Chia Yi Chang Gung Memorial Hospital
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- WHOQOL-brief score (Taiwan version)
研究概览
简要总结
This study investigate the nasal irrigation with Traditional herbal medicine extract-saline isotonic solution in the treatment of chronic rhinitis and sinusitis. Half of participants will receive Traditional herbal medicine extract-saline isotonic solution nasal irrigation, while the other half will receive saline alone nasal irrigation.
详细描述
In the program, the investigators plan to investigate a clinical triad to research the outcomes of nasal irrigation with Traditional herbal medicine extract-saline isotonic solution for treatment of chronic rhinitis and sinusitis. The aims of this study are listed below:
Aim 1: evaluating the outcomes and quality of life of nasal irrigation with Traditional herbal medicine extract-saline isotonic solution to treat enrolled patients with chronic rhinitis or sinusitis. The investigators use modern devices to evaluate the autonomic nerve, meridian energy and pulse. The questionnaires of quality of life and symptoms will be recorded. Nasal irrigation with saline alone will be conducted during the clinical triad to compare the effectiveness and quality of life with Traditional herbal medicine extract.
Aim 2: analyzing the changes of bacteria culture in nasal discharge collected during the clinical triad before and after nasal irrigation for investigating the microenvironment of Traditional herbal medicine extract-saline isotonic solution.
According to the research, the investigators will realize the improvement of using Traditional herbal medicine extract-saline isotonic solution for nasal irrigation to treat sino-nasal diseases, by investigating the changes of quality of life and microenvironment of nasal cavity. The nasopharyngoscopic examination, autonomic nerve, meridian energy and pulse were record to compare the effectiveness of Traditional herbal medicine extract-saline isotonic solution with nasal irrigation with saline alone.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnostic criteria for chronic rhinitis and sinusitis male and female volunteers.
- •Stop using oral and topical steroid and anti-histamine treatments >2 weeks prior to enrollment.
- •>20 years of age.
排除标准
- •Allergy to herbal medicine.
- •Presence of a sinus tumor.
- •Significant immune dysfunction.
- •Pregnancy and breast-feeding women.
- •Undergone nasal surgery <1 week prior to enrollment.
结局指标
主要结局
WHOQOL-brief score (Taiwan version)
时间窗: one month
consisting of 28 items, each scored from 1 to 5; total score recorded as the sum of all items change from baseline: the questionnaires of quality of life
次要结局
- 22-item Sino-Nasal Outcome Test score (SNOT-22)(one month)
- Posttreatment culture negativity(one month)
- Nasopharyngoscopic examination change(one month)
- Total symptom score(TSS）(one month)
- Autonomic nerve (HRV)(one month)
- Meridian energy(one month)