Cohort Study on the Treatment of Severe Pneumonia with Traditional Chinese Medicine
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: traditional Chinese medicine (TCM), non traditional Chinese medicine (non-TCM).
- Who it may be relevant to
- Registry conditions: Community-Acquired Infections. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Cohort Study on the Efficacy of Traditional Chinese Medicine Syndrome Differentiation Scheme in Adjuvant Treatment of Severe Pneumonia Based on the Real World
Overview
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
Detailed description
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.
Interventions
- Drug traditional Chinese medicine (TCM)
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 (integrati - Drug non traditional Chinese medicine (non-TCM)
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 (integrati
Primary outcome measures
- 90-day mortality [Time frame: Mortality on the 90th day of treatment]
Secondary outcome measures (10)
- 28-day mortality [Time frame: Calculate the proportion of patients who died of the disease on the 28th day after discharge]
- 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.]
- time to clinical stability [Time frame: every day in the treatment.]
- ICU stay time [Time frame: the 28 days of the treatment phase.]
- hospitalization time [Time frame: the 28 days of the treatment phase]
- Mechanical ventilation time [Time frame: the 28 days of the treatment phase]
- 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.]
- 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]
- 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]
- 90 day readmission rate [Time frame: The proportion of rehospitalization due to exacerbation within 90 days after discharge was recorded]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- The First Affiliated Hospital of Henan University of Traditional Chinese Medicine — Zhengzhou
Identifiers
NCT: NCT06613659 · RESEARCH-SEVERE PNEUMONIA