A randomized controlled study to evaluate the efficacy and safety of Fufang Yinhua detoxification granules in COVID-19 infectio

Phase 4

• Conditions: COVID-19

• Registration Number: ITMCTR2200006859
• Lead Sponsor: Yixing People's Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 6 March 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1) Clinically diagnosed with COVID-19 classificated according to the Diagnosis and Treatment Protocol for COVID-19 (Trial Version 9 formulated by the National Health Commission;
2) SARS-CoV-2 nucleic acid test is positive;
3) Age =18 years old;
4) Infected subjects with clinical symptoms (fever, cough, sore throat, fatigue, etc.) or abnormal of hematology;
5) Subjects fully understand and participate this trial voluntarily, and sign Informed Consent Form.

Exclusion Criteria

1) Subjects who have used drugs with pharmacological or clinical effects against novel coronavirus or traditional Chinese medicine containing similar ingredients to the study drug within 5 days prior to screening, including but not limited to Jinhua Qinggan, Lianhua Qingwen, Radix isatidis, Paxlovid, Azifudine, etc.;
2) Subjects receiving COVID-19 monoclonal antibodies, convalescent plasma, or other concomitant drugs within 28 days prior to screening;
3) Subjects who had SARS-CoV-2 vaccination within 28 days prior to screening or who planned to vaccinateSARS-CoV-2 during the visit and follow-up period;
4) Immunodeficient subjects (such as patients with malignant tumors, organ or bone marrow transplants, AIDS patients, long-term use of corticosteroids or other immunosuppressive drugs resulting in immune dysfunction);
5) Subjects with serious cardiovascular and cerebrovascular diseases, chronic pulmonary diseases (chronic obstructive pulmonary disease, moderate to severe asthma, interstitial pulmonary disease), inadequately controlleddiabetes, tumor and other underlying diseases;
6) Subjects who are allergic to the ingredients contained in the study drug, or subjects are in allergic constitution;
7) Medicalhistory of gastrointestinal diseases that affect drug absorption (including but not limited to reflux esophagitis, chronic diarrhea, inflammatory bowel disease, intestinal tuberculosis, gastrinoma, short bowel syndrome, post-subtotal gastrectomy, etc.);
8) Women in the lactation or pregnancy period;
9) Suspected or confirmed history of alcohol, drug abuse or mental illness;
10) Subjects who participated in other clinical trials of drugs within 1 month before screening;
11) Any other factor that the investigator considered unsuitable for participation.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time between initial administration and recovery of clinical symptoms (e.g. fever, cough, sore throat, fatigue, etc.);

Secondary Outcome Measures

Name	Time	Method
Changes of blood routine before and after administration;Proportion of subjects who progressed to normal, severe or critical COVID-19;Time between initial administration and nucleic acid turning negative for the first time;