An observational study in Community-Acquired Infections, sponsored by Henan University of Traditional Chinese Medicine. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-26.
Sponsored by Henan University of Traditional Chinese Medicine · Observational
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
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.
37 studies on the registry are indexed under Community-Acquired Infections; 5 are open to participants now.
This study's planned enrollment of 1,016 is close to the median of 1,009 across 16 observational studies indexed under Community-Acquired Infections.
Browse Community-Acquired Infections studies →Henan University of Traditional Chinese Medicine is the lead sponsor of 55 studies on the registry; 31 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Severe community-acquired pneumonia (CAP) is a severe respiratory disease with further development and deterioration of lung tissue inflammation, causing organ dysfunction and even life-threatening. Patients with SCAP are prone to hypoxemia, respiratory failure, septic shock, leading to multiple organ failure and poor prognosis. Western medicine treatment of SCAP mainly focuses on anti infection and mechanical ventilation. Although new intervention measures and management concepts are constantly optimized, the mortality rate of SCAP is still high. The treatment of SCAP is facing a severe situation, so it is necessary to seek new adjuvant therapy.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 exposure group was treated with syndrome differentiation of traditional Chinese medicine combined with conventional Western Medicine (treatment cohort of integrated traditional Chinese and Western Medicine).
Drug: traditional Chinese medicine (TCM)
The non exposure group (Western medicine treatment cohort) used conventional western medicine treatment but not standardized TCM syndrome differentiation treatment.
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 (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.
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.
90-day mortality
Calculate the proportion of patients who died of the disease on the 90th day of treatment
Time frame: Mortality on the 90th day of treatment
28-day mortality
Time frame: Calculate the proportion of patients who died of the disease on the 28th day after discharge
treatment failure rate
The primary efficacy outcome was the rate of treatment failure, which includes treatment failure that occurred early,late, or at both times.
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
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.
Time frame: every day in the treatment.
ICU stay time
length of ICU and hospital stays will be recorded.
Time frame: the 28 days of the treatment phase.
hospitalization time
length of hospital stays will be recorded.
Time frame: the 28 days of the treatment phase
Mechanical ventilation time
Time of invasive mechanical ventilation
Time frame: the 28 days of the treatment phase
SOFA score
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.
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
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.
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
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.
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
The proportion of rehospitalization due to exacerbation within 90 days after discharge was recorded
Time frame: The proportion of rehospitalization due to exacerbation within 90 days after discharge was recorded
Start is estimated for Sep 2024; primary completion for Apr 2027, 31 months later.
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This study is not yet recruiting, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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Community-Acquired Infections →
Henan University of Traditional Chinese Medicine