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NCT Number: NCT06520618

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.

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Key information

Conditions

Acute Upper Respiratory Tract Infection Randomised Controlled Trial Traditional Chinese Medicine

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Shengjing Hospital of China Medical University

Shenyang, Liaoning, 110000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Qing Re He Ji

Drug

Oral administration of Qing Re He Ji

Shuanghuanglian Oral Liquid

Drug

Oral administration of Shuanghuanglian Oral Liquid

Primary outcomes

  1. Overall Symptom and Sign Score Improvement Rate

    Time frame: At days 0 (baseline) and 6

    We use both traditional Chinese medicine (TCM) and Western medicine scales to assess the condition.

  2. Onset time

    Time frame: At days 0 (baseline) and 6

    Defined as the duration from medication administration to a 0.5°C decrease in body temperature.

  3. Antipyretic time

    Time frame: 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

  4. Single Symptom and Sign Disappearance Rate

    Time frame: At days 0 (baseline) and 6

    Disappearance rate of individual TCM symptoms and signs

Sponsors and collaborators

Lead sponsor

Shengjing Hospital

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 25, 2024
Registry last updated
Jul 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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