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临床试验/NCT06520618
NCT06520618已完成1 期

Clinical Study on the Efficacy and Safety of Qingre Heji in the Treatment of Acute Upper Respiratory Tract Infection

Shengjing Hospital1 个研究点 分布在 1 个国家目标入组 268 人开始时间: 2023年2月1日最近更新:
适应症
干预措施
相关药物

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

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

Experimental

干预措施: Qing Re He Ji (Drug)

Control Group

Active Comparator

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

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Li Naijing

Professor

Shengjing Hospital

研究点 (1)

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