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

Not Applicable

Not yet recruiting

• Conditions: COVID-19
• Interventions: Other: Placebo Treatment; Drug: Traditional Chinese Medicine Formulation

• Registration Number: NCT05672498
• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-01
• Study First Submitted: 2023-01-03
• Study First Submitted QC: 2023-01-03
• Study Start: 2023-01-05
• Study First Posted: 2023-01-05
• Last Update Submitted: 2023-01-05
• Last Update Posted: 2023-01-09
• Primary Completion: 2023-04-05
• Study Completion: 2023-05-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo treatment	Placebo Treatment	The patients are treated with placebo. They take 150ml of liquid placebo every morning and evening for 7 days .
TCM treatment	Traditional Chinese Medicine Formulation	The patients are treated with traditional Chinese medicine. They take 150ml of liquid medicine every morning and evening for 7 days.

Primary Outcome Measures

Name	Time	Method
negative Covid-19 test result	in 7 days or after the intervention	negative test result
Disappearance or Improvement of the most common clinical symptoms	in 7 days or after the intervention	such as fever,cough,pharyngalgia

Secondary Outcome Measures

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

Trial Locations

Locations (1)

First Affilicated Hospital of Xian Jiaotong University; 🇨🇳 Xi'an, Shanxi, China