Ignite Creation Date:
2025-12-25 @ 4:41 AM
Ignite Modification Date:
2026-01-20 @ 3:47 PM
Study NCT ID:
NCT06520618
Status:
COMPLETED
Last Update Posted:
2024-07-25
First Post:
2024-07-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Study on the Efficacy and Safety of Qingre Heji in the Treatment of Acute Upper Respiratory Tract Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 268}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-20', 'studyFirstSubmitDate': '2024-07-20', 'studyFirstSubmitQcDate': '2024-07-20', 'lastUpdatePostDateStruct': {'date': '2024-07-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Symptom and Sign Score Improvement Rate', 'timeFrame': 'At days 0 (baseline) and 6', 'description': 'We use both traditional Chinese medicine (TCM) and Western medicine scales to assess the condition.'}, {'measure': 'Onset time', 'timeFrame': 'At days 0 (baseline) and 6', 'description': 'Defined as the duration from medication administration to a 0.5°C decrease in body temperature.'}, {'measure': 'Antipyretic time', 'timeFrame': 'At days 0 (baseline) and 6', 'description': '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'}, {'measure': 'Single Symptom and Sign Disappearance Rate', 'timeFrame': 'At days 0 (baseline) and 6', 'description': 'Disappearance rate of individual TCM symptoms and signs'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Upper Respiratory Tract Infection', 'Traditional Chinese Medicine', 'Randomised Controlled Trial']}, 'descriptionModule': {'briefSummary': '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.\n\nTherefore, 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 1: Voluntarily sign informed consent\n\n 2: Age ≥ 18 years old\n\n 3: Meet the diagnostic criteria of acute respiratory tract infection: Internal Medicine edited by chenhaozhu (9th Edition, people's Health Publishing House)\n\nExclusion Criteria:\n\n* 1: Legal infectious diseases with upper respiratory symptoms\n\n 2: Patients with severe pneumonia\n\n 3: Severe primary diseases such as cardiovascular, cerebrovascular, liver, kidney and hematopoietic system\n\n 4: After this episode, he has received other antiviral, anti-inflammatory, antipyretic and analgesic drugs or any other drugs to treat colds\n\n 5: Pregnant or lactating women\n\n 6: Allergic constitution and drug allergy\n\n 7: Psychopath\n\n 8: Those who have participated in other clinical trials within three months\n\n 9: Persons with a history of drug abuse\n\n 10: Other circumstances that the investigator believes are not suitable for enrollment"}, 'identificationModule': {'nctId': 'NCT06520618', 'briefTitle': 'Clinical Study on the Efficacy and Safety of Qingre Heji in the Treatment of Acute Upper Respiratory Tract Infection', 'organization': {'class': 'OTHER', 'fullName': 'Shengjing Hospital'}, 'officialTitle': 'Clinical Study on the Efficacy and Safety of Qingre Heji in the Treatment of Acute Upper Respiratory Tract Infection', 'orgStudyIdInfo': {'id': 'M1112'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental Group', 'interventionNames': ['Drug: Qing Re He Ji']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'interventionNames': ['Drug: Shuanghuanglian Oral Liquid']}], 'interventions': [{'name': 'Qing Re He Ji', 'type': 'DRUG', 'description': 'Oral administration of Qing Re He Ji', 'armGroupLabels': ['Experimental Group']}, {'name': 'Shuanghuanglian Oral Liquid', 'type': 'DRUG', 'description': 'Oral administration of Shuanghuanglian Oral Liquid', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110000', 'city': 'Shenyang', 'state': 'Liaoning', 'country': 'China', 'facility': 'Shengjing Hospital of China Medical University', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}], 'overallOfficials': [{'name': 'Difei Wang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shengjing Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'One years after the article was published, disclose the original data if necessary.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shengjing Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Li Naijing', 'investigatorAffiliation': 'Shengjing Hospital'}}}}