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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHenan University of Traditional Chinese Medicine

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

It met the diagnostic criteria of severe pneumonia;

Age ≥ 18 years old, regardless of gender.

Voluntary treatment.

Sign the informed consent form.

Disqualifiers

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.

Trial population

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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

1,016 Participants
are divided into 2 treatment groups
Group A: Treatment cohort of integrated traditional Chinese and Western Medicine1 intervention
Group B: Western medicine treatment queue1 intervention

Trial outcomes

Primary outcomes

1

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

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

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.
3

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.
4

ICU stay time

length of ICU and hospital stays will be recorded.

Time frame
the 28 days of the treatment phase.

Other outcomes

Sponsors and contacts

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