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

NCT05778318 | Unknown

• 1 other identifier: YXLL-KY-2022(095)
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COVID-19 Pneumonia

Outcome Measures

Primary Outcomes (1)

• Disappearance rate of symptoms

  Disappearance rate of symptoms (fever, fatigue, cough)

  two weeks

Study Arms (2)

Control group

Patients without Lianhua Qingwen treatment.

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

Observation Group

Patients with Lianhua Qingwen treatment.

Drug: The group of patients who received Lianhua Qingwen orally

Interventions

The group of patients who received Lianhua Qingwen orally DRUG

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.

Observation Group

The group of patients who did not receive Lianhua Qingwen orally OTHER

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

Control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

① For patients infected with the Omicron variant of COVID-19, the diagnostic criteria are confirmed cases of COVID-19 and clinical classification according to the diagnostic criteria of Prevention and Control Protocol for Novel Coronavirus Pneumonia (Trial Eighth Edition) issued by the National Health and Construction Commission; ② The clinical symptoms were classified as mild or ordinary; ③ They have been vaccinated against the COVID-19.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qianfoshan Hospital: lead

Study Sites (1)

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, China

RECRUITING

Central Study Contacts

Qian Qi, Dr.

CONTACT

+86 13706380314; qiqianqlh@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: March 20, 2023
• First Posted: March 21, 2023
• Study Start: March 20, 2023
• Primary Completion: April 30, 2024
• Study Completion: June 30, 2024
• Last Updated: May 11, 2023

Record last verified: 2023-05

Locations

CN (1)