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Clinical Trials/NCT05672498
NCT05672498
Not yet recruiting
Not Applicable

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

First Affiliated Hospital Xi'an Jiaotong University1 site in 1 country100 target enrollmentJanuary 5, 2023

Overview

Phase
Not Applicable
Intervention
Traditional Chinese Medicine Formulation
Conditions
COVID-19
Sponsor
First Affiliated Hospital Xi'an Jiaotong University
Enrollment
100
Locations
1
Primary Endpoint
negative Covid-19 test result
Status
Not yet recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 5, 2023
End Date
May 5, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

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.

Arms & Interventions

TCM treatment

The patients are treated with traditional Chinese medicine. They take 150ml of liquid medicine every morning and evening for 7 days.

Intervention: Traditional Chinese Medicine Formulation

placebo treatment

The patients are treated with placebo. They take 150ml of liquid placebo every morning and evening for 7 days .

Intervention: Placebo Treatment

Outcomes

Primary Outcomes

negative Covid-19 test result

Time Frame: in 7 days or after the intervention

negative test result

Disappearance or Improvement of the most common clinical symptoms

Time Frame: in 7 days or after the intervention

such as fever,cough,pharyngalgia

Secondary Outcomes

  • C-reactionprotein(in 7 days or after the intervention)
  • Interleukin- 6(in 7 days or after the intervention)
  • Procalcitonin(in 7 days or after the intervention)
  • erythrocyte sedimentation rate(in 7 days or after the intervention)
  • Covid-19 antibody concentration(in 7 days or after the intervention)
  • blood fat(in 7 days or after the intervention)

Study Sites (1)

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