NCT02477293已完成4 期
The Efficacy and Safety of Hyeonggaeyeongyo-tang for Chronic Rhinitis According to Pattern Identification in Korean Medicine
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change from baseline in 'Total nasal symptom score (TNSS)'
研究概览
简要总结
The purpose of this study is to evaluate the safety and effectiveness of Hyeonggaeyeongyo-Tang for chronic rhinitis according to pattern identification in Korean medicine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are diagnosed by moderate level of chronic rhinitis for more than 8 weeks
- •At least one of the following conditions: Nasal congestion, rhinorrhea, sneeze, pruritus
- •At least one of the following Moderate abnormality conditions: sleep disturbance; daily activity, physical exercise, leisure activity limitations; work/school work limitations; discomfort with several symptoms
- •Age between 19 and 65 years
- •Able to dialogue
- •Agree with informed consent
排除标准
- •Patients who are taken one of the following drugs for treating rhinitis or acute upper respiratory infections etc
- •Drugs which determined to have negative effect on symptoms of rhinitis or skin prick test (oral or nasal)
- •Short acting anti-histamines / H1 blockers (drug use within lase 1 week)
- •Long acting anti-histamines / H1 blockers (drug use within lase 2 week)
- •Corticosteroids (drug use within lase 1 month) ④ Anti-cholinergic drug (drug use within lase 1 week)
- •Anti-leukotriene drug (drug use within lase 1 week)
- •Decongestants (drug use within lase 1 week) ⑦ Tricyclic antidepressants, phenothiazines (drug use within lase 2 week) ⑧ Non-steroidal analgesics (drug use within lase 1 week) ⑨ Drugs that is judged to be inappropriate for the trial by the researchers
- •Used Korean medicine for treating rhinitis within last 7 days
- •Patients who has severe disease, such as malignant tumor, severe dyslipidemia, liver or kidney dysfunction, anemia, active pulmonary tuberculosis, infection or systemic disease etc
- •Presence of internal nasal obstruction or nasal deformities or history of nasal surgery within 2 months
- •History of active respiratory disease(ex. asthma)
- •Hypertension or Diabetes
- •Experienced immunotherapy or systemic steroid treatments within last 3 months
- •Experienced drug allergic reactions
- •Experienced anaphylactic reactions, during allergen test
- •Female patients who are pregnant or lactating or have the chances of pregnancy
- •Patients who are participated other clinical trials within last 1 month
- •Patients who are unable to participate the trial (paralysis, severe mental or psychological illness, dementia, drug addiction, unable to make to participate in the trial, severe visual or auditory dysfunction, unable to visit hospital regularly, unable to communicate through spoken or written Korean etc)
- •Patients who are judged to be inappropriate for the clinical study by the researchers
研究组 & 干预措施
Hyeonggaeyeongyo-tang
Experimental
干预措施: Hyeonggaeyeongyo-tang (Drug)
结局指标
主要结局
Change from baseline in 'Total nasal symptom score (TNSS)'
时间窗: At baseline, Day 2(Scheduled within a week of baseline), Week 3, 5, 9, 13
Change from baseline in 'pre KiFDA-AR ver 2.0' Questionnaire
时间窗: At baseline, Day 2(Scheduled within a week of baseline), Week 3, 5, 9, 13
次要结局
- Pattern Diagnosis by 'Cold-heat Pattern Identification Questionnaire'(Day 2(Scheduled within a week of baseline))
- Change from baseline in 'Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)'(At baseline, Day 2(Scheduled within a week of baseline), Week 3, 5, 9, 13)
- Pattern diagnosis by doctor of Korean medicine by traditional Korean medicine doctor's four examination(Day 2(Scheduled within a week of baseline))
- Diagnosis of secondary complications of chronic rhinitis (allergic rhinitis) by skin prick test(Day 2(Scheduled within a week of baseline))
- Change from baseline in total immunoglobulin E (IgE)(Day 2(Scheduled within a week of baseline), Week 5)
- Change from baseline in 'Heart Rate Variability'(Day 2(Scheduled within a week of baseline), Week 5)
- Change from Baseline in 'Ryodoraku values'(Day 2(Scheduled within a week of baseline), Week 5)
- Diagnosis of secondary complications of chronic rhinitis (allergic rhinitis and rhino-sinusitis) by Waters, Caldwell, and lateral view (paranasal sinus 3P)(Day 2(Scheduled within a week of baseline))
- Change from baseline in 'Perceived Stress Scale'(Day 2(Scheduled within a week of baseline), Week 5)
- Change from baseline in eosinophil count level(Day 2(Scheduled within a week of baseline), Week 5)
研究者
Minhee Kim
KMD
Kyung Hee University Hospital at Gangdong
研究点 (1)
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