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NCT Number: NCT06613659

Cohort Study on the Treatment of Severe Pneumonia with Traditional Chinese Medicine

This is a multicenter, prospective cohort study, with syndrome differentiation and treatment of traditional Chinese medicine as the exposure factor. Patients using syndrome differentiation of traditional Chinese medicine combined with conventional treatment of Western medicine are classified as the treatment cohort of Integrated Chinese and Western medicine, and patients using conventional treatment of Western medicine only are classified as the treatment cohort of Western medicine

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Key information

Conditions

Community-Acquired Infections Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

Zhengzhou, Henan, 450000, China

Location contact

Yang Xie, Doctor

CONTACT

[email protected]

86-371-66248624

About this study

Severe pneumonia is a severe respiratory disease with high mortality, many complications and poor prognosis. Traditional Chinese medicine has certain curative effect in the adjuvant treatment of severe pneumonia, but there is a lack of systematic TCM syndrome differentiation scheme and its curative effect evaluation in the real medical environment. The cohort study on the efficacy of TCM syndrome differentiation scheme in the adjuvant treatment of severe pneumonia is conducive to providing new evidence for the optimization and evidence-based evaluation of TCM treatment scheme for severe pneumonia. Therefore, this study took severe pneumonia as the research object, standardized use of traditional Chinese medicine diagnosis and treatment scheme as the exposure factor, carried out a multi center prospective cohort study, used the 90 day mortality, 28 day mortality, treatment failure rate, etc., to evaluate the clinical efficacy and safety of integrated traditional Chinese and Western medicine in the treatment of severe pneumonia, and provided evidence for the application and promotion of traditional Chinese medicine in severe pneumonia.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • It met the diagnostic criteria of severe pneumonia;
  • Age ≥ 18 years old, regardless of gender.
  • Voluntary treatment.
  • Sign the informed consent form.

Exclusion criteria

  • Pregnant or lactating women;
  • Patients with mental illness who are unable to cooperate or unwilling to cooperate with follow-up;
  • Those who are participating in clinical trials of other drugs;
  • Known allergic to therapeutic drugs.

Treatment and study plan

Traditional Chinese medicine (TCM)

Drug

Taking the use of traditional Chinese medicine syndrome differentiation treatment as the exposure factor, the continuous use of traditional Chinese medicine for 3-5 days was defined as mild exposure, continuous use of traditional Chinese medicine for 6-10 days as moderate exposure, and continuous use of traditional Chinese medicine for more than 10 days as severe exposure. The exposed group used TCM syndrome differentiation therapy combined with conventional western medicine treatment (integrative medicine treatment cohort), and the non exposed group used conventional western medicine treatment without standardized TCM syndrome differentiation treatment (Western medicine treatment cohort). The treatment plan was formulated by the clinician, and the researcher did not intervene.

non traditional Chinese medicine (non-TCM)

Drug

Taking the use of traditional Chinese medicine syndrome differentiation treatment as the exposure factor, the continuous use of traditional Chinese medicine for 3-5 days was defined as mild exposure, continuous use of traditional Chinese medicine for 6-10 days as moderate exposure, and continuous use of traditional Chinese medicine for more than 10 days as severe exposure. The exposed group used TCM syndrome differentiation therapy combined with conventional western medicine treatment (integrative medicine treatment cohort), and the non exposed group used conventional western medicine treatment without standardized TCM syndrome differentiation treatment (Western medicine treatment cohort). The treatment plan was formulated by the clinician, and the researcher did not intervene.

Primary outcomes

  1. 90-day mortality

    Time frame: Mortality on the 90th day of treatment

    Calculate the proportion of patients who died of the disease on the 90th day of treatment

Secondary outcomes

  1. 28-day mortality

    Time frame: Calculate the proportion of patients who died of the disease on the 28th day after discharge

  2. treatment failure rate

    Time frame: Early treatment failure was defined as clinical deterioration within 72 hours of treatment. Late treatment failure between 72 hours and to 28 days.

    The primary efficacy outcome was the rate of treatment failure, which includes treatment failure that occurred early,late, or at both times.

  3. 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.

  4. ICU stay time

    Time frame: the 28 days of the treatment phase.

    length of ICU and hospital stays will be recorded.

  5. hospitalization time

    Time frame: the 28 days of the treatment phase

    length of hospital stays will be recorded.

  6. Mechanical ventilation time

    Time frame: the 28 days of the treatment phase

    Time of invasive mechanical ventilation

  7. SOFA score

    Time frame: The sofa scores of the first, seventh, fourteenth, twenty-first and twenty-eight days of admission and the first, second and third months after discharge 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.

  8. Quality of life

    Time frame: The scores of the first, seventh, fourteenth, twenty-first and twenty-eight days of admission and the first, second and third months after discharge 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.

  9. TCM syndrome score

    Time frame: The TCM syndrome scores of the first, seventh, fourteenth, twenty-first and twenty-eight days and the first, second and third months after discharge 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.

  10. 90 day readmission rate

    Time frame: The proportion of rehospitalization due to exacerbation within 90 days after discharge was recorded

    The proportion of rehospitalization due to exacerbation within 90 days after discharge was recorded

Study contacts

Contact information is provided by the study sponsor or research team.

Haifeng Wang, doctor

CONTACT

[email protected]

86-371-66248624

jiangsheng Li, doctor

CONTACT

[email protected]

86-371-66248624

Sponsors and collaborators

Lead sponsor

Henan University of Traditional Chinese Medicine

Other

Registry information

Official study title

Cohort Study on the Efficacy of Traditional Chinese Medicine Syndrome Differentiation Scheme in Adjuvant Treatment of Severe Pneumonia Based on the Real World

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Sep 26, 2024
Registry last updated
Sep 26, 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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