Clinical Trial of Fei Re Qing Granules in the Treatment of Elderly Community-Acquired Pneumonia

Официальное название

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Fei Re Qing Granules in the Treatment of Elderly Community-Acquired Pneumonia

Обзор

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.

Подробное описание

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

Вмешательства

• Препарат 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.)
• Другое Routine standard treatments
  Routine standard treatments
• Препарат 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

Первичные конечные точки

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

Вторичные конечные точки (8)

• Improvement of Clinical Symptoms [Срок оценки: 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 [Срок оценки: 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). [Срок оценки: 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 [Срок оценки: These evaluations will be carried out on Day 0, Day 4, Day 7, Day 14 (or at discharge).]
• Comprehensive Clinical Efficacy Assessment [Срок оценки: This evaluation will be conducted on Day 14 (or at discharge).]
• Modified Pneumonia Imaging Absorption Evaluation Scale [Срок оценки: The evaluations will be conducted on Day 0, Day 7 (or at discharge), and at 12 weeks during follow-up.]
• Pathogen Clearance Rate [Срок оценки: This will be assessed at pre-treatment, Day 7, Day 14 (or at discharge) for each patient.]
• Readmission Rate [Срок оценки: The readmission rate will be assessed at 4 weeks and 12 weeks during follow-up, with a detailed record of the reasons for readmission.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06747325 · TCM for Elderly CAP

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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