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

NCT ID: NCT06613659

Last Updated: 2024-09-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 1016 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-09-20
• Study Completion Date: 2027-10-30

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Treatment cohort of integrated traditional Chinese and Western Medicine

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).

traditional Chinese medicine (TCM)

Intervention Type: 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.

Western medicine treatment queue

The non exposure group (Western medicine treatment cohort) used conventional western medicine treatment but not standardized TCM syndrome differentiation treatment.

non traditional Chinese medicine (non-TCM)

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Henan University of Traditional Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

Zhengzhou, Henan, China

Countries

China

Central Contacts

Haifeng Wang, doctor

Role: CONTACT

wangh_f@126.com

86-371-66248624

jiangsheng Li, doctor

Role: CONTACT

li_js8@163.com

86-371-66248624

Facility Contacts

Yang Xie, Doctor

Role: primary

xieyanghn@163.com

86-371-66248624

Other Identifiers

RESEARCH-SEVERE PNEUMONIA

Identifier Type: -

Identifier Source: org_study_id