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
National Research Institute of Chinese Medicine, Ministry of Health and Welfare
Lead sponsor
StatPlus,Inc.
Collaborator