Back to resultsCOVID-19 Huashi Baidu Formula Clinical Study
Primary Purpose
COVID-19
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Huashi Baidu Granule
Monapiravir
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19 focused on measuring Huashi Baidu Granule, Randomized controlled trial, Evidence-based
Eligibility Criteria
Inclusion Criteria: 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) ； Age ≥ 18 years and ≤ 65 years; The time from the first symptom (or confirmed onset) shall not exceed 5 days; 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: 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. Patients with severe primary respiratory diseases or other pathogenic microorganism pneumonia that needs to be differentiated from COVID-19. Pregnant women, with positive urine pregnancy test, or with pregnancy plan within 12 months. Patients suffering from malignant tumors, mental diseases and other systematic malignant diseases that the researchers consider unsuitable for the study. People who have ever been allergic to the test drug and who do not tolerate the drug. Those who are participating in other clinical trials. Non severe patients in the trial shall not enter the study again after changing the classification.
Sites / Locations
- Beijing You'an Hospital, Capital Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Treatment group
Control group
Arm Description
Huashi Baidu Granule+Monapiravir simulant
Monapiravir+Huashi Baidu Granule Simulator
Outcomes
Primary Outcome Measures
Nucleic acid negative rate in 5 days;Virus CT value
Quantitative standard of viral CT value for nucleic acid detection： According to the Technical guidelines for laboratory testing of novel coronavirus, the Ct value of nucleic acid testing of novel coronavirus is less than 37, which can be reported is positive; No Ct value or Ct value greater than 40 was negative. If the Ct value was between 37 and 40, it is recommended to repeat the experiment. If Ct If the value is less than 40, the amplification curve has obvious peak, and the sample is judged as positive, otherwise it is negative.
Secondary Outcome Measures
Disease score
Therapeutic efficacy evaluation scale of traditional Chinese medicine in treating COVID-19
Score of individual symptom
fever, asthenia, cough, dyspnea, generalized aches and pains, abnormal taste and smell, diarrhea, nasal congestion, runny nose and headache
TCM symptom score
Quantitative table of TCM syndrome score of novel coronavirus pneumonia
Hematological parameters
C-reactive protein, erythrocyte sedimentation rate, lymphocyte count, lymphocyte/neutrophil ratio, coagulation, D-Di and IL-6
Symptom relief rate
Time when symptom disappears
Rate of progression to severe COVID-19 cases
Refer to the severe diagnostic criteria for COVID-19 issued by the National Health Commission and the National Administration of Traditional Chinese Medicine: Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia (Trial Version 10)
Full Information
NCT ID
NCT05638672
First Posted
December 5, 2022
Last Updated
May 13, 2023
Sponsor
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Collaborators
Beijing YouAn Hospital, Kossamak Hospital, Kamuzu University of Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT05638672
Brief Title
COVID-19 Huashi Baidu Formula Clinical Study
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.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 6, 2023 (Actual)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Collaborators
Beijing YouAn Hospital, Kossamak Hospital, Kamuzu University of Health Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Combined with the regional and population characteristics of Asia and Africa, Huashi Baidu Granule was used to intervene in mild and moderate patients with COVID-19, evaluate its 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
Huashi Baidu Granule, Randomized controlled trial, Evidence-based
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment group
Arm Type
Experimental
Arm Description
Huashi Baidu Granule+Monapiravir simulant
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Monapiravir+Huashi Baidu Granule Simulator
Intervention Type
Drug
Intervention Name(s)
Huashi Baidu Granule
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Monapiravir
Intervention Description
Monapiravir, manufactured by Merck, an American pharmaceutical company, with the specification of 200mg × 40 capsules, 800mg each time, twice a day.
Primary Outcome Measure Information:
Title
Nucleic acid negative rate in 5 days;Virus CT value
Description
Quantitative standard of viral CT value for nucleic acid detection： According to the Technical guidelines for laboratory testing of novel coronavirus, the Ct value of nucleic acid testing of novel coronavirus is less than 37, which can be reported is positive; No Ct value or Ct value greater than 40 was negative. If the Ct value was between 37 and 40, it is recommended to repeat the experiment. If Ct If the value is less than 40, the amplification curve has obvious peak, and the sample is judged as positive, otherwise it is negative.
Time Frame
The treatment period，Receive the test by PCR once a daily ，for 5 consecutive days
Secondary Outcome Measure Information:
Title
Disease score
Description
Therapeutic efficacy evaluation scale of traditional Chinese medicine in treating COVID-19
Time Frame
The treatment period, including 5 days after administration, and the follow-up period, which is day 11, day 21, and day 30 after administration, respectively
Title
Score of individual symptom
Description
fever, asthenia, cough, dyspnea, generalized aches and pains, abnormal taste and smell, diarrhea, nasal congestion, runny nose and headache
Time Frame
The treatment period, including 5 days after administration, and the follow-up period, which is day 11, day 21, and day 30 after administration, respectively
Title
TCM symptom score
Description
Quantitative table of TCM syndrome score of novel coronavirus pneumonia
Time Frame
The treatment period, including 5 days after administration, and the follow-up period, which is day 11, day 21, and day 30 after administration, respectively
Title
Hematological parameters
Description
C-reactive protein, erythrocyte sedimentation rate, lymphocyte count, lymphocyte/neutrophil ratio, coagulation, D-Di and IL-6
Time Frame
The treatment period, day one and day five after administration
Title
Symptom relief rate
Description
Time when symptom disappears
Time Frame
30days
Title
Rate of progression to severe COVID-19 cases
Description
Refer to the severe diagnostic criteria for COVID-19 issued by the National Health Commission and the National Administration of Traditional Chinese Medicine: Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia (Trial Version 10)
Time Frame
30days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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) ；
Age ≥ 18 years and ≤ 65 years;
The time from the first symptom (or confirmed onset) shall not exceed 5 days;
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:
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.
Patients with severe primary respiratory diseases or other pathogenic microorganism pneumonia that needs to be differentiated from COVID-19.
Pregnant women, with positive urine pregnancy test, or with pregnancy plan within 12 months.
Patients suffering from malignant tumors, mental diseases and other systematic malignant diseases that the researchers consider unsuitable for the study.
People who have ever been allergic to the test drug and who do not tolerate the drug.
Those who are participating in other clinical trials.
Non severe patients in the trial shall not enter the study again after changing the classification.
Facility Information:
Facility Name
Beijing You'an Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100069
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhongjie Hu
Phone
010-83997191
Email
youanyuanban@163.com
12. IPD Sharing Statement
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COVID-19 Huashi Baidu Formula Clinical Study
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