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

NCT06520618 | Completed Phase 1 DMC

• 1 other identifier: M1112
• Study Type: interventional
• Target: 268
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Experimental Group

EXPERIMENTAL

Drug: Qing Re He Ji

Control Group

ACTIVE COMPARATOR

Drug: Shuanghuanglian Oral Liquid

Interventions

Qing Re He Ji DRUG

Oral administration of Qing Re He Ji

Experimental Group

Shuanghuanglian Oral Liquid DRUG

Oral administration of Shuanghuanglian Oral Liquid

Control Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• : Voluntarily sign informed consent
• : Age ≥ 18 years old
• : Meet the diagnostic criteria of acute respiratory tract infection: Internal Medicine edited by chenhaozhu (9th Edition, people's Health Publishing House)

You may not qualify if:

• : Legal infectious diseases with upper respiratory symptoms
• : Patients with severe pneumonia
• : Severe primary diseases such as cardiovascular, cerebrovascular, liver, kidney and hematopoietic system
• : After this episode, he has received other antiviral, anti-inflammatory, antipyretic and analgesic drugs or any other drugs to treat colds
• : Pregnant or lactating women
• : Allergic constitution and drug allergy
• : Psychopath
• : Those who have participated in other clinical trials within three months
• : Persons with a history of drug abuse
• : Other circumstances that the investigator believes are not suitable for enrollment

Sponsors & Collaborators

• Shengjing Hospital: lead

Study Sites (1)

Shengjing Hospital of China Medical University

Shenyang, Liaoning, 110000, China

Location

Study Officials

• Difei Wang

  Shengjing Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 20, 2024
• First Posted: July 25, 2024
• Study Start: February 1, 2023
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: July 25, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)