An observational study for Xin-Guan-1 formula in the treatment of novel coronavirus pneumonia (COVID-19)

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Observational

Source

ITMCTR

Registry ID

ITMCTR2000002980

Enrollment

Unknown

Registered

2020-02-08

Start date

2020-02-07

Completion date

Unknown

Last updated

2023-02-20

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

Conditions

novel coronavirus pneumonia (COVID-19)

Interventions

Experimental group:Xinguan-1 formula+Standard treatment

Control group:Standard treatment

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients who meet the diagnostic criteria of Hubei Province pneumonia infected by novel coronavirus(2019-nCoV), and clinical classification of mild, moderate and severe were included.

Exclusion criteria

Exclusion criteria: ?Allergic constitution, ie, allergic history to 2 or more kinds of medicine or food, or to the medicines of our study. ?Patients who do not agree with taking traditional Chinese medicine.

Design outcomes

Primary

Measure	Time frame
Time to remission/disappearance of primary symptoms: defined as the number of days when the three main symptoms of fever, cough, and shortness of breath are all relieved / disappeared;Completely antipyretic time: completely antipyretic was defined as the body temperature return to normal for over 24 hours.;	—

Secondary

Measure	Time frame
Routine blood test;Time to 2019-nCoV RT-PCR negativity: defined as the last test time for two consecutive negative respiratory viral nucleic acid tests (sampling interval of at least 1 day);Blood oxygen saturation;Length of hospital stay: defined as the time from the start of isolation treatment for n-CoV pneumonia to the time when the isolation is released from the hospital or transferred to the appropriate department for other diseases according to the condition;Blood gas analysis;C-reactive protein;Incidence of medical complications during hospitalization: defined as medical complications during pneumonia isolation hospitalization due to novel coronavirus infection, including combined bacterial infections, exacerbation of underlying diseases, etc;Conversion of severe and critical cases: defined as the number of severe and critical cases that occurred after the study was included and the intervention was initiated;Chest imaging;Liver and renal function;	—

Measure

Time frame

Routine blood test;Time to 2019-nCoV RT-PCR negativity: defined as the last test time for two consecutive negative respiratory viral nucleic acid tests (sampling interval of at least 1 day);Blood oxygen saturation;Length of hospital stay: defined as the time from the start of isolation treatment for n-CoV pneumonia to the time when the isolation is released from the hospital or transferred to the appropriate department for other diseases according to the condition;Blood gas analysis;C-reactive protein;Incidence of medical complications during hospitalization: defined as medical complications during pneumonia isolation hospitalization due to novel coronavirus infection, including combined bacterial infections, exacerbation of underlying diseases, etc;Conversion of severe and critical cases: defined as the number of severe and critical cases that occurred after the study was included and the intervention was initiated;Chest imaging;Liver and renal function;

—

Countries

China

Contacts

Public ContactZhang Zhongde

Guangdong Provincial Hospital of Chinese Medicine

doctorzzd99@163.com+86 13903076359

Outcome results

None listed

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