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

May 7, 2026 updated by: National Research Institute of Chinese Medicine, Ministry of Health and Welfare

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 11221
        • National Research Institute of Chinese Medicine, Ministry of Health and Welfare
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Male or female subjects aged 18 to 85 years

  2. The subjects are diagnosed with community-acquired pneumonia (CAP) at the time of hospital admission and must meet all of the following criteria:

    Chest X-ray showing new onset or persistent pulmonary infiltrate At least two of the following abnormal clinical or laboratory findings: (a) Cough, (b) Sputum production, (c) Fever (≥37.8℃) or hypothermia (<35℃), (d) Auscultatory findings of rales or bronchial breath sounds, (e) White blood cell count greater than 10×10⁹/L or less than 4×10⁹/L

  3. Subjects requiring hospitalization and intravenous antibiotic therapy
  4. Subjects who have received standard antibiotic therapy for less than 24 hours after hospital admission
  5. Subjects who are able to take the investigational product orally
  6. Subjects who are able to understand and comply with all study procedures and provide written informed consent

Exclusion Criteria:

  1. 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
  2. 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
  3. Subjects who have been hospitalized within 15 days prior to current admission
  4. Subjects with aspiration pneumonia
  5. Subjects requiring admission to the intensive care unit (ICU)
  6. Subjects requiring hemodialysis
  7. 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)
  8. Subjects with human immunodeficiency virus (HIV) infection
  9. Subjects requiring long-term use of non-steroidal anti-inflammatory drugs (NSAIDs), steroids, or other immunosuppressants
  10. Subjects requiring antiviral agents for COVID-19 infection or influenza
  11. Subjects must be on a stable dose of Omeprazole or Warfarin
  12. Subjects with alcohol or substance abuse, or other major organic diseases, such as chronic obstructive pulmonary disease (COPD), asthma, cystic fibrosis, tuberculosis (TB), or significant heart, kidney, or other major organ dysfunction or failure (based on medical history)

  13. Female subjects who are pregnant, breastfeeding, or of childbearing potential, or those intending to become pregnant between the signing of the Informed Consent Form (ICF) and the final observation/study time point, or who are unwilling to use an appropriate method of contraception. Acceptable highly effective methods of contraception include:

    1. Surgical sterilization (male or female), contraceptive implants, or intrauterine devices (IUDs).
    2. Injectable contraceptives, oral contraceptives, contraceptive patches, or vaginal rings, used in combination with one barrier method.*
    3. Combination of two barrier methods.* *Effective barrier methods include diaphragms, male or female condoms, contraceptive sponges, or spermicides (creams or gels containing spermicidal chemicals).
  14. Subjects deemed unsuitable for study participation by the investigator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Placebo
Drug: Intravenous Antibiotic
Intravenous Antibiotic
Experimental: NRICM102
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: Intravenous Antibiotic
Intravenous Antibiotic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time from initiation of treatment to clinical stability
Time Frame: 30 Days
"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
30 Days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical success rate on Day 4 and Day 8 (Clinical Success)
Time Frame: 8 Days
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
8 Days
Subjective assessment of clinical success
Time Frame: 8 Days
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
8 Days
Improvement rate based on chest X-ray findings
Time Frame: 8 Days
8 Days
Rate of hospital readmission within 30 days from the initiation of treatment
Time Frame: 30 Days
30 Days
Mortality within 30 days from the initiation of treatment
Time Frame: 30 Days
30 Days
ICU admission rate within 30 days from the initiation of treatment
Time Frame: 30 Days
30 Days
Time to IV switch from intravenous (IV) to oral antibiotics
Time Frame: 30 Days
30 Days
Length of hospitalization
Time Frame: 30 Days
30 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

StatPlus,Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

November 1, 2027

Study Registration Dates

First Submitted

May 7, 2026

First Submitted That Met QC Criteria

May 7, 2026

First Posted (Actual)

May 13, 2026

Study Record Updates

Last Update Posted (Actual)

May 13, 2026

Last Update Submitted That Met QC Criteria

May 7, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NRICM102-201

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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