Clinical Study on the Efficacy and Safety of Qingre Heji in the Treatment of Acute Upper Respiratory Tract Infection
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 268
- 试验地点
- 1
- 主要终点
- Antipyretic time
研究概览
简要总结
Originating from China, TCM complements conventional approaches by alleviating symptoms, balancing physical conditions, and enhancing immunity. Clinical studies have shown TCM to be safe and effective in treating AURI. In TCM syndrome differentiation, AURI is considered a "Wind-Heat Syndrome", requiring treatment that clears heat and detoxifies the body. Qing Re He Ji (QRHJ; heat-clearing mixture), a TCM compound developed by our hospital, comprises Huang Qin (Radix Scutellariae), Da Qing Ye (Folium Isatidis), Ge Gen (Radix Puerariae), Yin Chen (Herba Artemisiae Scopariae), and Guan Zhong (Cyrtomium Rhizome). Widely used for AURI, QRHJ effectively clears heat, eliminates pathogens, and strengthens healthy qi. Clinical applications have demonstrated its efficacy, complemented by significant advancements in animal experiments and pharmacokinetics research. To further validate these results, systematic clinical research is imperative, especially in the context of limited direct comparisons between QRHJ and other commercially available TCMs like Shuang Huang Lian (SHL) oral liquid, known for its efficacy and safety in AURI treatment.
Therefore, we performed a rigorously designed non-inferiority randomised controlled trial to assess the efficacy and safety of QRHJ in treating AURI in adults, comparing it directly with SHL oral liquid. This study aimed to bridge existing research gaps and provide healthcare professionals with more diversified treatment options, thereby enhancing personalised and comprehensive patient care plans. Furthermore, we hope that our findings will establish a scientific basis for integrating TCM into modern healthcare practices, promoting the synergy of Chinese and Western medicine.
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1: Voluntarily sign informed consent
- •2: Age ≥ 18 years old
- •3: Meet the diagnostic criteria of acute respiratory tract infection: Internal Medicine edited by chenhaozhu (9th Edition, people's Health Publishing House)
排除标准
- •1: Legal infectious diseases with upper respiratory symptoms
- •2: Patients with severe pneumonia
- •3: Severe primary diseases such as cardiovascular, cerebrovascular, liver, kidney and hematopoietic system
- •4: After this episode, he has received other antiviral, anti-inflammatory, antipyretic and analgesic drugs or any other drugs to treat colds
- •5: Pregnant or lactating women
- •6: Allergic constitution and drug allergy
- •7: Psychopath
- •8: Those who have participated in other clinical trials within three months
- •9: Persons with a history of drug abuse
- •10: Other circumstances that the investigator believes are not suitable for enrollment
研究组 & 干预措施
Experimental Group
干预措施: Qing Re He Ji (Drug)
Control Group
干预措施: Shuanghuanglian Oral Liquid (Drug)
结局指标
主要结局
Antipyretic time
时间窗: At days 0 (baseline) and 6
Measured as the time taken for axillary temperature to drop below 37.3°C after the first dose and maintained for at least 24 hours without recurrence
Single Symptom and Sign Disappearance Rate
时间窗: At days 0 (baseline) and 6
Disappearance rate of individual TCM symptoms and signs
Overall Symptom and Sign Score Improvement Rate
时间窗: At days 0 (baseline) and 6
We use both traditional Chinese medicine (TCM) and Western medicine scales to assess the condition.
Onset time
时间窗: At days 0 (baseline) and 6
Defined as the duration from medication administration to a 0.5°C decrease in body temperature.
次要结局
未报告次要终点
