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

NCT06613659 | Not Yet Recruiting

• 1 other identifier: RESEARCH-SEVERE PNEUMONIA
• Study Type: observational
• Target: 1,016
• Locations: 1 country
• Sites: 1

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

Conditions

Community-Acquired Infections

Keywords

Community-Acquired Infections; Traditional Chinese Medicine; Cohort study

Outcome Measures

Primary Outcomes (1)

• 90-day mortality

  Calculate the proportion of patients who died of the disease on the 90th day of treatment

  Mortality on the 90th day of treatment

Secondary Outcomes (10)

• 28-day mortality

  Calculate the proportion of patients who died of the disease on the 28th day after discharge

• treatment failure rate

  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

  every day in the treatment.

• ICU stay time

  the 28 days of the treatment phase.

• hospitalization time

  the 28 days of the treatment phase

Study Arms (2)

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).

Drug: traditional Chinese medicine (TCM)

Western medicine treatment queue

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)

Interventions

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.

Treatment cohort of integrated traditional Chinese and Western Medicine

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.

Western medicine treatment queue

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study 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.

You may qualify if:

• It met the diagnostic criteria of severe pneumonia;
• Age ≥ 18 years old, regardless of gender.
• Voluntary treatment.
• Sign the informed consent form.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Henan University of Traditional Chinese Medicine: lead

Study Sites (1)

The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

Zhengzhou, Henan, 450000, China

Location

MeSH Terms

Conditions

Community-Acquired Infections

Interventions

Medicine, Chinese Traditional

Condition Hierarchy (Ancestors)

Infections

Intervention Hierarchy (Ancestors)

Medicine, East Asian Traditional; Medicine, Traditional; Complementary Therapies; Therapeutics

Central Study Contacts

Haifeng Wang, doctor

CONTACT

86-371-66248624; wangh_f@126.com

jiangsheng Li, doctor

CONTACT

86-371-66248624; li_js8@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2024
• First Posted: September 26, 2024
• Study Start: September 20, 2024
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): October 30, 2027
• Last Updated: September 26, 2024

Record last verified: 2023-11

Locations

CN (1)