CClinicalTrials.gg
Status unknownNCT04955223Updated Nov 15, 2022

Yinhu Qingwen Granule in the Treatment of Viral Pneumonia

An Early Phase 1 interventional study of Yinhu Qingwen Granules in Viral Pneumonia, sponsored by Zhong Wang. Status unknown at 2 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-15.

Sponsored by Zhong Wang · Early Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Early Phase 1
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Viral Pneumonia
03

In context

Pneumonia

2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.

This study's planned enrollment of 60 is below the median of 106 across 1,247 interventional studies indexed under Pneumonia.

Browse Pneumonia studies →

Lead sponsor

Zhong Wang is the lead sponsor of 12 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • 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

Interventions

  • DrugYinhu Qingwen Granules

    For mild and common patients, take 1 bag 2 times a day. For severe patients, take 1 bag 3 times a day.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: up to 30 days

Secondary outcomes

  1. 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

    Time frame: Baseline, Day 3, Day 7, Day 10 and Day 30

  2. 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 frame: up to 30 days

  3. 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.

    Time frame: Baseline, Day 3, Day 7, Day 10 and Day 30

  4. Mean blood oxygen saturation

    Time frame: Baseline, Day 3, Day 7, Day 10

  5. Mean neutrophil/lymphocyte ratio (NLR)

    Neutrophil/lymphocyte ratio (NLR) is obtained from the blood routine.

    Time frame: Baseline, Day 10

  6. Frequency of requirement for supplemental oxygen or non-invasive ventilation

    Time frame: up to 30 days

  7. Mean time of supplemental oxygen (days)

    Time frame: up to 30 days

  8. Mean time of non-invasive ventilation (days)

    Time frame: up to 30 days

  9. 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.

    Time frame: up to 30 days

  10. Proportion of re-hospitalization or admission to ICU

    Time frame: up to 30 days

  11. All-cause mortality

    Time frame: up to 30 days

  12. Frequency of serious adverse events

    Time frame: up to 30 days

07

Study locations

2 sites
  • Affiliated Hospital of Chengdu University of Traditional Chinese Medicine
    Chengdu, Sichuan 610072, China
    • Yun Lu, M.D. · Contact
  • Chengdu First People's Hospital/Chengdu integrated TCM & Western Medicine Hospital
    Chengdu, Sichuan 610095, China
    • Fengyun Chen, Prof. · Contact
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 15, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04955223
Lead sponsor
Zhong Wang
Responsible party
Zhong Wang (Professor, China Academy of Chinese Medical Sciences) — Sponsor-investigator
First posted
Jul 8, 2021
Start date
Dec 2022 (estimated)
Primary completion
Dec 2024 (estimated)
Completion
Dec 2024 (estimated)
Last update
Nov 15, 2022

Study contacts

Zhong Wang, M.D.
Contact
zhonw@vip.sina.com
+861064093305
Jun Liu, Ph.D.
Contact
franlj1104@aliyun.com
+861064093207

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion