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Effectiveness and safety of Fuzheng Jiedu granules in the treatment of COVID-19 - a multicenter, prospective observational study based on real world data

Effectiveness and safety of Fuzheng Jiedu granules in the treatment of COVID-19 - a multicenter, prospective observational study based on real world data

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200062389
Enrollment
Unknown
Registered
2022-08-04
Start date
2022-07-24
Completion date
Unknown
Last updated
2023-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19

Interventions

Treatment group:Fuzheng Jiedu granule + conventional western medicine treatment

Sponsors

The Second Affiliated Hospital of Guangzhou University of Chinese Medicine (Guangdong Provincial Hospital of Traditional Chinese Medicine)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Asymptomatic infections or patients diagnosed as mild/normal/severe/critical according to COVID-19 Diagnosis and Treatment Protocol (Version 9); 2. At least 18 years old; 3. The TCM syndrome differentiation was divided into Yang deficiency and wet toxin not clear; 4. Informed consent signed by the patient or their legal representative.

Exclusion criteria

Exclusion criteria: 1. Currently participating in other clinical trials

Design outcomes

Primary

MeasureTime frame
Proportion of patients with no progression of disease severity within 7 days;

Secondary

MeasureTime frame
Time to the TCM syndrome score 0;Proportion of patients transferred from makeshift accommodation to hospital within 7 days;;Proportion of disease severity without progression within 14 days;;Time to the symptom progression;;Percentage of patients with exacerbation and all-cause death within 14 days;;Time to persistent clinical symptoms disappear;;Percentage of patients with clinical symptoms disappeared;;Changes in COVID-19 symptom scores from baseline for patients with =1 score in any item on the baseline COVID-19 symptom scale;;Changes in single item score of COVID-19 related symptoms from baseline for patients with =1 score in any item on the baseline COVID-19 symptom scale;Changes of WHO Clinical Progress Scale score from baseline for patients with BASELINE WHO clinical Progress Scale score =1;Percentage of patients with baseline WHO CLINICAL Progress Scale score =1 decreased by at least 1 score from baseline;;Changes of SARS-COV-2 Ct value from baseline;Length of hospitalization;;Time to SARS-COV-2 NAAT negative;Changes in lymphocyte count, oxygen saturation (after 5 minutes of rest and exercise), oxygen concentration (FiO2), fatigue and sweating;Changes in chest CT scan image score from baseline at discharge;

Countries

China

Contacts

Public ContactZhongde Zhang
doctorzzd99@163.com+86 18602010082

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026