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Integrated Traditional Chinese and Conventional Medicine in Treatment for Patients with Severe COVID-19: Study Protocol for a Randomized Controlled Trial
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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
Zhengzhou, Henan, China
Start Date
January 29, 2023
Primary Completion Date
November 8, 2023
Completion Date
January 25, 2024
Last Updated
December 3, 2024
172
ACTUAL participants
TCM plus conventional drug
DRUG
TCM placebo plus conventional drug
DRUG
Lead Sponsor
Henan University of Traditional Chinese Medicine
NCT06235866
NCT05254990
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT04745637