Back to resultsEffect of a Traditional Chinese Medicine Formulation on COVID-19 Infection
Primary Purpose
COVID-19
Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Traditional Chinese Medicine Formulation
Placebo Treatment
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19
Eligibility Criteria
Inclusion Criteria: In the past two to three days, COVID-19 test was positive, accompanied by more than one clinical symptom. 18 ≤ age ≤ 65, regardless of gender; Patients have good follow-up compliance. Exclusion Criteria: Human immunodeficiency virus - 1 infection and malignant tumors; Active cardiovascular, kidney, lung, liver, blood, digestive, neurological or psychiatric diseases; Recent acute respiratory symptoms (within 4 weeks) . Any drug that may interfere with the evaluation (for example, other herbal products such as Lianhua Qingwen, immunosuppressants, anticoagulants), or a history of allergy or other adverse reactions to traditional Chinese medicine products. Pregnant or lactating women. Allergic constitution and allergy to multiple drugs. According to the judgment of the investigator, the subject suffers from any disease that may endanger his safety or affect his compliance with the protocol, or other conditions that are not suitable for the study.
Sites / Locations
- First Affilicated Hospital of Xian Jiaotong University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
TCM treatment
placebo treatment
Arm Description
The patients are treated with traditional Chinese medicine. They take 150ml of liquid medicine every morning and evening for 7 days.
The patients are treated with placebo. They take 150ml of liquid placebo every morning and evening for 7 days .
Outcomes
Primary Outcome Measures
negative Covid-19 test result
negative test result
Disappearance or Improvement of the most common clinical symptoms
such as fever,cough,pharyngalgia
Secondary Outcome Measures
erythrocyte sedimentation rate
mm/h
C-reactionprotein
mg/L
Interleukin- 6
Pg/ml
Procalcitonin
mg/L
Covid-19 antibody concentration
ng/ml
blood fat
mmol/L
Full Information
NCT ID
NCT05672498
First Posted
January 3, 2023
Last Updated
January 5, 2023
Sponsor
First Affiliated Hospital Xi'an Jiaotong University
1. Study Identification
Unique Protocol Identification Number
NCT05672498
Brief Title
Effect of a Traditional Chinese Medicine Formulation on COVID-19 Infection
Official Title
A Comparative Study on the Therapeutic Effect of a Traditional Chinese Medicine Formulation on COVID-19 Infection
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 5, 2023 (Anticipated)
Primary Completion Date
April 5, 2023 (Anticipated)
Study Completion Date
May 5, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First Affiliated Hospital Xi'an Jiaotong University
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
Traditional Chinese medicine (TCM) has been handed down for thousands of years. It has a long history in the treatment of virus infection and has a good effect on the upper respiratory tract infection.
In recent years, the project applicant has been conducting research on the anti infection and anti inflammation treatment of traditional Chinese medicine, and has carried out a lot of clinical practice exploration in non-specific inflammation.
The purpose of this research is to study the therapeutic effect of a traditional Chinese medicine prescription on COVID-19 infection.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TCM treatment
Arm Type
Active Comparator
Arm Description
The patients are treated with traditional Chinese medicine. They take 150ml of liquid medicine every morning and evening for 7 days.
Arm Title
placebo treatment
Arm Type
Placebo Comparator
Arm Description
The patients are treated with placebo. They take 150ml of liquid placebo every morning and evening for 7 days .
Intervention Type
Drug
Intervention Name(s)
Traditional Chinese Medicine Formulation
Intervention Description
The TCM Treatment Group：The patient are given a traditional Chinese medicine formulation, taking 150 ml of liquid medicine every morning and evening for 7 days.
Intervention Type
Other
Intervention Name(s)
Placebo Treatment
Intervention Description
Placebo Treatment Group:The patient are given placebo, taking 150 ml of liquid placebo every morning and evening for 7 days. All medications and placebo are packed identically in packing bags with the same labeling form.
Primary Outcome Measure Information:
Title
negative Covid-19 test result
Description
negative test result
Time Frame
in 7 days or after the intervention
Title
Disappearance or Improvement of the most common clinical symptoms
Description
such as fever,cough,pharyngalgia
Time Frame
in 7 days or after the intervention
Secondary Outcome Measure Information:
Title
erythrocyte sedimentation rate
Description
mm/h
Time Frame
in 7 days or after the intervention
Title
C-reactionprotein
Description
mg/L
Time Frame
in 7 days or after the intervention
Title
Interleukin- 6
Description
Pg/ml
Time Frame
in 7 days or after the intervention
Title
Procalcitonin
Description
mg/L
Time Frame
in 7 days or after the intervention
Title
Covid-19 antibody concentration
Description
ng/ml
Time Frame
in 7 days or after the intervention
Title
blood fat
Description
mmol/L
Time Frame
in 7 days or after the intervention
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:
In the past two to three days, COVID-19 test was positive, accompanied by more than one clinical symptom.
18 ≤ age ≤ 65, regardless of gender;
Patients have good follow-up compliance.
Exclusion Criteria:
Human immunodeficiency virus - 1 infection and malignant tumors; Active cardiovascular, kidney, lung, liver, blood, digestive, neurological or psychiatric diseases; Recent acute respiratory symptoms (within 4 weeks) .
Any drug that may interfere with the evaluation (for example, other herbal products such as Lianhua Qingwen, immunosuppressants, anticoagulants), or a history of allergy or other adverse reactions to traditional Chinese medicine products.
Pregnant or lactating women.
Allergic constitution and allergy to multiple drugs.
According to the judgment of the investigator, the subject suffers from any disease that may endanger his safety or affect his compliance with the protocol, or other conditions that are not suitable for the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bingyin Shi
Phone
0086-13700298366
Email
shibingy@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zixian Du, master
Phone
0086-15117288251
Email
379880218@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bingyin Shi
Organizational Affiliation
First Affilicated Hospital of Xian Jiaotong University
Official's Role
Study Chair
Facility Information:
Facility Name
First Affilicated Hospital of Xian Jiaotong University
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710061
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zixian Du, master
Phone
0086-15117288251
Email
379880218@qq.com
12. IPD Sharing Statement
Learn more about this trial
Effect of a Traditional Chinese Medicine Formulation on COVID-19 Infection
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