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

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.

Study Overview

• Status: Completed
• Conditions: Traditional Chinese Medicine; Acute Upper Respiratory Tract Infection; Randomised Controlled Trial
• Intervention / Treatment: Drug: Qing Re He Ji; Drug: Shuanghuanglian Oral Liquid

• Study Type: Interventional
• Enrollment (Actual): 268
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Liaoning
    • Shenyang, Liaoning, China, 110000
      • Shengjing Hospital Of China Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group	Drug: Qing Re He Ji; Oral administration of Qing Re He Ji
Active Comparator: Control Group	Drug: Shuanghuanglian Oral Liquid; Oral administration of Shuanghuanglian Oral Liquid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Symptom and Sign Score Improvement Rate	We use both traditional Chinese medicine (TCM) and Western medicine scales to assess the condition.	At days 0 (baseline) and 6
Onset time	Defined as the duration from medication administration to a 0.5°C decrease in body temperature.	At days 0 (baseline) and 6
Antipyretic time	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	At days 0 (baseline) and 6
Single Symptom and Sign Disappearance Rate	Disappearance rate of individual TCM symptoms and signs	At days 0 (baseline) and 6

Collaborators and Investigators

• Sponsor: Shengjing Hospital
• Investigators: Principal Investigator: Difei Wang, Shengjing Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Actual): February 1, 2024
• Study Completion (Actual): February 1, 2024

Study Registration Dates

• First Submitted: July 20, 2024
• First Submitted That Met QC Criteria: July 20, 2024
• First Posted (Actual): July 25, 2024

Study Record Updates

• Last Update Posted (Actual): July 25, 2024
• Last Update Submitted That Met QC Criteria: July 20, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Infections; Communicable Diseases; Respiratory Tract Infections
• Other Study ID Numbers: M1112

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: One years after the article was published, disclose the original data if necessary.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No