Yinhu Qingwen Granule in the Treatment of Viral Pneumonia

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Viral Pneumonia
• Intervention / Treatment: Drug: Yinhu Qingwen Granules

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Zhong Wang, M.D.; Phone Number: +861064093305; Email: zhonw@vip.sina.com
• Study Contact Backup: Name: Jun Liu, Ph.D.; Phone Number: +861064093207; Email: franlj1104@aliyun.com

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610072
      • Affiliated Hospital of Chengdu University of Traditional Chinese Medicine
      • Contact: Yun Lu, M.D.
    • Chengdu, Sichuan, China, 610095
      • Chengdu First People's Hospital/Chengdu integrated TCM & Western Medicine Hospital
      • Contact: Fengyun Chen, Prof.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Yinhu Qingwen Granule; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Mean blood oxygen saturation		Baseline, Day 3, Day 7, Day 10
Mean neutrophil/lymphocyte ratio (NLR)	Neutrophil/lymphocyte ratio (NLR) is obtained from the blood routine.	Baseline, Day 10
Frequency of requirement for supplemental oxygen or non-invasive ventilation		up to 30 days
Mean time of supplemental oxygen (days)		up to 30 days
Mean time of non-invasive ventilation (days)		up to 30 days
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
Proportion of re-hospitalization or admission to ICU		up to 30 days
All-cause mortality		up to 30 days
Frequency of serious adverse events		up to 30 days

Collaborators and Investigators

• Sponsor: Zhong Wang

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2022
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: July 4, 2021
• First Submitted That Met QC Criteria: July 4, 2021
• First Posted (Actual): July 8, 2021

Study Record Updates

• Last Update Posted (Actual): November 15, 2022
• Last Update Submitted That Met QC Criteria: November 14, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia; Pneumonia, Viral
• Other Study ID Numbers: YHQWKL V2.0

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No