Clinical Trial of Fei Re Qing Granules in the Treatment of Elderly Community-Acquired Pneumonia
NCT ID: NCT06747325
Last Updated: 2024-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
120 participants
INTERVENTIONAL
2025-01-01
2025-06-01
Brief Summary
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Detailed Description
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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
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Test group
The patients in the trial group received routine standard treatments, and oral Fei Re Qing Granules (One bag/time, 3 times/day).
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.)
Routine standard treatments
Routine standard treatments
Control group
The patients in the control group received routine standard treatments, and Placebo granules
Routine standard treatments
Routine standard treatments
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
Interventions
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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.)
Routine standard treatments
Routine standard treatments
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
Eligibility Criteria
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Inclusion 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 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.
65 Years
80 Years
ALL
No
Sponsors
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Third Affiliated Hospital of Henan University of Traditional Chinese Medicine
OTHER
The First Affiliated Hospital of Henan university of CM
UNKNOWN
Henan University of Traditional Chinese Medicine
OTHER
Responsible Party
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Principal Investigators
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Jiansheng Li, Doctor
Role: STUDY_CHAIR
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
Central Contacts
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Other Identifiers
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TCM for Elderly CAP
Identifier Type: -
Identifier Source: org_study_id