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临床试验/NCT05672498
NCT05672498尚未招募不适用

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

First Affiliated Hospital Xi'an Jiaotong University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年1月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
试验地点
1
主要终点
negative Covid-19 test result

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

TCM treatment

Active Comparator

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

干预措施: Traditional Chinese Medicine Formulation (Drug)

placebo treatment

Placebo Comparator

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

干预措施: Placebo Treatment (Other)

结局指标

主要结局

negative Covid-19 test result

时间窗: in 7 days or after the intervention

negative test result

Disappearance or Improvement of the most common clinical symptoms

时间窗: in 7 days or after the intervention

such as fever,cough,pharyngalgia

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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