Clinical trial NCT06747325: Clinical Trial of Fei Re Qing Granules in the Treatment of Elderly Community-Acquired Pneumonia
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Fei Re Qing Granules in the Treatment of Elderly Community-Acquired Pneumonia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Community-Acquired Pneumonia (CAP)
Keywords: elderly community-acquired pneumonia (CAP)
traditional Chinese medicine
randomized controlled trial
Fei Re Qing Granules
Lead sponsor: Henan University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Third Affiliated Hospital of Henan University of Traditional Chinese Medicine
name: The First Affiliated Hospital of Henan university of CM
First posted: 2024-12-24
Enrollment: 120
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the clinical efficacy of traditional Chinese medicine formula granules (Fei Re Qing Granules) in the treatment of elderly community-acquired pneumonia, establish a treatment protocol, and obtain high-level clinical evidence.

Detailed description: This study evaluates the efficacy and safety of Fei Re Qing Granules for elderly community-acquired pneumonia (CAP) through a multicenter, randomized, double-blind, placebo-controlled trial.

Key elements of the trial include:

Design: Conducted across multiple centers, comparing treatment and placebo groups.

Participants: Patients aged 65-80 years diagnosed with CAP according to both Western and Traditional Chinese Medicine (TCM) diagnostic criteria.

Intervention:

Test group: Fei Re Qing Granules administered alongside standard CAP treatments.

Control group: Placebo granules matching the appearance and composition of the active granules, plus standard treatments.

Outcomes:

Primary efficacy indicator: Time to clinical stability. Secondary indicators: Symptom improvement, hospital stay length, and imaging-based inflammation resolution.

TCM-specific indicators assess syndrome improvements and integrate modern scoring methods (e.g., CURB-65).

Study Duration: Two 7-day treatment cycles with 12-week follow-ups. This trial seeks to establish robust evidence for integrating Fei Re Qing Granules into TCM-based CAP management strategies

Eligibility criteria: Inclusion Criteria:

* Inpatients diagnosed with community-acquired pneumonia (CAP) according to the diagnostic criteria.
* Diagnosed with Phlegm-Heat Obstructing the Lungs syndrome based on Traditional Chinese Medicine (TCM).
* Aged ≥65 and ≤80 years, regardless of gender.
* Onset of illness within 72 hours.
* Clinical symptoms must include at least two of the following four primary。symptoms: cough, sputum production, dyspnea, and pleuritic chest pain.
* Voluntary participation and signed informed consent.

Exclusion Criteria:

* Patients with altered mental status, consciousness disorders, dementia, or psychiatric disorders.
* Patients requiring invasive mechanical ventilation or endotracheal intubation.
* Patients with conditions such as pleural effusion, bronchiectasis, active pulmonary tuberculosis, pulmonary abscess, lung cancer, asthma, or chronic obstructive pulmonary disease (COPD).
* Patients with neuromuscular diseases or those bedridden for long periods, posing a risk of aspiration.
* Patients with cancer, severe cardiovascular diseases (acute myocardial infarction, heart failure stage III or above), or severe liver and kidney diseases (e.g., cirrhosis, portal hypertension with variceal bleeding, dialysis, or kidney transplantation).
* Patients participating in other drug clinical trials or known to be allergic to the study medication.

Primary outcomes:
measure: Time to Clinical Stability
timeFrame: From the start of treatment, the time is recorded until the patient reaches clinical stability, whichever came first, assessed up to 2 weeks.
Secondary outcomes:
measure: Improvement of Clinical Symptoms
timeFrame: Evaluations will be conducted on Day 0, Day 4, Day 7, Day 14 (or at discharge) and during follow-up at 4 weeks and 12 weeks.
measure: Length of Hospital Stay
timeFrame: From the start of treatment, the time is recorded until the patient discharge, whichever came first, assessed up to 2 weeks.
measure: Confusion, Urea, Respiratory rate, Blood pressure, and Age ≥65 Score (CURB-65 score).
timeFrame: The CURB-65 score is assessed on Day 0, Day 4, Day 7, Day 14 (or at discharge) and during follow-up at 4 weeks and 12 weeks.
measure: Traditional Chinese Medicine Syndrome Efficacy Evaluation
timeFrame: These evaluations will be carried out on Day 0, Day 4, Day 7, Day 14 (or at discharge).
measure: Comprehensive Clinical Efficacy Assessment
timeFrame: This evaluation will be conducted on Day 14 (or at discharge).
measure: Modified Pneumonia Imaging Absorption Evaluation Scale
timeFrame: The evaluations will be conducted on Day 0, Day 7 (or at discharge), and at 12 weeks during follow-up.
measure: Pathogen Clearance Rate
timeFrame: This will be assessed at pre-treatment, Day 7, Day 14 (or at discharge) for each patient.
measure: Readmission Rate
timeFrame: The readmission rate will be assessed at 4 weeks and 12 weeks during follow-up, with a detailed record of the reasons for readmission.
Other outcomes:
Locations:
Study officials:
affiliation: The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
name: Jiansheng Li, Doctor
role: STUDY_CHAIR
References: