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CompletedNCT06355193Updated Apr 9, 2024

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

A Phase 1 interventional study of Langenlianqiao and LianhuaQingWen in Treatment of Mild Cases of COVID-19, sponsored by Central South University. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-09.

Sponsored by Central South University · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 5 months after the study started (first participant enrolled Nov 2022, registered Apr 2024).
Phase
Phase 1
Study type
Interventional
Enrollment
253
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Treatment of Mild Cases of COVID-19

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03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 253 is above the median of 100 across 4,099 interventional studies indexed under COVID-19.

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Lead sponsor

Central South University is the lead sponsor of 126 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
253 participants (actual)

Study arms

  • Experimental
    LGLQ group

    Drug: Langenlianqiao

  • Experimental
    LHQW group

    Drug: LianhuaQingWen

  • Placebo comparator
    placebo control group

    Other: placebo control group

Interventions

  • DrugLangenlianqiao

    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.

  • DrugLianhuaQingWen

    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.

  • Otherplacebo control group

    placebo control group

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What researchers measure

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

    Time frame: 1 month

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Study locations

1 site
  • Changde Hospital
    Changde, Hunan, China
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06355193
Lead sponsor
Central South University
Responsible party
Mi Zhou (Investigator, Central South University) — Principal investigator
First posted
Apr 9, 2024
Start date
Nov 1, 2022
Primary completion
Dec 30, 2022
Completion
Dec 31, 2022
Last update
Apr 9, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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