Back to resultsYinhu Qingwen Granule in the Treatment of Viral Pneumonia
Primary Purpose
Viral Pneumonia
Status
Not yet recruiting
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
Yinhu Qingwen Granules
Sponsored by
About this trial
This is an interventional treatment trial for Viral Pneumonia
Eligibility Criteria
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.
Sites / Locations
- Affiliated Hospital of Chengdu University of Traditional Chinese Medicine
- Chengdu First People's Hospital/Chengdu integrated TCM & Western Medicine Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Yinhu Qingwen Granule
Arm 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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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).
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.
Mean blood oxygen saturation
Mean neutrophil/lymphocyte ratio (NLR)
Neutrophil/lymphocyte ratio (NLR) is obtained from the blood routine.
Frequency of requirement for supplemental oxygen or non-invasive ventilation
Mean time of supplemental oxygen (days)
Mean time of non-invasive ventilation (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.
Proportion of re-hospitalization or admission to ICU
All-cause mortality
Frequency of serious adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04955223
Brief Title
Yinhu Qingwen Granule in the Treatment of Viral Pneumonia
Official Title
Non-random Single-arm Clinical Study of Yinhu Qingwen Granule in the Treatment of Viral Pneumonia
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2022 (Anticipated)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Zhong Wang
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Viral Pneumonia
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Yinhu Qingwen Granule
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Yinhu Qingwen Granules
Intervention Description
For mild and common patients, take 1 bag 2 times a day. For severe patients, take 1 bag 3 times a day.
Primary Outcome Measure Information:
Title
Time to the normalization of the temperature
Description
The normalization of the temperature is defined as that the temperature of the patient dropped to normal and stabilized for more than 72 hours.
Time Frame
up to 30 days
Secondary Outcome Measure Information:
Title
Time to cough reported as mild or absent
Description
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
Time Frame
Baseline, Day 3, Day 7, Day 10 and Day 30
Title
Mean clinical recovery time (hours)
Description
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).
Time Frame
up to 30 days
Title
Time to dyspnea reported as mild or absent
Description
The severity of dyspnea is assessed on a self-reported scale of severe, moderate, mild or absent.
Time Frame
Baseline, Day 3, Day 7, Day 10 and Day 30
Title
Mean blood oxygen saturation
Time Frame
Baseline, Day 3, Day 7, Day 10
Title
Mean neutrophil/lymphocyte ratio (NLR)
Description
Neutrophil/lymphocyte ratio (NLR) is obtained from the blood routine.
Time Frame
Baseline, Day 10
Title
Frequency of requirement for supplemental oxygen or non-invasive ventilation
Time Frame
up to 30 days
Title
Mean time of supplemental oxygen (days)
Time Frame
up to 30 days
Title
Mean time of non-invasive ventilation (days)
Time Frame
up to 30 days
Title
Severe case incidence
Description
Severe case is defined as respiratory rate ≥30/minute on room air；or Oxygen saturation - ≤94% on room air；or PaO2/FiO2≤300mmHg.
Time Frame
up to 30 days
Title
Proportion of re-hospitalization or admission to ICU
Time Frame
up to 30 days
Title
All-cause mortality
Time Frame
up to 30 days
Title
Frequency of serious adverse events
Time Frame
up to 30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhong Wang, M.D.
Phone
+861064093305
Email
zhonw@vip.sina.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jun Liu, Ph.D.
Phone
+861064093207
Email
franlj1104@aliyun.com
Facility Information:
Facility Name
Affiliated Hospital of Chengdu University of Traditional Chinese Medicine
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610072
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yun Lu, M.D.
Facility Name
Chengdu First People's Hospital/Chengdu integrated TCM & Western Medicine Hospital
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610095
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fengyun Chen, Prof.
12. IPD Sharing Statement
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Yinhu Qingwen Granule in the Treatment of Viral Pneumonia
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