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Efficacy and Safety of Tanreqing Capsule in the Treatment of Influenza Patients With Heat-Toxin Attacking Lung Syndrome: A multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Study

Efficacy and Safety of Tanreqing Capsule in the Treatment of Influenza Patients With Heat-Toxin Attacking Lung Syndrome: A multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400081834
Enrollment
Unknown
Registered
2024-03-13
Start date
2024-03-15
Completion date
Unknown
Last updated
2024-03-18

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

Conditions

Influenza

Interventions

Treatment group:Basic treatment + Tanreqing capsule+ Oseltamivir Phosphate Capsules
Control group:Basic treatment+ Tanreqing capsule placebo+ Oseltamivir Phosphate Capsules

Sponsors

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Age 18~65 years, male or female; 2. The patient had a temperature of 38?, had one or more respiratory symptoms (cough, stuffy nose, sore throat) and one or more systemic symptoms (fatigue, headache, myalgia) within 36 hours before enrollment; had the above influenza clinical manifestations and one or more of the following positive pathogenic test results: ?Influenza virus nucleic acid test is positive; ?Influenza virus antigen test is positive; ?Influenza virus culture isolation is positive; ?The levels of influenza virus-specific IgG antibodies were increased 4 times or higher in both acute and convalescent sera; 3. Meet the diagnostic criteria of Heat-Toxin Attacking Lung Syndrome; 4. Negative pregnancy urine test of female patients; 5. Voluntary treatment, and signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients have received influenza vaccination within 12 months before the study begins; 2. The patient is in the acute phase of chronic diseases, such as blood pressure and blood sugar fluctuates greatly; 3. The patient has an immunodeficiency disease such as AIDS and is receiving systemic steroids or other immunosuppressants; 4. Patients take Chinese herbal medicine or antiviral drugs with similar efficacy to the experimental drugs; 5. Patients have a history of drug and alcohol addiction; 6. Patients were confirmed with COVID-19; 7. Those who do not meet the inclusion criteria, do not take the drugs according to the provisions, and cannot determine the efficacy or incomplete data to affect the efficacy or safety judgment; 8. Participating in other clinical trials within 1 month prior to their inclusion.

Design outcomes

Primary

MeasureTime frame
Time to Fever Resolution;

Secondary

MeasureTime frame
Time of negative reversal of antigen;Time of symptom disappearance (cough, nasal congestion, runny nose, sore throat, fatigue, headache, myalgia);Changes in white blood cells, neutrophils, lymphocytes, monocytes, and C-reactive protein before and after treatment.;

Countries

China

Contacts

Public ContactXu Guihua

Department of Pulmonary Diseases, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

noan9602@163.com+86 135 8563 6986

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026