Clinical trial NCT06520618: Clinical Study on the Efficacy and Safety of Qingre Heji in the Treatment of Acute Upper Respiratory Tract Infection
Official title: Clinical Study on the Efficacy and Safety of Qingre Heji in the Treatment of Acute Upper Respiratory Tract Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Acute Upper Respiratory Tract Infection
Traditional Chinese Medicine
Randomised Controlled Trial
Lead sponsor: Shengjing Hospital
Sponsor class: OTHER
First posted: 2024-07-25
Enrollment: 268
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Overall Symptom and Sign Score Improvement Rate
timeFrame: At days 0 (baseline) and 6
measure: Onset time
timeFrame: At days 0 (baseline) and 6
measure: Antipyretic time
timeFrame: At days 0 (baseline) and 6
measure: Single Symptom and Sign Disappearance Rate
timeFrame: At days 0 (baseline) and 6
Secondary outcomes:
Other outcomes:
Locations:
city: Shenyang
country: China
facility: Shengjing Hospital of China Medical University
state: Liaoning
Study officials:
affiliation: Shengjing Hospital
name: Difei Wang
role: PRINCIPAL_INVESTIGATOR
References: