Clinical trial NCT06714032: Effect of Traditional Chinese Medicine of Severe COVID-19
Official title: Integrated Traditional Chinese and Conventional Medicine in Treatment for Patients with Severe COVID-19: Study Protocol for a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Severe COVID-19
Keywords: Traditional Chinese Medicine
Severe COVID-19
Lead sponsor: Henan University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2024-12-03
Enrollment: 172
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 28-day mortality
timeFrame: Mortality on the 28th day of treatment
Secondary outcomes:
measure: Days without invasive mechanical ventilation
timeFrame: the 28 days of the treatment phase
measure: invasive mechanical ventilation rate
timeFrame: 28 days in the treatment phase
measure: days of non-ICU
timeFrame: 28 days in the treatment phase
measure: time to clinical stability
timeFrame: every day in the treatment.
measure: hospitalization time
timeFrame: the 28 days of the treatment phase
measure: Clinical status of patients 15 days after randomization
timeFrame: The clinical status of patients was observed 15 days after randomization.
measure: Quality of life
timeFrame: The scores on the 1st, 4th, 7th, 14th, 21st and 28th day of admission were counted.
measure: TCM syndrome score
timeFrame: The scores on the 1st, 4th, 7th, 14th, 21st and 28th day of admission were counted.
measure: SOFA score
timeFrame: The scores on the 1st, 4th, 7th, 14th, 21st and 28th day of admission were counted
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
state: Henan
Study officials:
References: