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Completed

NCT Number: NCT06714032

Effect of Traditional Chinese Medicine of Severe COVID-19

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

Zhengzhou, Henan, 450000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TCM plus conventional drug

Drug

All patients were treated according to international guidelines. The Experimental group will receive TCM according to the TCM syndrome.

TCM placebo plus conventional drug

Drug

All patients were treated according to international guidelines. The control group will receive TCM placebo according to the TCM syndrome.

Primary outcomes

  1. 28-day mortality

    Time frame: Mortality on the 28th day of treatment

    Proportion of patients who died of disease on day 28

Secondary outcomes

  1. Days without invasive mechanical ventilation

    Time frame: the 28 days of the treatment phase

    Days without invasive mechanical ventilation in 28 days

  2. invasive mechanical ventilation rate

    Time frame: 28 days in the treatment phase

    Rate of patients receiving invasive mechanical ventilation

  3. days of non-ICU

    Time frame: 28 days in the treatment phase

    Calculate the number of days of patients not staying in ICU within 28 days

  4. time to clinical stability

    Time frame: 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.

  5. hospitalization time

    Time frame: the 28 days of the treatment phase

    length of hospital stays will be recorded.

  6. Clinical status of patients 15 days after randomization

    Time frame: 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.

  7. Quality of life

    Time frame: 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.

  8. TCM syndrome score

    Time frame: 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.

  9. SOFA score

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Henan University of Traditional Chinese Medicine

Other

Registry information

Official study title

Integrated Traditional Chinese and Conventional Medicine in Treatment for Patients with Severe COVID-19: Study Protocol for a Randomized Controlled Trial

Acronym: COVID-19

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Dec 3, 2024
Registry last updated
Dec 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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