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Multicenter Phase II Trial of NRICM102 Combined With Standard Therapy in Pneumonia

NCT07583992 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-05-13

No results posted yet for this study

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

Conditions

  • Mild to Moderate
  • Community-Acquired Pneumonia (CAP)
  • Antibiotic Therapy
  • Intravenous
  • Hospitalisation

Interventions

DRUG

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

DRUG

Placebo

Placebo

DRUG

Intravenous Antibiotic

Intravenous Antibiotic

Sponsors & Collaborators

  • StatPlus,Inc.

    collaborator UNKNOWN

  • National Research Institute of Chinese Medicine, Ministry of Health and Welfare

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2027-03-31
Completion
2027-11-30

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07583992 on ClinicalTrials.gov