The Use of Isatidis Root and Forsythia Oral Liquid for the Treatment of Mild Cases of COVID-19: A Trial Clinical Study

This study has significant implications for research, as it provides a basis for further studies on the antiviral effects of LGLQ Oral Liquid, encouraging more extensive clinical studies in larger populations and diverse age groups to validate these findings. For medical practice, the findings suggest that LGLQ can be considered an alternative treatment option for mild cases of COVID-19, especially in managing symptoms like fatigue, potentially broadening the range of effective treatments available to healthcare practitioners. In terms of policy, the demonstrated efficacy of LGLQ could lead to its inclusion in treatment guidelines for COVID-19 and other viral infections, fostering a more integrated approach combining Western medicine and Traditional Chinese Medicine in the global fight against pandemics. The insights from this study might prompt health policymakers to reassess the potential of herbal formulations in managing and treating infectious diseases and consider them in the development of future healthcare strategies and policies.

Study Overview

• Status: Completed
• Conditions: Treatment of Mild Cases of COVID-19
• Intervention / Treatment: Drug: Langenlianqiao; Drug: LianhuaQingWen; Other: placebo control group

• Study Type: Interventional
• Enrollment (Actual): 253
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Hunan
    • Changde, Hunan, China
      • Changde Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• the diagnosis of SARS-Cov-2 infection confirmed by quantitative polymerase chain reaction (qPCR) test
• aged 18 years or older
• patients received more than 2 doses of SARS-Cov-2 vaccine
• asymptomatic or mild at the time of hospitalization

Exclusion Criteria:

• patients with malignant diseases, autoimmune diseases, liver and kidney diseases, blood diseases, neurological diseases, endocrine diseases and other serious diseases may affect the patient's participation in the trial or affect the results of the study
• pregnant women, lactating mothers; allergic conditions
• allergic to the known components of the drug
• patients vaccinated with vaccines less than 1 shot
• Patient does not agree to participate in this study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LGLQ group	Drug: Langenlianqiao; The data of patients with COVID-19 mild disease treated in our Hospital from November to December 2022 were collected, and the patients were divided into 100 cases of langenlianqiao(LGLQ) treatment group, 100 cases of LianhuaQingWen(LHQW) treatment group, and 53 cases of placebo control group according to the treatments they received, and the proportion of occurrence of major clinical symptoms, the time of symptom disappearance, and the number of days in hospitalization, and the duration of infection were compared among the three groups.
Experimental: LHQW group	Drug: LianhuaQingWen; The data of patients with COVID-19 mild disease treated in our Hospital from November to December 2022 were collected, and the patients were divided into 100 cases of langenlianqiao(LGLQ) treatment group, 100 cases of LianhuaQingWen(LHQW) treatment group, and 53 cases of placebo control group according to the treatments they received, and the proportion of occurrence of major clinical symptoms, the time of symptom disappearance, and the number of days in hospitalization, and the duration of infection were compared among the three groups.
Placebo Comparator: placebo control group	Other: placebo control group; placebo control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment and symptomatic improvement effects of LGLQ	LGLQ and LHQW were able to significantly reduce the duration of infection with novel coronaviruses	1 month

Collaborators and Investigators

• Sponsor: Central South University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Actual): December 30, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: April 8, 2024
• First Submitted That Met QC Criteria: April 8, 2024
• First Posted (Actual): April 9, 2024

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: MZhou

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No