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

NCT ID: NCT06520618

Last Updated: 2024-07-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 268 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-01
• Study Completion Date: 2024-02-01

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.

Conditions

Acute Upper Respiratory Tract Infection; Traditional Chinese Medicine; Randomised Controlled Trial

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Experimental Group

Group Type: EXPERIMENTAL

Qing Re He Ji

Intervention Type: DRUG

Oral administration of Qing Re He Ji

Control Group

Group Type: ACTIVE_COMPARATOR

Shuanghuanglian Oral Liquid

Intervention Type: DRUG

Oral administration of Shuanghuanglian Oral Liquid

Interventions

Qing Re He Ji

Oral administration of Qing Re He Ji

Intervention Type: DRUG

Shuanghuanglian Oral Liquid

Oral administration of Shuanghuanglian Oral Liquid

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shengjing Hospital

OTHER

Sponsor Role: lead

Responsible Party

Li Naijing

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Difei Wang

Role: PRINCIPAL_INVESTIGATOR

Shengjing Hospital

Locations

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China

Countries

China

Other Identifiers

M1112

Identifier Type: -

Identifier Source: org_study_id