Yinhu Qingwen Granule in the Treatment of Viral Pneumonia

NCT04955223 | Unknown Early Phase 1

• 1 other identifier: YHQWKL V2.0
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Viral Pneumonia

Outcome Measures

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.

  up to 30 days

Secondary Outcomes (12)

• Time to cough reported as mild or absent

  Baseline, Day 3, Day 7, Day 10 and Day 30

• Mean clinical recovery time (hours)

  up to 30 days

• Time to dyspnea reported as 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)

  Baseline, Day 10

Study Arms (1)

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.

Drug: Yinhu Qingwen Granules

Interventions

Yinhu Qingwen Granules DRUG

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

Yinhu Qingwen Granule

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhong Wang: lead

Study Sites (2)

Affiliated Hospital of Chengdu University of Traditional Chinese Medicine

Chengdu, Sichuan, 610072, China

Location

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

Chengdu, Sichuan, 610095, China

Location

MeSH Terms

Conditions

Pneumonia, Viral

Condition Hierarchy (Ancestors)

Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Zhong Wang, M.D.

CONTACT

+861064093305; zhonw@vip.sina.com

Jun Liu, Ph.D.

CONTACT

+861064093207; franlj1104@aliyun.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 4, 2021
• First Posted: July 8, 2021
• Study Start: December 1, 2022
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: November 15, 2022

Record last verified: 2022-11

Locations

CN (2)