Effect of Traditional Chinese Medicine of Severe COVID-19

Henan University of Traditional Chinese Medicine

Status and phase

Completed

Phase 3

Conditions

Severe COVID-19

Treatments

Drug: TCM plus conventional drug

Drug: TCM placebo plus conventional drug

Study type

Interventional

Funder types

Other

Identifiers

NCT06714032

TCM for Severe COVID-19

Details and patient eligibility

About

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.

Full 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.

Enrollment

172 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

accord with the diagnosis of severe/critical novel coronavirus infection;
Age > 18 years old;
TCM syndrome differentiation diagnosis by the attending physician or above or two attending physicians for diagnosis and consensus;
Sign the informed consent form.

Exclusion criteria

Pregnant and lactating women;
Trauma, hematological malignancies, various solid tumors and obstetric complications;
Dementia, various mental patients and those who are unwilling to cooperate;
The patient is expected to die within the next 24 hours;
Combined with neuromuscular diseases affecting respiratory and motor functions;
people who have been bedridden for a long time for various reasons;
Clinical trial participants who are taking part in other intervention measures;
Those who are known to be allergic to the therapeutic drugs in this study.