Yinhu Qingwen Granule in the Treatment of Viral Pneumonia

Zhong Wang

Status and phase: Not yet enrolling; Early Phase 1

Conditions: Viral Pneumonia

Treatments: Drug: Yinhu Qingwen Granules

Study type: Interventional

Funder types: Other

Identifiers

NCT04955223

YHQWKL V2.0

Details and patient eligibility

About

This is a non-randomized single arm clinical study to observe the effect of Yinhu Qingwen Granule in the relief of fever and improvement of related-symptoms of patients with viral pneumonia.

Full description

Preliminary pharmacodynamic and toxicological studies can show that Yinhu Qingwen Granule has a certain effect on pneumonia caused by various viruses, and its safety is good. This study aims to observe the effect of Yinhu Qingwen Granule in the relief of fever and improvement of related-symptoms of patients with viral pneumonia.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of viral pneumonia;
• Clinical diagnosis of Shi-du-yun-jie Zheng (damp stagnation syndrome) according to Chinese medicine, including fever,cough,sore throat,stuffy chest,irritability and thirst,short yellow urine,constipation or loose stool,thick and greasy yellow coating,and slippery pulse;
• Chest CT showed signs of acute exudative pneumonia in the lungs;
• Over 18 years old, regardless of gender, voluntarily signed an informed consent form;
• Those who were hospitalized and were accompanied by fever (body temperature ≥37.3℃) and respiratory tract symptoms like cough or dyspnea, when they were enrolled.

Exclusion criteria

• Patients that are susceptible to sensitivity or known to be allergic to the study drug;
• Patients whose white blood cell count ≥12×10^9 or neutrophil percentage ≥80%;
• Patients whose weight is less than 40 kg;
• Patients with respiratory failure or need mechanical ventilation;
• Patients with shock;
• Patients required to be in ICU monitoring and treatment;
• Patients participated in other clinical trials within 1 month;
• Patients with known renal impairment;
• Patients with any of the following laboratory parameter abnormalities during the screening period or within 24 hours before screening: ALT or AST level> 5 times the upper limit of normal range (ULN) or-ALT or AST level > 3 times ULN and total bilirubin level> 2 times ULN;
• Patients with immune system diseases and long-term use of immunosuppressive agents;
• Pregnant or breastfeeding women, or who have a positive pregnancy test during the screening period, or plan to become pregnant within 3 months after the study treatment.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Yinhu Qingwen Granule

Experimental group

Description:

For mild and common patients, take 1 bag 2 times a day. For severe patients, take 1 bag 3 times a day. All treatment should be used for 10 days unless all the symtopms of patient with the viral pneumonia are relieved.

Treatment:

Drug: Yinhu Qingwen Granules