Integrated Traditional Chinese and Conventional Medicine in Treatment for Patients with Severe COVID-19: Study Protocol for a Randomized Controlled Trial
Overview
- Phase
- Phase 3
- Intervention
- TCM plus conventional drug
- Conditions
- Severe COVID-19
- Sponsor
- Henan University of Traditional Chinese Medicine
- Enrollment
- 172
- Locations
- 1
- Primary Endpoint
- 28-day mortality
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
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.
Arms & Interventions
TCM plus conventional drug
The experimental group will receive three type of TCM inaddition conventional drug
Intervention: TCM plus conventional drug
TCM placebo plus conventional drug
The control group will receive three type of placebo TCM inaddition conventional drug
Intervention: TCM placebo plus conventional drug
Outcomes
Primary Outcomes
28-day mortality
Time Frame: Mortality on the 28th day of treatment
Proportion of patients who died of disease on day 28
Secondary Outcomes
- Days without invasive mechanical ventilation(the 28 days of the treatment phase)
- invasive mechanical ventilation rate(28 days in the treatment phase)
- days of non-ICU(28 days in the treatment phase)
- time to clinical stability(every day in the treatment.)
- hospitalization time(the 28 days of the treatment phase)
- Clinical status of patients 15 days after randomization(The clinical status of patients was observed 15 days after randomization.)
- Quality of life(The scores on the 1st, 4th, 7th, 14th, 21st and 28th day of admission were counted.)
- TCM syndrome score(The scores on the 1st, 4th, 7th, 14th, 21st and 28th day of admission were counted.)
- SOFA score(The scores on the 1st, 4th, 7th, 14th, 21st and 28th day of admission were counted)