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A Multicenter Open-Label Randomized Controlled Clinical Study of kanggan Mixture on the Treatment of Influenza

A Multicenter Open-Label Randomized Controlled Clinical Study of Kanggan Mixture on the Treatment of Influenza

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000743
Enrollment
Unknown
Registered
2025-04-14
Start date
2025-05-01
Completion date
Unknown
Last updated
2025-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza

Interventions

intervention group:Kanggan mixture

Sponsors

Jiangsu Provincial Hospital of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patients who meet the diagnostic criteria for influenza and the traditional Chinese medicine diagnostic criteria for Wind-Heat invading the Lung-Wei; 2. Aged between 18 and 65 years regardless of gender; 3. Within 48 hours of onset of illness; 4. Capable of completing ?all study-related assessments?; 5. Informed consent voluntary participation.The informed consent process should adhere to GCP guidelines.

Exclusion criteria

Exclusion criteria: 1. Participants who have received antiviral treatment for influenza infection for more than 48 hours before screening; 2. Participants with known severe renal impairment or those undergoing continuous renal replacement therapy hemodialysis or peritoneal dialysis; 3. Participants with mental changes or convulsions (such as slow response somnolence and restlessness); 4. Participants with severe gastrointestinal symptoms (such as severe nausea vomiting diarrhea and even dehydration); 5. Participants with any of the following critical illnesses: respiratory failure acute necrotizing encephalopathy infectious shock multiple organ dysfunction or other serious clinical conditions requiring intensive care; 6. Participants with tuberculosis measles HIV/AIDS or other infectious diseases; 7. Pregnant women (including those with a positive pregnancy test at enrollment) breastfeeding women or women within 2 weeks postpartum; 8. Participants determined by the investigator to have a history of allergy or severe intolerance to oseltamivir and herbal medicines; 9. Participants who are currently involved in or have participated in another influenza treatment trial within the past 28 days; 10. Patients deemed by the investigator as unlikely to comply with study visits self-assessment and interventions. 11.The blood test shows a significant increase in neutrophils, suggesting bacterial infectious bronchitis in the patient.

Design outcomes

Primary

MeasureTime frame
Time to disease remission;

Secondary

MeasureTime frame
Total Influenza Symptom Score;Time to antipyretic effect onset;Changes in Viral Load in Nasopharyngeal Secretions;Changes in Traditional Chinese Medicine (TCM) Syndrome Score from Baseline;Single-item influenza symptom score;

Countries

China

Contacts

Public ContactHe Hailang

Affiliated Hospital of Nanjing University of Chinese Medicine

lyghehailang@163.com15951950807

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Jun 4, 2026