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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05672498
• Other study ID #: XJTU1AF2022LSK-436
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 5, 2023
• Est. completion date: May 5, 2023

Study information

• Verified date: January 2023
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: Bingyin Shi
• Phone: 0086-13700298366
• Email: shibingy[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: May 5, 2023
• Est. primary completion date: April 5, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• Traditional Chinese Medicine Formulation
The TCM Treatment Group:The patient are given a traditional Chinese medicine formulation, taking 150 ml of liquid medicine every morning and evening for 7 days.

Other:
• Placebo Treatment
Placebo Treatment Group:The patient are given placebo, taking 150 ml of liquid placebo every morning and evening for 7 days. All medications and placebo are packed identically in packing bags with the same labeling form.

Locations

Country	Name	City	State
China	First Affilicated Hospital of Xian Jiaotong University	Xi'an	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	negative Covid-19 test result	negative test result	in 7 days or after the intervention
Primary	Disappearance or Improvement of the most common clinical symptoms	such as fever,cough,pharyngalgia	in 7 days or after the intervention
Secondary	erythrocyte sedimentation rate	mm/h	in 7 days or after the intervention
Secondary	C-reactionprotein	mg/L	in 7 days or after the intervention
Secondary	Interleukin- 6	Pg/ml	in 7 days or after the intervention
Secondary	Procalcitonin	mg/L	in 7 days or after the intervention
Secondary	Covid-19 antibody concentration	ng/ml	in 7 days or after the intervention
Secondary	blood fat	mmol/L	in 7 days or after the intervention