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Multicenter Phase II Trial of NRICM102 Combined With Standard Therapy in Pneumonia
Sponsor: National Research Institute of Chinese Medicine, Ministry of Health and Welfare
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
Key Details
Gender
All
Age Range
18 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2026-06
Completion Date
2027-11
Last Updated
2026-05-13
Healthy Volunteers
No
Conditions
Interventions
NRICM102
1. 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
Placebo
Intravenous Antibiotic
Intravenous Antibiotic
Locations (1)
National Research Institute of Chinese Medicine, Ministry of Health and Welfare
Taipei, Taiwan