Yinhu Qingwen Granule in the Treatment of Viral Pneumonia

Viral Pneumonia Clinical Trial

Official title:

Non-random Single-arm Clinical Study of Yinhu Qingwen Granule in the Treatment of Viral Pneumonia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04955223
• Other study ID #: YHQWKL V2.0
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: December 2022
• Est. completion date: December 2024

Study information

• Verified date: November 2022
• Source: China Academy of Chinese Medical Sciences
• Contact: Zhong Wang, M.D.
• Phone: +861064093305
• Email: zhonw[@]vip.sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pneumonia
• Pneumonia, Viral
• Viral Pneumonia

Intervention

Drug:
• Yinhu Qingwen Granules
For mild and common patients, take 1 bag 2 times a day. For severe patients, take 1 bag 3 times a day.

Locations

Country	Name	City	State
China	Affiliated Hospital of Chengdu University of Traditional Chinese Medicine	Chengdu	Sichuan
China	Chengdu First People's Hospital/Chengdu integrated TCM & Western Medicine Hospital	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Zhong Wang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to the normalization of the temperature	The normalization of the temperature is defined as that the temperature of the patient dropped to normal and stabilized for more than 72 hours.	up to 30 days
Secondary	Time to cough reported as mild or absent	The severity of cough is assessed using Cough Symptom Scale, a scale range from 0-6. 0: cough absent;1-2: mild; 3-4:moderate; 5-6: severe	Baseline, Day 3, Day 7, Day 10 and Day 30
Secondary	Mean clinical recovery time (hours)	The clinical recovery time is defined as the time from initiation of study treatment (active or placebo) until normalisation of fever, respiratory rate, and oxygen saturation, and alleviation of cough, sustained for at least 72 hours.; Normalisation and alleviation criteria: (1) Fever: =36.6°C or -axilla, =37.2 °C oral or =37.8°C rectal or tympanic;(2)Respiratory rate - =24/minute on room air; 3) Oxygen saturation - >94% on room air; (4) Cough - mild or absent on a patient reported scale (cough symptoms score = 2 points).	up to 30 days
Secondary	Time to dyspnea reported as mild or absent	The severity of dyspnea is assessed on a self-reported scale of severe, moderate, mild or absent.	Baseline, Day 3, Day 7, Day 10 and Day 30
Secondary	Mean blood oxygen saturation		Baseline, Day 3, Day 7, Day 10
Secondary	Mean neutrophil/lymphocyte ratio (NLR)	Neutrophil/lymphocyte ratio (NLR) is obtained from the blood routine.	Baseline, Day 10
Secondary	Frequency of requirement for supplemental oxygen or non-invasive ventilation		up to 30 days
Secondary	Mean time of supplemental oxygen (days)		up to 30 days
Secondary	Mean time of non-invasive ventilation (days)		up to 30 days
Secondary	Severe case incidence	Severe case is defined as respiratory rate =30/minute on room air;or Oxygen saturation - =94% on room air;or PaO2/FiO2=300mmHg.	up to 30 days
Secondary	Proportion of re-hospitalization or admission to ICU		up to 30 days
Secondary	All-cause mortality		up to 30 days
Secondary	Frequency of serious adverse events		up to 30 days