Yinhu Qingwen Granule in the Treatment of Viral Pneumonia

NCT ID: NCT04955223

Last Updated: 2022-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-31

Study Completion Date

2024-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Viral Pneumonia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Yinhu Qingwen Granules

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Zhong Wang

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Zhong Wang

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Affiliated Hospital of Chengdu University of Traditional Chinese Medicine

Chengdu, Sichuan, China

Site Status

Chengdu First People's Hospital/Chengdu integrated TCM & Western Medicine Hospital

Chengdu, Sichuan, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Zhong Wang, M.D.

Role: CONTACT

+861064093305

Jun Liu, Ph.D.

Role: CONTACT

+861064093207

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Yun Lu, M.D.

Role: primary

Fengyun Chen, Prof.

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

YHQWKL V2.0

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

A Phase I Study in Healthy Participants
NCT06277167 COMPLETED PHASE1