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

May 9, 2023 updated by: Qian Qi, Qianfoshan Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China
        • Recruiting
        • Department of Respiratory, The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital, #16766, Jingshi Road, Jinan City, Shandong Province, China
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control group
Patients without Lianhua Qingwen treatment.
Other: The group of patients who did not receive Lianhua Qingwen orally
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disappearance rate of symptoms
Time Frame: two weeks
Disappearance rate of symptoms (fever, fatigue, cough)
two weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qianfoshan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 20, 2023

Primary Completion (Anticipated)

April 30, 2024

Study Completion (Anticipated)

June 30, 2024

Study Registration Dates

First Submitted

March 20, 2023

First Submitted That Met QC Criteria

March 20, 2023

First Posted (Actual)

March 21, 2023

Study Record Updates

Last Update Posted (Estimate)

May 11, 2023

Last Update Submitted That Met QC Criteria

May 9, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YXLL-KY-2022(095)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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