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Fuzheng Jiedu Granules for High-Risk Adults with Covid-19-a Double-blind, Randomized, Controlled trial

Fuzheng Jiedu Granules for High-Risk Adults with Covid-19-a Double-blind, Randomized, Controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200058181
Enrollment
Unknown
Registered
2022-03-31
Start date
2021-10-21
Completion date
Unknown
Last updated
2023-12-10

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

Conditions

COVID-19

Interventions

FZJDG:Conventional therapy+FZJDG,1 bag (15g) each time, 3 times a day
Control group:Conventional therapy

Sponsors

The Second Affiliated Hospital of Guangzhou University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Confirmed Covid-19 patients according to Scheme for Diagnosis and Treatment of 2019 Novel Coronavirus Pneumonia(The 8th Trial Edition); 2. Age>=18 years old; 3. Adults who have at least one following characteristic associated with a high risk of progression to severe Covid-19: (1) >60 years old; (2) People with underlying diseases such as cardiovascular disease (including hypertension), chronic lung disease, diabetes mellitus, chronic liver and kidney disease, tumors; (3) Immune deficiency (e.g. AIDS patients, long-term use of corticosteroids or other immunosuppressive drugs leading to a hypoimmune state); (4) Obesity (BMI>=30); (5) Women in late pregnancy and perinatal period; (6) Heavy smokers. Or emerging warning indicators of progression to severe/critical disease: (1) Hypoxemia or progressive worsening of respiratory distress; (2) Decrease of tissue oxygenation indicators (e.g. finger oxygen saturation, oxygenation index) or progressive elevation of lactate; (3) Progressive decrease in peripheral blood lymphocyte count or progressive increase in inflammatory factors such as interleukin 6, CRP, ferritin, etc.; (4) Marked elevation of coagulation-related indicators such as D-dimer; (5) Marked progression of lung lesions on chest imaging. 4. Those who agree to participate in this study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Already progressed to heavy/critical Covid-19 prior to enrollment; 2. Allergic or allergic to known herbal medicines; 3. Unwilling to take herbal medicines; 4. Those previously infected with SARS-CoV-2; 5. Assessed by a physician to be unsuitable for inclusion.

Design outcomes

Primary

MeasureTime frame
The proportion of patients who progressed to a severe disease status;

Secondary

MeasureTime frame
Shortness of breath with a respiratory rate (RR) =30/min and peripheral blood oxygen saturation =93% in resting state;The proportion of tracheotomy, intubation, and invasive mechanical ventilation;Incidence of complications.;Proportion of ICU admissions;Length of hospital stay;Concomitant symptoms when discharge;Morbidity rate;The proportion of high-flow nasal-catheter oxygenation (HFNC) and Noninvasive Mechanical Ventilation;Time to symptom recovery;

Countries

China

Contacts

Public ContactZhongde Zhang

The Second Affiliated Hospital of Guangzhou University of Chinese Medicine

doctorzzd99@163.com+86 13560021023

Outcome results

None listed

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