Effect of Jing Si Herbal Tea Liquid Packets on Chronic Pharyngolaryngitis: A Randomized, Double-blinded Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Health questionnaire
研究概览
简要总结
Chronic pharyngolaryngitis is common and often make people suffer in many aspects. The etiology is numerous, for example, airway hypersensitivity, gastroesophageal acid regurgitation, sicca syndrome, anxiety, etc.
The investigators aimed to investigate the effect of Jing Si herbal tea liquid packets on chronic pharyngolaryngitis by a design of randomized, double-blind clinical trial in this study. The subjects who were bed-ridden, without self-care ability, receiving hemodialysis, no idea about the details of this study, poor compliance for this study, alcohol and/or drugs additives, pregnancy and breast-feeding women were excluded from this study.
A questionnaire for health and habits was performed at the start of the study, and a questionnaire for Reflux Symptom Index (RSI) was performed at the start and the end of the study. Finally, Student's t-test was used to test the difference between the Jing Si herbal tea group and the control group. And, multivariate linear regression was used to test the violation of clinical factors on the treatment outcome of Jing Si herbal tea liquid packets on chronic pharyngolaryngitis.
详细描述
Chronic pharyngolaryngitis is common and often make people suffer in many aspects. The etiology is numerous, for example, airway hypersensitivity, gastroesophageal acid regurgitation, sicca syndrome, anxiety, etc.
The investigators aimed to investigate the effect of Jing Si herbal tea liquid packets on chronic pharyngolaryngitis by a design of randomized, double-blind clinical trial in this study. One hundred and twenty adults of both sex with a range of age between of 20-70 years old were included. All participants were divided randomly into two groups. Jing Si herbal tea group received 1 pack of Jing Si herbal tea liquid packet twice a day for 1 month (30 days), and the control group received 1 pack of control liquid packet twice a day for 1 month (30 days). The subjects who were bed-ridden, without self-care ability, receiving hemodialysis, no idea about the details of this study, poor compliance for this study, alcohol and/or drugs additives, pregnancy and breast-feeding women were excluded from this study.
A questionnaire for health and habits was performed at the start of the study, and a questionnaire for Reflux Symptom Index (RSI) was performed at the start and the end of the study. Finally, Student's t-test was used to test the difference between the Jing Si herbal tea group and the control group. And, multivariate linear regression was used to test the violation of clinical factors on the treatment outcome of Jing Si herbal tea liquid packets on chronic pharyngolaryngitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult men and women aged 20 to 70 years old.
- •Patients with chronic pharyngitis
排除标准
- •Patients who are bedridden or unable to take care of themselves.
- •Dialysis patients.
- •Patients who cannot understand the details of this study or cannot cooperate with the examination.
- •History of alcohol or drug abuse.
- •Pregnant and lactating women
研究组 & 干预措施
control group
placebo: 2 times a day, 1 sachet each time.
干预措施: control group (Other)
Jing Si herbal tea liquid packets group
Jing Si herbal tea liquid packets: 2 times a day, 1 sachet each time.
干预措施: Jing Si herbal tea liquid packets (Other)
结局指标
主要结局
Health questionnaire
时间窗: Before the test begins and after intervention completed (at 1 month)
the recording items are as follows: age, gender, height, weight, waist circumference, disease history, smoking or not (quantification), drinking or not (quantification), and eating betel nut or not (quantification) , sleeping status, whether to drink coffee (quantification)
Reflux Symptom Index (RSI)
时间窗: Before the test begins and after intervention completed (at 1 month)
The Reflux Symptom Index (RSI) is in common use as a semi-quantitative tool to assess symptoms associated with laryngopharyngeal reflux (LPR). RSI is a scoring tool that consists of nine items used to assess various symptoms associated with LPR. Each item has a scale ranging from zero (no complaints) to five (severe complaints), with a maximum of 45 indicating the most severe symptoms.
次要结局
未报告次要终点