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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: COVID-19
• Intervention / Treatment: Drug: Traditional Chinese Medicine Formulation; Other: Placebo Treatment

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bingyin Shi; Phone Number: 0086-13700298366; Email: shibingy@126.com
• Study Contact Backup: Name: Zixian Du, master; Phone Number: 0086-15117288251; Email: 379880218@qq.com

Study Locations

• China
  • Shanxi
    • Xi'an, Shanxi, China, 710061
      • First Affilicated Hospital of Xian Jiaotong University
      • Contact: Zixian Du, master; Phone Number: 0086-15117288251; Email: 379880218@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: TCM treatment; The patients are treated with traditional Chinese medicine. They take 150ml of liquid medicine every morning and evening for 7 days.	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.
Placebo Comparator: placebo treatment; The patients are treated with placebo. They take 150ml of liquid placebo 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: First Affiliated Hospital Xi'an Jiaotong University

Study record dates

Study Major Dates

• Study Start (Anticipated): January 5, 2023
• Primary Completion (Anticipated): April 5, 2023
• Study Completion (Anticipated): May 5, 2023

Study Registration Dates

• First Submitted: January 3, 2023
• First Submitted That Met QC Criteria: January 3, 2023
• First Posted (Actual): January 5, 2023

Study Record Updates

• Last Update Posted (Estimate): January 9, 2023
• Last Update Submitted That Met QC Criteria: January 5, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: XJTU1AF2022LSK-436

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No