The Effectiveness and Safety of Qingyan Lihou Decoction for the Treatment of Chronic Pharyngolaryngitis: A Randomized, Double-blinded, Placebo-controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- The resolution rate of the clinical symptoms of CP
研究概览
简要总结
A randomized, double-blinded, placebo-controlled clinical trial using a Chinese Medicine formula in treating Chronic pharyngolaryngitis. Subjects will be randomized into a treatment group or placebo group for 8 weeks, and then followed by an 8-week post-treatment visit.
详细描述
Chronic pharyngolaryngitis (CP), also known as chronic pharyngitis, is defined as the inflammation of the pharynx, which is at the back of the throat. CP is a common disease characterized by dry throat, sore throat, pharyngeal itching, dry cough, and difficulty in swallowing. In Western medicine, common treatment regimens for CP include lozenges, antibiotics, lasers, and cryotherapy. However, the above treatment modalities may not be effective, and the disease is likely to bounce back repeatedly.
Chinese medicine has been used for the treatment of CP for a long time. Many studies have shown that treatment using Chinese herbal medicine is effective in relieving the symptoms of CP.
This study is to evaluate the efficacy and safety of oral Qingyan Lihou Decoction in relieving the clinical symptoms of patients with CP.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or above (Chinese subjects only);
- •Persistent symptoms of pharyngitis (sore throat, globus, dry throat, dry cough, throat irritation) for more than 3 weeks;
- •Determined to be the following Chinese medicine syndromes by Registered Chinese Medicine Practitioners (RCMPs): Wind-heat invading the upper-jiao, or phlegm heat or Yin deficiency;
- •Visual analog scale (VAS) score for pain ≥ 50 mm;
- •Numeric rating scale (NRS) ≥ 6; and
- •Be able to give voluntary written informed consent.
排除标准
- •Known severe medical conditions, such as cardiovascular, liver or renal dysfunction, diabetes mellitus, cancers, cerebrovascular diseases, blood system diseases;
- •Concomitant use of steroids, nonsteroidal anti-inflammatory drugs (NSAIDs), anticoagulants, and immunotherapy within the past week;
- •Impaired hematological profile and liver / renal function exceed the upper limit of the reference value by 2 times;
- •Known Allergic rhinitis;
- •Known Gastroesophageal Reflux Disease (GERD);
- •Known cancer or suspected cancer of throat/oesophagus;
- •Mechanical obstruction of the throat accountable for the symptoms;
- •Known alcohol and/or drug abuse;
- •Known allergic history to any Chinese herbal medicines; and
- •Subjects who are known pregnant or lactating.
研究组 & 干预措施
Placebo
The placebo medication is composed of starch and an edible pigment and will be matched as closely as possible to the appearance and taste of Qingyan Lihou Decoction granules.
干预措施: Placebo (Other)
Active treatment (Qingyan Lihou Decoction)
It consists of 22 kinds of Chinese medicine as ingredients. It was prepared in granule form.
干预措施: Qingyan Lihou Decoction (Drug)
结局指标
主要结局
The resolution rate of the clinical symptoms of CP
时间窗: 8 weeks
Measure the resolution rate of the clinical symptoms at week 8. According to the "Guiding Principles for Clinical Research of Chinese Medicines", the degree of clinical symptom is divided into 4 grades: asymptomatic, mild symptom, moderate symptom, and severe symptom, with a score of 0\~3.
Improvement of laryngeal signs
时间窗: 8 weeks
Observe the improvement of laryngeal signs via Flexible nasopharyngolaryngoscopy examination
次要结局
- Complete remission rate of Globus symptom(16 weeks)
- Visual analogue scale (VAS) of Globus symptom(8 weeks)
- Change of Numeric rating scale of sore throat(8 weeks)
- Changes of serum level of cytokines(8 weeks)
- Changes of laryngeal hypersensitivity questionnaire (LHQ)(8 weeks)
- Changes of oral microbiome(8 weeks)
- Changes in Sore Throat Assessment Tool-10 (STAT-10)(8 weeks)
- Changes in Eating Assessment Tool-10 (EAT-10)(8 weeks)
- Changes in 36-Item Short Form Survey Instrument (SF-36)(8 weeks)
- Changes of serum level of cytokines(16 weeks)
- Adverse event related to the study treatment(From baseline to week 16)
- Changes in 36-Item Short Form Survey Instrument (SF-36)(16 weeks)
- Complete remission rate of Globus(8 weeks)
- Changes of oral microbiome(16 weeks)
- Visual analogue scale (VAS) of Globus symptom(16 weeks)
- Change of Numeric rating scale of sore throat(16 weeks)
- Changes in Eating Assessment Tool-10 (EAT-10)(16 weeks)
- Changes of laryngeal hypersensitivity questionnaire (LHQ)(16 weeks)
- Changes in Sore Throat Assessment Tool-10 (STAT-10)(16 weeks)
研究者
Prof. Lin Zhixiu
Professor
Chinese University of Hong Kong