Clinical trial NCT05672498: 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
Overall status: UNKNOWN
Phase: NA
Conditions: COVID-19
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2023-01-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: negative Covid-19 test result
timeFrame: in 7 days or after the intervention
measure: Disappearance or Improvement of the most common clinical symptoms
timeFrame: in 7 days or after the intervention
Secondary outcomes:
measure: erythrocyte sedimentation rate
timeFrame: in 7 days or after the intervention
measure: C-reactionprotein
timeFrame: in 7 days or after the intervention
measure: Interleukin- 6
timeFrame: in 7 days or after the intervention
measure: Procalcitonin
timeFrame: in 7 days or after the intervention
measure: Covid-19 antibody concentration
timeFrame: in 7 days or after the intervention
measure: blood fat
timeFrame: in 7 days or after the intervention
Other outcomes:
Locations:
city: Xi'an
country: China
facility: First Affilicated Hospital of Xian Jiaotong University
state: Shanxi
Study officials:
affiliation: First Affilicated Hospital of Xian Jiaotong University
name: Bingyin Shi
role: STUDY_CHAIR
References: