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A randomized, open-label, blank-controlled trial for Lian-Hua Qing-Wen Capsule/Granule in the treatment of suspected novel coronavirus pneumonia (COVID-19)

A randomized, open-label, blank-controlled trial for Lian-Hua Qing-Wen Capsule/Granule in the treatment of suspected novel coronavirus pneumonia (COVID-19)

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2000002949
Enrollment
Unknown
Registered
2020-02-01
Start date
2020-02-01
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

suspected novel coronavirus pneumonia (COVID-19)

Interventions

Sponsors

Hebei Yiling Hospital\Renmin Hospital of Wuhan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Those who meet the diagnostic criteria for suspected cases in the diagnosis and treatment scheme; 2. Over 18 years old (including 18 years old), male or female; 3. At the time of enrollment, the patient had any of the main symptoms (fever, cough, fatigue); 4. Voluntarily sign a written informed consent before the study begins.

Exclusion criteria

Exclusion criteria: 1. Respiratory tract infection caused by primary immunodeficiency disease, acquired immunodeficiency syndrome, congenital respiratory tract malformation, congenital heart disease, gastroesophageal reflux disease, abnormal lung development and other basic diseases, with clear evidence of bacterial infection; 2. Subjects with the following conditions: daily treatment of asthma, any other chronic respiratory diseases, respiratory bacterial infections such as suppurative tonsillitis, acute tracheal bronchitis, sinusitis, otitis media and other respiratory diseases that affect clinical trial evaluation.Chest CT confirmed the existence of severe pulmonary interstitial lesions, bronchiectasis and other basic pulmonary diseases; 3. Severe pneumonia requiring mechanical ventilation; 4. In the judgment of the investigator, the previous or current diseases may affect the patient's participation in the trial or the outcome of the study, including malignant diseases, autoimmune diseases, liver and kidney diseases, blood diseases, nervous system diseases, and endocrine diseases;The patient is suffering from serious diseases that affect the immune system, such as human immunodeficiency virus (HIV) infection, or blood system, or splenectomy, organ transplantation, etc.; 5. Pregnant or lactating women; 6. Patients who participated in other clinical trials within the last 3 months; 7. Allergic constitution, such as a history of allergy to two or more drugs or food, or a known allergy to the ingredients of the drug; 8. The investigator considers that there are any factors that are inappropriate for inclusion or affect the evaluation of the efficacy.

Design outcomes

Primary

MeasureTime frame
Clinical symptoms (fever, weakness, cough) recovery rate and recovery time;

Secondary

MeasureTime frame
Biochemical Indicators;Rate of CT improvement;Proportion of aggravation during treatment (in line with the definition of severe or critical illness in the treatment scheme);Disease recovery rate;Single symptom disappearance rate and main symptom disappearance time;Routine blood test;

Countries

China

Contacts

Public ContactZhong Nanshan/Zhang Boli/Li Lanjuan/Duan Zhongping/Li Xingwang/Liu Qingquan/Song Yuanlin/Jia Zhenhua

Shijiazhuang Yiling Pharmaceutical Co., Ltd.

jiactm@163.com+86 0311-83855881

Outcome results

None listed

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