Viral PneumoniaEarly Phase 1NCT04955223
Yinhu Qingwen Granule in the Treatment of Viral Pneumonia
A Early Phase 1 study testing Yinhu Qingwen Granules in people with Viral Pneumonia, run by Zhong Wang at 2 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Viral Pneumonia
- What is being tested?
- Yinhu Qingwen Granules
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesChina
- Study dates
- Dec 2022to Dec 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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 locations and contacts
2 sites in 1 country.
China2 sites
Affiliated Hospital of Chengdu University of Traditional Chinese Medicine
Chengdu, Sichuan, 610072
Yun Lu, M.D.
Chengdu First People's Hospital/Chengdu integrated TCM & Western Medicine Hospital
Chengdu, Sichuan, 610095
Fengyun Chen, Prof.
About this study
Official title: 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.
Read the 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.
- Conditions
- Viral Pneumonia
- Being tested
- Yinhu Qingwen Granules
- Medical subject headings
- Pneumonia, Viral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yinhu Qingwen GranulesDrug
For mild and common patients, take 1 bag 2 times a day. For severe patients, take 1 bag 3 times a day.
| Study group | Role | What they receive |
|---|---|---|
| Yinhu Qingwen Granule | Experimental | 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. Receives: Drug: Yinhu Qingwen Granules |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 30 days
Secondary outcomes (12)
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
Measured: 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).
Measured: 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.
Measured: Baseline, Day 3, Day 7, Day 10 and Day 30
Mean blood oxygen saturation
Measured: Baseline, Day 3, Day 7, Day 10
Mean neutrophil/lymphocyte ratio (NLR)
Neutrophil/lymphocyte ratio (NLR) is obtained from the blood routine.
Measured: Baseline, Day 10
Frequency of requirement for supplemental oxygen or non-invasive ventilation
Measured: up to 30 days
Mean time of supplemental oxygen (days)
Measured: up to 30 days
Mean time of non-invasive ventilation (days)
Measured: 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.
Measured: up to 30 days
Proportion of re-hospitalization or admission to ICU
Measured: up to 30 days
All-cause mortality
Measured: up to 30 days
Frequency of serious adverse events
Measured: up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study startDec 2022 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Viral PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhong Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhong Wang, China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04955223
- Sponsor's protocol ID
- YHQWKL V2.0
- Status last verified
- Nov 2022
- First submitted
- 4 Jul 2021
- Last updated
- 15 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-random Single-arm Clinical Study of Yinhu Qingwen Granule in the Treatment of Viral Pneumonia
- ClinicalTrials.gov ID
- NCT04955223
- Acronym / sponsor ID
- YHQWKL V2.0
- Conditions
- Viral Pneumonia
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Zhong WangUniversity, hospital or other
- Study start
- Dec 2022 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 8 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Yinhu Qingwen Granule | Experimental | Drug: Yinhu Qingwen GranulesFor 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yinhu Qingwen GranulesFor mild and common patients, take 1 bag 2 times a day. For severe patients, take 1 bag 3 times a day. | Drug | Yinhu Qingwen Granule |
Primary outcome
Time to the normalization of the temperature
Time frame: up to 30 days
The normalization of the temperature is defined as that the temperature of the patient dropped to normal and stabilized for more than 72 hours.
12 secondary outcomes
Time to cough reported as mild or absent
Time frame: Baseline, Day 3, Day 7, Day 10 and Day 30
Mean clinical recovery time (hours)
Time frame: up to 30 days
Time to dyspnea reported as mild or absent
Time frame: Baseline, Day 3, Day 7, Day 10 and Day 30
Mean blood oxygen saturation
Time frame: Baseline, Day 3, Day 7, Day 10
Mean neutrophil/lymphocyte ratio (NLR)
Time frame: Baseline, Day 10
Frequency of requirement for supplemental oxygen or non-invasive ventilation
Time frame: up to 30 days
Mean time of supplemental oxygen (days)
Time frame: up to 30 days
Mean time of non-invasive ventilation (days)
Time frame: up to 30 days
Severe case incidence
Time frame: up to 30 days
Proportion of re-hospitalization or admission to ICU
Time frame: up to 30 days
All-cause mortality
Time frame: up to 30 days
Frequency of serious adverse events
Time frame: up to 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Yinhu Qingwen Granules in people with Viral Pneumonia, run by Zhong Wang at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhong Wang, M.D. (+861064093305, zhonw@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to the normalization of the temperature (time frame: up to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2022.