The goal of this clinical trial is to learn if NRICM102 (a Traditional Chinese Medicine) works to treat community-acquired pneumonia (CAP) in adults when added to standard antibiotic therapy. It will also learn about the safety of NRICM102. The main questions it aims to answer are:
1. Does NRICM102 help participants reach clinical stability faster compared to placebo? 2. What medical problems do participants have when taking NRICM102?
Researchers will compare NRICM102 to a placebo (a look-alike substance that contains no drug) to see if NRICM102 works as an add-on treatment for community-acquired pneumonia.
Participants will:
1. Take NRICM102 or a placebo (2 sachets, 3 times daily) in addition to standard intravenous antibiotic treatment for 7 days 2. Be hospitalized and visited by the study team on Day 1, Day 4, and Day 8 for vital sign monitoring, symptom assessments, laboratory tests, and chest X-ray examinations 3. Be contacted by telephone on Day 30 to check if they were readmitted to the hospital after discharge
Male or female subjects aged 18 to 85 years
Subjects requiring hospitalization and intravenous antibiotic therapy
Subjects who have received standard antibiotic therapy for less than 24 hours after hospital admission
Subjects who are able to take the investigational product orally
Subjects who have received systemic antibiotic treatment within 72 hours prior to screening; routine antibiotics administered after hospital admission are not included in this restriction
Subjects who have used oral traditional Chinese medicine (TCM) or traditional Chinese medicine preparations that may affect efficacy assessment within 7 days prior to hospital admission
Subjects who have been hospitalized within 15 days prior to current admission
Subjects with aspiration pneumonia
Parallel
NRICM102
Drug1. Name: NRICM102 2. Dosage form: Concentrated granules 3. Unit Content: 5 grams/sachet 4. Dosing schedule: Oral administration, 2 sachets per dose, 3 times daily (total daily dose: 30 grams), for a duration of 7 days 5. Mechanism of action: The main ingredients are believed to inhibit the interaction between the SARS-CoV-2 spike protein and the human angiotensin-converting enzyme 2 (ACE2) receptor, thereby reducing viral entry into host cells. Inhibition of the 3CL protease may suppress viral replication. Additionally, the formulation downregulates inflammatory mediators such as IL-6 and TNF-α, and offers lung protection, anti-fibrotic effects, and potential thrombosis modulation. These properties suggest immunomodulatory and pulmonary protective functions, supporting its use as adjunct therapy in pneumonia. 6. Pharmacological Classification: Traditional Chinese Medicine
Placebo
DrugPlacebo
Intravenous Antibiotic
DrugIntravenous Antibiotic
Time from initiation of treatment to clinical stability
"Clinical Stability" is defined as the maintenance of all the following criteria for more than 24 consecutive hours: Body Temperature \< 37.8 °C Heart Rate \< 100 beats per minute Respiratory Rate \< 24 breaths per minute Systolic Blood Pressure \> 90 mmHg Blood Oxygen Saturation \> 90% on room air (FiO₂: 21%) Able to Eat Orally Alert
Clinical success rate on Day 4 and Day 8 (Clinical Success)
Assessed symptoms include: cough, sputum production, difficulty breathing, and chest pain Clinical success is defined as improvement in at least two of the four assessed symptoms, with no worsening in any symptom Symptom severity is categorized into four levels (None, Mild, Moderate, Severe). An improvement is defined as a decrease of at least one severity level compared to baseline
Subjective assessment of clinical success
Subjective symptoms include: cough, sputum production, difficulty breathing, and chest pain Subjects will rate these symptoms using a Visual Analog Scale (VAS) Symptom assessment is based on the change in score from baseline
Improvement rate based on chest X-ray findings
Rate of hospital readmission within 30 days from the initiation of treatment
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National Research Institute of Chinese Medicine, Ministry of Health and Welfare
Lead sponsor
StatPlus,Inc.
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
