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

NCT06355193 | Completed Phase 1

• 1 other identifier: MZhou
• Study Type: interventional
• Target: 253
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Treatment of Mild Cases of COVID-19

Outcome Measures

Primary Outcomes (1)

• Treatment and symptomatic improvement effects of LGLQ

  LGLQ and LHQW were able to significantly reduce the duration of infection with novel coronaviruses

  1 month

Study Arms (3)

LGLQ group

EXPERIMENTAL

Drug: Langenlianqiao

LHQW group

EXPERIMENTAL

Drug: LianhuaQingWen

placebo control group

PLACEBO COMPARATOR

Other: placebo control group

Interventions

Langenlianqiao DRUG

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.

LGLQ group

LianhuaQingWen DRUG

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.

LHQW group

placebo control group OTHER

placebo control group

placebo control group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Central South University: lead

Study Sites (1)

Changde Hospital

Changde, Hunan, China

Location

MeSH Terms

Interventions

lianhuaqingwen

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: April 8, 2024
• First Posted: April 9, 2024
• Study Start: November 1, 2022
• Primary Completion: December 30, 2022
• Study Completion: December 31, 2022
• Last Updated: April 9, 2024

Record last verified: 2024-04

Locations

CN (1)