NCT06714032

Effect of Traditional Chinese Medicine of Severe COVID-19

Integrated Traditional Chinese and Conventional Medicine in Treatment for Patients with Severe COVID-19: Study Protocol for a Randomized Controlled Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 172 (actual)
• Sponsor: Henan University of Traditional Chinese Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study evaluated the effect of integrated traditional Chinese and Western medicine in the treatment of Severe COVID-19. The patients were randomly divided into experimental group and control group.

Detailed description

In this study, a multi center randomized controlled trial design was adopted, and the subjects were randomly divided into the experimental group and the control group. The control group was treated with western medicine conventional treatment plus traditional Chinese medicine decoction simulant, while the experimental group was treated with traditional Chinese medicine syndrome differentiation treatment decoction. The course of treatment was 14 days and the patients were followed up for 3 months. The clinical effect of integrated traditional Chinese and Western medicine treatment was evaluated from the aspects of 28 day mortality, 28 days without invasive mechanical ventilation, invasive mechanical ventilation rate, 28 days without ICU stay, clinical stability time, length of hospital stay, quality of life, SOFA score, etc., to clarify the clinical efficacy of integrated traditional Chinese and Western medicine treatment for Severe COVID-19 infection.

Conditions

• Severe COVID-19

Interventions

Type	Name	Description
DRUG	TCM plus conventional drug	All patients were treated according to international guidelines. The Experimental group will receive TCM according to the TCM syndrome.
DRUG	TCM placebo plus conventional drug	All patients were treated according to international guidelines. The control group will receive TCM placebo according to the TCM syndrome.

Timeline

• Start date: 2023-01-29
• Primary completion: 2023-11-08
• Completion: 2024-01-25
• First posted: 2024-12-03
• Last updated: 2024-12-03

Locations

1 site across 1 country: China