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

Overview

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

Interventions

• Drug Fei Re Qing Granules
  Fei Re Qing Granules (Ingredients: Scutellaria baicalensis \[Huang Qin\], Trichosanthes kirilowii \[Gua Lou\], Forsythia suspensa \[Lian Qiao\], Fritillaria thunbergii \[Zhe Bei Mu\], etc.)
• Other Routine standard treatments
  Routine standard treatments
• Drug Placebo granules
  The placebo granules are prepared using 5% of the active drug, ensuring consistency in appearance, weight, color, and odor with the Fei Re Qing Granules

Primary outcome measures

• Time to Clinical Stability [Time frame: From the start of treatment, the time is recorded until the patient reaches clinical stability, whichever came first, assessed up to 2 weeks.]

Secondary outcome measures (8)

• Improvement of Clinical Symptoms [Time frame: 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.]
• Length of Hospital Stay [Time frame: From the start of treatment, the time is recorded until the patient discharge, whichever came first, assessed up to 2 weeks.]
• Confusion, Urea, Respiratory rate, Blood pressure, and Age ≥65 Score (CURB-65 score). [Time frame: 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.]
• Traditional Chinese Medicine Syndrome Efficacy Evaluation [Time frame: These evaluations will be carried out on Day 0, Day 4, Day 7, Day 14 (or at discharge).]
• Comprehensive Clinical Efficacy Assessment [Time frame: This evaluation will be conducted on Day 14 (or at discharge).]
• Modified Pneumonia Imaging Absorption Evaluation Scale [Time frame: The evaluations will be conducted on Day 0, Day 7 (or at discharge), and at 12 weeks during follow-up.]
• Pathogen Clearance Rate [Time frame: This will be assessed at pre-treatment, Day 7, Day 14 (or at discharge) for each patient.]
• Readmission Rate [Time frame: The readmission rate will be assessed at 4 weeks and 12 weeks during follow-up, with a detailed record of the reasons for readmission.]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06747325 · TCM for Elderly CAP

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗