Official Title
A Multicenter, Double-blind, Double-dummy, Randomized, Parallel-controlled Clinical Study Evaluating Huashi Baidu Formula in the Treatment of Mild and Moderate Types of COVID-19 Disease.
Brief Summary

Combined with the regional and population characteristics of Asia and Africa, HuashiBaidu Granule was used to intervene in mild and moderate patients with COVID-19, evaluateits efficacy and safety, and clarify its characteristics of action.

Detailed Description

In this study, a double-blind, double dummy, randomized control method was used to
include 300 cases of mild and moderate COVID-19 patients in three centers at home and
abroad. The clinical efficacy of Huashi Baidu Granule and Monapiravir in intervening
COVID-19 patients was compared, It is proved that Huashi Baidu Granule has the same
clinical efficacy and safety against COVID-19 as Monapiravir, and its characteristics of
action are clarified to obtain high-level clinical evidence-based medical evidence of
Huashi Baidu Granule in treating COVID-19 mild and moderate.

Unknown status
COVID-19

Drug: Huashi Baidu Granule

Granule is produced by Guangdong Yifang Pharmaceutical Co., Ltd. with a specification of
5g × 12 bags, twice a day, take 2 sachets each time with boiling water.

Drug: Monapiravir

Monapiravir, manufactured by Merck, an American pharmaceutical company, with the
specification of 200mg × 40 capsules, 800mg each time, twice a day.

Eligibility Criteria

Inclusion Criteria:

1. Conform to the diagnostic criteria for COVID-19 mild and moderate in the Guidelines
for the Diagnosis and Treatment of Novel Coronavirus (COVID-19) Infection (Trial
Version 10) ;

2. Age ≥ 18 years and ≤ 65 years;

3. The time from the first symptom (or confirmed onset) shall not exceed 5 days;

4. If the patient agrees to participate in the study, he/she will sign the informed
consent form through paper signature, electronic signature of mobile software or
voice authorization.

Exclusion Criteria:

1. Patients who cannot guarantee the compliance of taking medicine during the treatment
period, and who are difficult to take medicine by oral or nasal feeding.

2. Patients with severe primary respiratory diseases or other pathogenic microorganism
pneumonia that needs to be differentiated from COVID-19.

3. Pregnant women, with positive urine pregnancy test, or with pregnancy plan within 12
months.

4. Patients suffering from malignant tumors, mental diseases and other systematic
malignant diseases that the researchers consider unsuitable for the study.

5. People who have ever been allergic to the test drug and who do not tolerate the
drug.

6. Those who are participating in other clinical trials.

7. Non severe patients in the trial shall not enter the study again after changing the
classification.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 65 Years
Countries
China
Locations

Beijing You'an Hospital, Capital Medical University
Beijing, Beijing, China

Investigator: Zhongjie Hu
Contact: 010-83997191
youanyuanban@163.com

Not Provided

Xiyuan Hospital of China Academy of Chinese Medical Sciences
NCT Number
Keywords
Huashi Baidu Granule
randomized controlled trial
Evidence-based
MeSH Terms
COVID-19