Efficacy of Lianhua Qingwen in Treating Patients Infected With the Omicron Variant of the COVID-19

COVID-19 Pneumonia Clinical Trial

Official title:

Efficacy of Lianhua Qingwen in Treating Patients Infected With the Omicron Variant of the COVID-19

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05778318
• Other study ID #: YXLL-KY-2022(095)
• Status: Recruiting
• Start date: March 20, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: May 2023
• Source: Qianfoshan Hospital
• Contact: Qian Qi, Dr.
• Phone: +86 13706380314
• Email: qiqianqlh[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

A retrospective analysis was conducted on patients infected with the Omicron variant of COVID-19 diagnosed from August 2022 to now. Patients were divided into observation groups and control groups according to whether or not oral Lianhua Qingwen granules were used. Through data analysis and follow-up, the effectiveness of Lianhua Qingwen in treating patients infected with the Omicron variant of COVID-19 was discussed.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• For patients infected with the Omicron variant, the diagnostic criteria are confirmed cases of COVID-19 and clinical classification according to the diagnostic criteria of Prevention and Control Protocol for COVID-19 (Trial Eighth Edition) issued by the National Health and Construction Commission.

• The clinical symptoms were classified as mild or ordinary.

• They have been vaccinated against the COVID-19.

Exclusion Criteria:

• Patients receiving antiviral or antibiotic drugs

• Severe and critical patients with COVID-19.

• Patients with chronic respiratory diseases, bacterial infections of the respiratory system, and other respiratory diseases affecting the study.

• Patients with serious primary diseases of the heart, brain, lung, liver, kidney, and hematopoietic systems, as well as mental diseases.

• Allergic reaction to Lianhua Qingwen granules.

• Excluded patients treated with the same drug as Lianhua Qingwen.

Related Conditions & MeSH terms

• COVID-19
• COVID-19 Pneumonia

Intervention

Drug:
• The group of patients who received Lianhua Qingwen orally
Lianhua Qingwen Granules: oral. One bag at a time, three times a day. The course of treatment for mild and ordinary cases of novel coronavirus pneumonia is 7-10 days.

Other:
• The group of patients who did not receive Lianhua Qingwen orally
The group of patients who did not receive Lianhua Qingwen orally.

Locations

Country	Name	City	State
China	Department of Respiratory, The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital, #16766, Jingshi Road, Jinan City, Shandong Province, China	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Qianfoshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disappearance rate of symptoms	Disappearance rate of symptoms (fever, fatigue, cough)	two weeks