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

NCT06520618 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 268

Last updated 2024-07-25

No results posted yet for this study

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

Interventions

DRUG

Qing Re He Ji

Oral administration of Qing Re He Ji

DRUG

Shuanghuanglian Oral Liquid

Oral administration of Shuanghuanglian Oral Liquid

Sponsors & Collaborators

  • Shengjing Hospital

    lead OTHER

Principal Investigators

  • Difei Wang · Shengjing Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-01
Primary Completion
2024-02-01
Completion
2024-02-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06520618 on ClinicalTrials.gov