A pilot study for Integrated Chinese and Western Medicine in the treatment of non-critical novel coronavirus pneumonia (COVID-19)

A multicenter, randomized, open-label, parallel controlled trial for the safety and efficacy of Integrated Chinese and Western Medicine in treatment of non-critical novel coronavirus pneumonia (COVID-19): pilot study

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ITMCTR

Registry ID

ITMCTR2000003085

Enrollment

Unknown

Registered

2020-02-18

Start date

2020-02-20

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

control group:standard therapy

group A:Arbidol Hydrochloride Tablets, Liushen Capsule, standard therapy

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged>= 18, male or female; 2. Fever, axillary temperature > 37.3 degrees; 3. Consistent with the clinical diagnosis of COVID-19 mild, normal, severe case; 4. Patients who sign informed consent form freely and voluntarily.

Exclusion criteria

Exclusion criteria: 1. Critical case with the following situation: i. Patients with respiratory failure and needing mechanical ventilation; ii. Patients with shock; iii. Patients with other organ failures and needing ICU monitoring and treatment; 2. Patients who have other respiratory tract infection; 3. Patients used Liu Shen Capsule within 1 month before screening; 4. Allergic constitution patients, who are allergic to the drugs used in this research; 5. Lactating or pregnant females, or urine pregnancy test was positive or did not agree to use contraception 3 months after the trial; 6. Immunodeficiency (such as a malignant tumor, solid organ or bone marrow transplant, aids, using immunosuppressive drugs within 3 months before screening); 7. Severe liver insufficiency (ALT or AST > 5ULN, or ALT or AST > 3ULN with BIL > 3ULN); Severe renal insufficiency (Ccr < 50ml/min, estimated by Scr); 8. Patients who do-not-resuscitate; 9. The researchers consider the patients are not suitable.

Design outcomes

Primary

Measure	Time frame
Main symptom relief time;	—

Secondary

Measure	Time frame
Time to COVID-19 RNA convert negative;Secondary infection occurrence rate;Time to recovery;Severe case occurrence rate;Frequency of antipyretic use;All-Cause Mortality;Adverse effects rate;Other symptoms relief rate & time;Time & Rate of inflammatory biomarkers convert normal;	—

Countries

China

Contacts

Public ContactYe Feng/ Yang Zifeng/ Xu Xuyan/ Zhu Jun/ Jiang Lihong/ Zhang Yunhui/ Yuan Bing/ Chen Shi/ Fan Jie

The First Affiliated Hospital of Guangzhou Medical University

yefeng@gird.cn+86 13710494278; +86 13622273918

Outcome results

None listed

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