NCT06613659

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

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,016 (estimated)
• Sponsor: Henan University of Traditional Chinese Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Community-Acquired Infections

Interventions

Type	Name	Description
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 (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.
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.

Timeline

• Start date: 2024-09-20
• Primary completion: 2027-04-30
• Completion: 2027-10-30
• First posted: 2024-09-26
• Last updated: 2024-09-26

Locations

1 site across 1 country: China