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A multicenter, open, single-arm phase IV clinical trial to evaluate the efficacy and safety of Sanfeng Tongqiao Dropping pills in the treatment of acute rhinitis (exogenous wind chill, stagnation and heat syndrome)

A multicenter, open, single-arm phase IV clinical trial to evaluate the efficacy and safety of Sanfeng Tongqiao Dropping pills in the treatment of acute rhinitis (exogenous wind chill, stagnation and heat syndrome)

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200057768
Enrollment
Unknown
Registered
2022-03-17
Start date
2022-03-17
Completion date
Unknown
Last updated
2023-11-13

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

Conditions

Acute rhinitis

Interventions

Experimental group:Sanfeng Tongqiao dropping pills

Sponsors

The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic criteria of Western medicine for acute rhinitis; 2. In line with the syndrome differentiation standard of TCM external wind and cold syndrome and heat syndrome of lung depression; 3. Aged >18 years, regardless of gender; 4. Acute onset, duration within 48 hours; 5. Participate voluntarily and sign informed consent in person.

Exclusion criteria

Exclusion criteria: 1. Patients who have taken Chinese and Western medicines to treat acute rhinitis after the onset of the disease; 2. Patients suffering from infectious diseases such as influenza, measles, scarlet fever, whooping cough, chickenpox and diphtheria; 3. Patients with allergic rhinitis, vascular active rhinitis, atrophic rhinitis, sinusitis, nasal tumor, and severe deviation of nasal septum; 4. Patients with nasal mucosa dysfunction due to previous nasal surgery, radiotherapy and other reasons; 5. Patients with infectious diseases of the throat or lower respiratory tract requiring the combined use of antibiotics or other drugs with similar effects to the test drugs; 6. Have serious diseases of the heart, lung, liver, kidney or blood system, or serious diseases affecting their survival, such as malignant tumors; 7. Body temperature (axillary temperature) >=37.3?; 8. Abnormal liver and kidney function examination (ALT and AST>= 1.5 times the upper limit of normal value, Cr > the upper limit of normal value); 9. Leukocyte count > 1.2 times the upper limit of normal, neutrophil count > the upper limit of normal, and the investigators judged that bacterial infection of acute rhinitis; 10. Unable to cooperate or unwilling to cooperate because of neurological or mental illness; 11. Suspected or confirmed history of alcohol or drug abuse; 12. Pregnant or lactating patients or those who have recently planned to give birth; 13. Known or suspected allergy to the test drug or its components, or allergic disposition; 14. Participated in or is participating in other clinical trials within the last 3 months; 15. Patients considered unsuitable for this clinical trial by the investigator.

Design outcomes

Primary

MeasureTime frame
Disease response rate after 4 days of administration;

Secondary

MeasureTime frame
Clinical recovery time of disease;Clinical cure rate, significant efficiency and effective rate of TCM syndrome after 4 days of medication;The disappearance time and rate of nasal obstruction, runny nose, sneezing and hypoolfactory after 4 days of medication;Changes of TCM syndrome total score and single symptom score after 4 days of medication;Quantitative changes in anterior nasal examination after 4 days of administration;

Countries

China

Contacts

Public ContactRuan Yan

The First Affiliated Hospital of Guangzhou University of Chinese Medicine

ruanyan63@163.com+86 13925037930

Outcome results

None listed

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