Efficacy and safety of honeysuckle oral liquid in the treatment of novel coronavirus pneumonia (COVID-19): a multicenter, randomized, controlled, open clinical trial

Phase 4

Recruiting

• Conditions: ovel Coronavirus Pneumonia (COVID-19)

• Registration Number: ITMCTR2000003132
• Lead Sponsor: Hubei Hospital of Traditional Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Diagnosed Novel coronavirus pneumonia patients or clinically diagnosed NCP patients in Hubei Province;
2. Aged 18 to 65 years;
3. The time interval between symptom onset and randomization was within 7 days (the onset of symptom was mainly determined by the time of fever);
4. Sign the written informed consent before the study.

Exclusion Criteria

1. There is clear evidence of bacterial infection in respiratory tract infection caused by basic diseases such as primary immunodeficiency disease, congenital respiratory tract malformation, congenital heart disease, gastroesophageal reflux disease and pulmonary dysplasia;
2. Subjects with the following conditions: asthma requiring daily treatment, any other chronic respiratory disease, respiratory system bacterial infection such as suppurative tonsillitis, acute bronchitis, sinusitis, otitis media or other respiratory diseases affecting the evaluation of clinical trials. Or with Chest CT confirmed the presence of serious interstitial lung disease, bronchiectasis and other basic lung diseases;
3. critically ill patients based on the New Protocol for Diagnosis and Treatment of NCP;
4. Severe liver disease (such as child Pugh score >=C, AST > 5 ULN);
5. Patients with severe renal insufficiency (estimated glomerular filtration rate <=30ml/min/1.73m2) or continuous renal replacement therapy, hemodialysis or peritoneal dialysis;
6. Pregnant or breast-feeding women;
7. Patients may be transferred to non-designated hospitals within 72 hours;
8. Patients who have participated in other clinical trials in the past 7 days;
9. Allergic constitution, such as those who are allergic to two or over twodrugs, with history of food allergies, or known to be allergic to the ingredients of this drug;
10. In the opinion of the investigator, subjects who are not suitable for enrollment or with any factors that affect the outcome of the trial.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recovery time;Pneumonia psi score;

Secondary Outcome Measures

Name	Time	Method
Exacerbation (transfer to RICU) time;Clearance rate and time of main symptoms (fever, fatigue, cough);Chest imaging score;Disappearance rate of single symptom in traditional Chinese Medicine;