood urea nitrogen (BUN) ≥ 30 mg/dL or creatinine ≥ 1.8 mg/dL (male), 1.5 mg/dL (female))
- •presence of neoplasm, severe systemic inflammation, other systemic disease that affects rhinitis
- •history of drug allergy
- •history of anaphylaxis for allergic tests
- •pregnancy or lactation
- •participation of other clinical study within the past 3 months.
研究组 & 干预措施
SCRT group
Experimental
3g, three times a day, each taken before or between meals
干预措施: SCRT (Drug)
placebo group
Placebo Comparator
3g, three times a day, each taken before or between meals
干预措施: Placebos (Drug)
结局指标
主要结局
Change from baseline in Total Nasal Symptom score
时间窗: At baseline, week 2, 4, 8, 12
次要结局
- Change from baseline in eosinophil count(At baseline, week 4)
- Change from baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score(At baseline, week 2, 4, 8, 12)
- Change from baseline in Total serum IgE level(At baseline, week 4)
- Change from baseline in cytokine level(At baseline, week 4)
研究者
Minhee Kim
Clinical Professor
Kyung Hee University Hospital at Gangdong
研究点 (1)
Loading locations...
相似试验
撤回
不适用
Long-Term Follow-up of the Safety and Efficacy of RCT-01 in Men and Women With Unilateral, Chronic Achilles TendinosisTendinosisTendinopathyNCT02655042RepliCel Life Sciences, Inc.
招募中
不适用
The efficacy and safety of So-Cheong-Ryong-Tang for perennial allergic rhinitisKCT0002225Kyung Hee University154
已完成
3 期
A Study to Assess Efficacy, Long Term Safety and Tolerability of RT001 in Subjects With Friedreich's AtaxiaFriedreich's AtaxiaNCT04102501Retrotope, Inc.65
已完成
3 期
Effect of Socheongryong-tang and Yeongyopaedok-san in Upper Respiratory Tract InfectionUpper Respiratory Tract InfectionsNCT01019889Korea Health Industry Development Institute480
已完成
4 期
The Efficacy and Safety of Hyeonggaeyeongyo-tang for Chronic Rhinitis According to Pattern Identification in Korean MedicineRespiratory Tract DiseasesNose DiseasesRhinitisNCT02477293Kyung Hee University Hospital at Gangdong40