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

NCT06747325 | Not Yet Recruiting DMC

• 1 other identifier: TCM for Elderly CAP
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Community-Acquired Pneumonia (CAP)

Keywords

elderly community-acquired pneumonia (CAP); traditional Chinese medicine; randomized controlled trial; Fei Re Qing Granules

Outcome Measures

Primary Outcomes (1)

• Time to Clinical Stability

  The criteria for clinical stability require meeting all five of the following indicators: Body temperature ≤ 37.8°C for more than 24 hours; Resting heart rate ≤ 100 beats per minute; Resting respiratory rate ≤ 24 breaths per minute; Systolic blood pressure ≥ 90 mmHg; Oxygen saturation (SpO₂) ≥ 90% (or arterial oxygen partial pressure ≥ 60 mmHg on room air). During the treatment period, log cards will be issued to monitor and record vital signs (temperature, respiration, blood pressure, heart rate, and SpO₂) every 12 hours. The time to clinical stability will be calculated based on these records

  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 (8)

• Improvement of Clinical Symptoms

  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

  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).

  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

  These evaluations will be carried out on Day 0, Day 4, Day 7, Day 14 (or at discharge).

• Comprehensive Clinical Efficacy Assessment

  This evaluation will be conducted on Day 14 (or at discharge).

Study Arms (2)

Test group

EXPERIMENTAL

The patients in the trial group received routine standard treatments, and oral Fei Re Qing Granules (One bag/time, 3 times/day).

Drug: Fei Re Qing Granules; Other: Routine standard treatments

Control group

PLACEBO COMPARATOR

The patients in the control group received routine standard treatments, and Placebo granules

Other: Routine standard treatments; Drug: Placebo granules

Interventions

Fei Re Qing Granules DRUG

Fei Re Qing Granules (Ingredients: Scutellaria baicalensis \[Huang Qin\], Trichosanthes kirilowii \[Gua Lou\], Forsythia suspensa \[Lian Qiao\], Fritillaria thunbergii \[Zhe Bei Mu\], etc.)

Test group

Routine standard treatments OTHER

Routine standard treatments

Control group; Test group

Placebo granules DRUG

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

Control group

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Henan University of Traditional Chinese Medicine: lead
• Third Affiliated Hospital of Henan University of Traditional Chinese Medicine: collaborator
• The First Affiliated Hospital of Henan university of CM: collaborator

MeSH Terms

Conditions

Community-Acquired Pneumonia

Condition Hierarchy (Ancestors)

Community-Acquired Infections; Infections; Pneumonia; Respiratory Tract Infections; Respiratory Tract Diseases

Study Officials

• Jiansheng Li, Doctor

  The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

  STUDY CHAIR

Central Study Contacts

Minghang Wang, Doctor

CONTACT

+86 371 66248624; wmh107hn@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2024
• First Posted: December 24, 2024
• Study Start: January 1, 2025
• Primary Completion: May 1, 2025
• Study Completion: June 1, 2025
• Last Updated: December 24, 2024

Record last verified: 2024-12