Multicenter Phase II Trial of NRICM102 Combined With Standard Therapy in Pneumonia (NCT07583992) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Multicenter Phase II Trial of NRICM102 Combined With Standard Therapy in Pneumonia
Taiwan150 participantsStarted 2026-06
Plain-language summary
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
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male or female subjects aged 18 to 85 years
. The subjects are diagnosed with community-acquired pneumonia (CAP) at the time of hospital admission and must meet all of the following criteria:
. 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 are able to understand and comply with all study procedures and provide written informed consent
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Time from initiation of treatment to clinical stability
Timeframe: 30 Days
Trial details
NCT IDNCT07583992
SponsorNational Research Institute of Chinese Medicine, Ministry of Health and Welfare
. 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
. Subjects requiring admission to the intensive care unit (ICU)
. Subjects requiring hemodialysis
. Subjects with any malignancy, except those who have completed curative treatment with no signs of recurrence for more than five years and require no further anticancer therapy (based on medical history)
. Subjects with human immunodeficiency virus (HIV) infection