Evaluate the Efficacy and Safety of "Formosa 1-Breath Free (NRICM101) " in Subjects With the Symptoms of COVID-19 or Influenza-like Disease

December 17, 2023 updated by: China Medical University Hospital

A Randomized, Double-blind, Parallel, Placebo-control Study to Evaluate the Efficacy and Safety of "Formosa 1-Breath Free (NRICM101) " in Subjects With the Symptoms of COVID-19 or Influenza-like

"Formosa 1-Breath Free (NRICM101) " has been widely known in Taiwan to treat COVID-19. However, there is no phase III pivotal clinical trial of "Formosa 1-Breath Free (NRICM101) " . In order to obtain scientific, standardized, and comparable clinical results, the study will be implemented to evaluate the efficacy of safety of "Formosa 1-Breath Free (NRICM101) ".

The objective of the study was used the product which be provided by Tian-I Pharmaceutical Co. Ltd. to evaluate the efficacy and safety of the subjects with the symptoms of COVID-19 or Influenza-like after taking "Formosa 1-Breath Free (NRICM101) ".

This study is a randomized, double-blind, parallel controlled clinical trial. The study consisted of 3 cycles: screening period, treatment period (5 days) and follow-up period. The treatment of this study is divided into two groups: The test drug is Formosa 1-Breath Free (NRICM101) granule 5g/bag, 3 times a day；The control drug is the placebo (dummy) 5g/bag, 3 times a day. The sample size in the study is at least 150 people who can be evaluated, and the dropout rate of the test is 10-15%. The estimated sample size is around 170 people. After signing the ICF, vital signs (sitting blood pressure, pulse rate, SpO2, respiratory rate and body temperature), physical examination, chest X-ray, and laboratory test will be checked in screening period. Only subjects with clinically acceptable and following the inclusion and exclusion criteria will eligible to enroll in this study. Compliance will be assured by administration of the study drug under the supervision of the investigator or his deputy. Subjects will be free to withdraw at any time without stating any reason. Data will be analyzed from those subjects who complete the entire study; however, the case report forms and the final study report should include reasons for withdrawals and any necessary treatment.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

170

Phase

  • Phase 3

Contacts and Locations

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

Study Contact

Study Locations

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:

  • Subjects who meet the criteria guideline in the "Seasonal Influenza Prevention and Control Manual" recommended by the Taiwan Centers for Disease Control, or are determined by the investigator to have mild symptoms of COVID-19, including fever, sore throat, cough, and fatigue.
  • Subjects who have had a fever (body temperature ≥37.5°C and ≤39°C) before their initial dose.
  • Throat pain intensity score >30 points during the screening period.
  • Cough severity score >3 points during the screening period.
  • Fatigue level score >30 points during the screening period.
  • Able to perform activities of daily living and aged 20 weeks or older.
  • Duration of illness ≤24 hours.
  • Obtained informed consent from the subject and signed the informed consent form.

Exclusion Criteria:

  • Subject has used other medications for this condition (including cold medicine, antibiotics, antiviral drugs, and similar traditional Chinese medicines) within the 24 hours prior to screening, or is determined by the investigator to require the use of antibiotics or COVID-19 anti-virus drugs.
  • Subject has used corticosteroids or NSAIDs for an extended period within the four weeks prior to screening.
  • Subject has had poorly controlled chronic diseases in the past five years, including cardiovascular, respiratory, gastrointestinal, immune-related conditions, or mental health disorders (as determined by the investigator).
  • Subject has had chronic bronchitis, streptococcal pharyngitis, herpetic pharyngitis, or pneumonia within the past two years or at the time of screening (as determined by the investigator).
  • Subject is allergic to the investigational drug or its components.
  • Women who are pregnant, breastfeeding, or planning to become pregnant.
  • Subject has participated in other drug clinical trials within the 90 days prior to screening.
  • The investigator evaluates the subject unsuitable for inclusion in the study.

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo control group
take the placebo drug 5g/bag、three times a day, treatment for 5 days
Drug: Placebo control drug
After screening, the treatment of this study is divided into two groups: The placebo control group is the placebo (dummy) 5g/bag, 3 times a day.
Active Comparator: Treatment group
take the Formosa 1-Breath Free (NRICM101) 5g/bag、three times a day, treatment for 5 days
Drug: Formosa 1-Breath Free (NRICM101)
After screening, the treatment of this study is divided into two groups: The treatment group is Formosa 1-Breath Free (NRICM101) granule 5g/bag, 3 times a day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sore Throat Visual Analogue Scale (VAS)
Time Frame: Sore throat will be recorded prior to the first dose, one hour after the first dose every morning, and one hour after the last dose for 5 days
Assessing the improvement in sore throat in subjects with symptoms of COVID-19 or influenza-like symptoms. Using the Visual Analogue Scale (VAS) with a range of 0-100, the absolute value of the baseline change in pain intensity is calculated as the Sum of Pain Intensity Differences (SPID), serving as an indicator of the degree of therapeutic improvement.
Sore throat will be recorded prior to the first dose, one hour after the first dose every morning, and one hour after the last dose for 5 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cough Cough Symptom Score (CSS)
Time Frame: Cough will be recorded prior to the first dose, one hour after the first dose every morning, and one hour after the last dose for 5 days
Evaluate the improvement in the severity of cough in subjects with symptoms of COVID-19 or influenza-like symptoms. Use the Cough Symptom Score (CSS) to calculate the baseline change as an indicator of the degree of therapeutic improvement.
Cough will be recorded prior to the first dose, one hour after the first dose every morning, and one hour after the last dose for 5 days
Fatigue Visual Analogue Scale (VAS)
Time Frame: Fatigue will be recorded prior to the first dose, one hour after the first dose every morning, and one hour after the last dose for 5 days
Assess the improvement in fatigue in subjects with symptoms of COVID-19 or influenza-like symptoms. Use the Visual Analogue Scale (VAS) with a range of 0-100 as an indicator to calculate the absolute value of baseline change as a measure of therapeutic improvement.
Fatigue will be recorded prior to the first dose, one hour after the first dose every morning, and one hour after the last dose for 5 days
Nasal Symptoms Total Nasal Symptom Score (TNSS)
Time Frame: Nasal symptoms will be recorded prior to the first dose, one hour after the first dose every morning, and one hour after the last dose for 5 days
Assess the improvement in nasal symptoms in subjects with symptoms of COVID-19 or influenza-like symptoms. Use total nasal symptom score (TNSS) with a range of 0-100 as an indicator to calculate the absolute value of baseline change as a measure of therapeutic improvement.
Nasal symptoms will be recorded prior to the first dose, one hour after the first dose every morning, and one hour after the last dose for 5 days
Fever Level
Time Frame: Fever measurements will be taken before the first dose, and one hour after each dose for 5 days
Evaluate the improvement in fever in subjects with symptoms of COVID-19 or influenza-like symptoms. Calculate the time (in hours) from the first dose of medication to the first onset of temperature relief, as well as the time from complete relief to a normal value. Temperature relief is defined as a temperature below 37.5°C, and the time for final complete relief is the point in time after the last occurrence of fever when the temperature returns to normal. Additionally, calculate the baseline change in temperature for each measurement as an indicator of therapeutic improvement.
Fever measurements will be taken before the first dose, and one hour after each dose for 5 days
Safety evaluation
Time Frame: Record the adverse event form the baseline to the end of study and follow up to 14 days
Evaluate the safety of subjects with symptoms of COVID-19 or influenza-like symptoms after administration of the medication to the end of study
Record the adverse event form the baseline to the end of study and follow up to 14 days
Traditional Chinese Medicine (TCM) Syndrome Severity
Time Frame: The Traditional Chinese Medicine (TCM) syndrome will be assessed by the physician during the screening period and at the final follow-up visit up to 14 days.
Evaluate the improvement in Traditional Chinese Medicine (TCM) syndrome severity in subjects with symptoms of COVID-19 or influenza-like symptoms. Assess the TCM syndrome efficacy using two TCM syndrome scoring scales for primary and secondary symptoms, respectively. Calculate the total scores for the primary symptom scale, the total scores for the secondary symptom scale, and the total syndrome scores (including both primary and secondary symptoms) as indicators of baseline change in absolute values.
The Traditional Chinese Medicine (TCM) syndrome will be assessed by the physician during the screening period and at the final follow-up visit up to 14 days.

Collaborators and Investigators

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

Sponsor

China Medical University Hospital

Collaborators

China Medical University, China
Qualitix Clinical Research Co., Ltd.
Tian-I Pharmaceutical,. Co. Ltd.

Investigators

  • Study Chair: Chia-Ing Li, PhD, Associate professor

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)

December 15, 2023

Primary Completion (Estimated)

April 1, 2024

Study Completion (Estimated)

August 1, 2024

Study Registration Dates

First Submitted

December 13, 2023

First Submitted That Met QC Criteria

December 17, 2023

First Posted (Estimated)

December 19, 2023

Study Record Updates

Last Update Posted (Estimated)

December 19, 2023

Last Update Submitted That Met QC Criteria

December 17, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMUH112-REC2-154

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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