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Renshen Fuling Decoction in reducing the mortality of patients with severe novel coronavirus infection: a randomized double-blind controlled clinical trial

Renshen Fuling Decoction in reducing the mortality of patients with severe novel coronavirus infection: a randomized double-blind controlled clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300067994
Enrollment
Unknown
Registered
2023-02-02
Start date
2023-02-03
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

SARS-Cov-2 infection disease

Interventions

Treatment Group:Renshen Fuling Decoction
Placebo:Renshen Fuling Decoction Simulant

Sponsors

The Second Affiliated Hospital of Zhejiang Chinese Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Severe inpatients who meet the diagnostic criteria for novel coronavirus infection; 2. Conforming to the diagnostic criteria of epidemic virus closed lung syndrome; 3. Age >= 18 years old; 4. Participate voluntarily, understand and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. patients with severe liver function impairment and active liver disease Andor alanine transferase or L-Aspartic Acid transferase levels >= 5 times the upper limit of normal; 2. the patients who received hemodialysis or EGFR < 30ml/min/1.73 m2(according to the MDRD equation) ; 3. patients with other severe organ failure or mental diseases, patients with severe depression, alcohol dependence or history of drug abuse; 4. allergic constitution or previous allergic to multiple drugs, or to the ingredients in the research drug allergy; 5. patients with a history of cancer or present cancer, or with precancerous lesions confirmed by pathological examination; 6. pregnant and lactating women and those who are preparing to give birth during or within 3 months after the cessation of medication; 7. patients who were considered not suitable to participate in this study by other investigators.

Design outcomes

Primary

MeasureTime frame
All-cause mortality (%) and the time from enrollment to death (d) on the 14th and 28th days;Rate of conversion from severe to critical within 14 days (%);Rate of mechanical ventilation with endotracheal intubation in severe patients (%) and time from admission to endotracheal intubation;

Secondary

MeasureTime frame
Rate and time of weaning mechanical ventilation;Time of nucleic acid turning negative;Improvement of TCM syndrome;Improvement of lung HRCT score;

Countries

China

Contacts

Public ContactLei Dong

The Second Affiliated Hospital of Zhejiang Chinese Medical University/ Zhejiang Chinese Medical University

20211087@zcmu.edu.cn+86 571 8526 7119

Outcome results

None listed

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