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

Xi'an Jiaotong University

Status: Not yet enrolling

Conditions: COVID-19

Treatments: Drug: Traditional Chinese Medicine Formulation; Other: Placebo Treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT05672498

XJTU1AF2022LSK-436

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups, including a placebo group

TCM treatment

Active Comparator group

Description:

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

Treatment:

Drug: Traditional Chinese Medicine Formulation

placebo treatment

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo Treatment