Effect of Traditional Chinese Medicine of Severe COVID-19

Phase 3

Completed

• Conditions: Severe COVID-19
• Interventions: Drug: TCM placebo plus conventional drug; Drug: TCM plus conventional drug

• Registration Number: NCT06714032
• Lead Sponsor: Henan University of Traditional Chinese Medicine

Brief 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.

Study Timeline

• Study Start: 2023-01-29
• Primary Completion: 2023-11-08
• Study Completion: 2024-01-25
• Study First Submitted: 2024-10-26
• Status Verified: 2024-12
• Study First Submitted QC: 2024-12-02
• Last Update Submitted: 2024-12-02
• Study First Posted: 2024-12-03
• Last Update Posted: 2024-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 172

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TCM placebo plus conventional drug	TCM placebo plus conventional drug	The control group will receive three type of placebo TCM inaddition conventional drug
TCM plus conventional drug	TCM plus conventional drug	The experimental group will receive three type of TCM inaddition conventional drug

Primary Outcome Measures

Name	Time	Method
28-day mortality	Mortality on the 28th day of treatment	Proportion of patients who died of disease on day 28

Secondary Outcome Measures

Name	Time	Method
Quality of life	The scores on the 1st, 4th, 7th, 14th, 21st and 28th day of admission were counted.	Score according to the quality of life table,the minimum score is 12 points, and the maximum score is 60 points. The higher the score, the worse the result.
Days without invasive mechanical ventilation	the 28 days of the treatment phase	Days without invasive mechanical ventilation in 28 days
invasive mechanical ventilation rate	28 days in the treatment phase	Rate of patients receiving invasive mechanical ventilation
days of non-ICU	28 days in the treatment phase	Calculate the number of days of patients not staying in ICU within 28 days
time to clinical stability	every day in the treatment.	temperature of 37.2°C orlower, heart rate of 100 beats/min or lower, systolic blood pressure of 90 mm Hg or higher, and arterial oxygen tension of 60 mm Hg or higher when the patient was not receiving supplemental oxygen.
hospitalization time	the 28 days of the treatment phase	length of hospital stays will be recorded.
Clinical status of patients 15 days after randomization	The clinical status of patients was observed 15 days after randomization.	According to the 6-point clinical improvement scale of the World Health Organization, the lowest score was 1 and the highest was 6. The higher the score, the worse the result.
TCM syndrome score	The scores on the 1st, 4th, 7th, 14th, 21st and 28th day of admission were counted.	Traditional Chinese Medicine Syndrome Points.Including cough, expectoration, dyspnea, chest pain, anorexia and fatigue, each item is rated as 1-5 points from mild to severe.The minimum score is 6 points and the maximum score is 30 points. The higher the score, the worse the result.
SOFA score	The scores on the 1st, 4th, 7th, 14th, 21st and 28th day of admission were counted	Sequential Organ Failure Assessment.It is a scoring system for evaluating and monitoring the organ function of critically ill patients.The minimum score is 0 and the maximum is 24. The higher the score, the worse the result.

Trial Locations

Locations (1)

The First Affiliated Hospital of Henan University of Traditional Chinese Medicine; 🇨🇳 Zhengzhou, Henan, China