Effect of a Traditional Chinese Medicine Formulation on COVID-19 Infection

Study Overview
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Brief Summary
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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.

Official Title
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A Comparative Study on the Therapeutic Effect of a Traditional Chinese Medicine Formulation on COVID-19 Infection

Conditions
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COVID-19

Intervention / Treatment
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* Drug: Traditional Chinese Medicine Formulation
* Other: Placebo Treatment


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TCM treatment<br>The patients are treated with traditional Chinese medicine. They take 150ml of liquid medicine every morning and evening for 7 days. | Drug: Traditional Chinese Medicine Formulation<br>* 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.<br>|
| Placebo Comparator: placebo treatment<br>The patients are treated with placebo. They take 150ml of liquid placebo every morning and evening for 7 days . | Other: Placebo Treatment<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| negative Covid-19 test result | negative test result | in 7 days or after the intervention | 
| Disappearance or Improvement of the most common clinical symptoms | such as fever,cough,pharyngalgia | in 7 days or after the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| erythrocyte sedimentation rate | mm/h | in 7 days or after the intervention | 
| C-reactionprotein | mg/L | in 7 days or after the intervention | 
| Interleukin- 6 | Pg/ml | in 7 days or after the intervention | 
| Procalcitonin | mg/L | in 7 days or after the intervention | 
| Covid-19 antibody concentration | ng/ml | in 7 days or after the intervention | 
| blood fat | mmol/L | in 7 days or after the intervention |