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A randomized, double-blind, placebo-controlled, dose-exploratory, multicenter clinical study of Reduning granules for the treatment of Covid-19

A randomized, double-blind, placebo-controlled, dose-exploratory, multicenter clinical study of Reduning granules for the treatment of Covid-19

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300068061
Enrollment
Unknown
Registered
2023-02-06
Start date
2023-02-06
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

COVID-19

Interventions

placebo group:Reduning pellets mimetic
High-dose group:Reduning pellets, 3g
low-dose group:Reduning pellets, 2g

Sponsors

Beijing Hospital of Traditional Chinese Medicine, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic criteria for COVID-19. Clinical typing of mild type; 2. Positive diagnostic result of SARS-CoV-2 antigen test in nasal/pharyngeal secretions; 3. Axillary temperature >=38.5°C at the time of consultation; 4. Duration of disease <= 48 hours (the time interval between patient onset and consultation does not exceed 48 hours); 5. The age ranges from 18 to 65 years old, regardless gender; 6. Signed an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Persons at high risk for COVID-19 in the severe/critical category; 2. Meet the early warning indicators for severe/critical type of COVID-19; 3. Patients with co-morbid other types of respiratory infections, including influenza, acute rhinitis, sinusitis, pharyngeal conjunctival fever, herpetic pharyngitis, tracheobronchitis, purulent tonsillitis disease and pneumonia; 4. Patients with combined severe malnutrition, rickets and combined severe primary diseases of the heart, brain, liver, kidney and hematopoietic systems; 5. Patients with immunodeficiency diseases or who have taken glucocorticoids or other immunosuppressive drugs within the last week; 6. Pregnant or lactating women, or women with the potential to become pregnant during the study period and within 3 months after the end of administration; 7. Here is a history of alcohol or drug abuse; 8. Those who have taken similar proprietary Chinese medicines or have been treated with antiviral drugs since the current onset; 9. Allergic constitution, such as those who have a history of allergy to two or more drugs or food or pollen, or who are known to be allergic to drug ingredients observed in this study; 10. A white blood cell count exceeding 10% of the upper limit of normal, or where the investigator suspects a co-infection with bacteria; 11. Patients who participated in or is currently participating in other clinical trials within the first month of this study; 12. Patients who are considered unsuitable for clinical trials by the researcher.

Design outcomes

Primary

MeasureTime frame
Disappearance time and rate of disappearance of major symptoms (fever, sore throat, myalgia, malaise);

Secondary

MeasureTime frame
Time of clinica disappearance rate;Time to disappearance/ disappearance rate of clinical symptoms;The effect time to fever reduction, recovery of body temperature;Time to disappearance/ disappearance rate of individual symptoms;Time to negative SARS-CoV-2 antigen test result/probability of negative result;Conversion rate of severe/critical illness;Use of emergency medications;Safety assessment Results: such as AEs and SAEs;

Countries

China

Contacts

Public ContactLiu Qingquan

Affiliated Hospital of Beijing Hospital of Traditional Chinese Medicine, Capital Medical University

liuqingquan2003@126.com+86 13910055687

Outcome results

None listed

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