Influenza Viral InfectionsPhase 3NCT06175468
Evaluate the Efficacy and Safety of "Formosa 1-Breath Free (NRICM101) " in Subjects With the Symptoms of COVID-19 or Influenza-like Disease
A Phase 3 study testing Formosa 1-Breath Free (NRICM101) in people with Influenza Viral Infections and COVID-19, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
"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) " . Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Influenza Viral Infections, COVID-19
- What is being tested?
- Formosa 1-Breath Free (NRICM101)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 170 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Dec 2023to Aug 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
China Medical University Hospital
Taichung
Chia-Ing Li, PhD, 886-4-22052121 ext. 14701, 006446@tool.caaumed.org.tw
About this study
Official title: 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.
- Conditions
- Influenza Viral Infections, COVID-19
- Being tested
- Formosa 1-Breath Free (NRICM101), Placebo control drug
- Keywords
- Formosa 1-Breath Free (NRICM101), COVID-19, Influenza
- Medical subject headings
- COVID-19, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Formosa 1-Breath Free (NRICM101)Drug
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.
Placebo control drugDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Placebo control group | Placebo comparator | take the placebo drug 5g/bag、three times a day, treatment for 5 days Receives: Drug: Placebo control drug |
| Treatment group | Active comparator | take the Formosa 1-Breath Free (NRICM101) 5g/bag、three times a day, treatment for 5 days Receives: Drug: Formosa 1-Breath Free (NRICM101) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sore Throat Visual Analogue Scale (VAS)
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.
Measured: 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 outcomes (6)
Cough Cough Symptom Score (CSS)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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
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.
Measured: Fever measurements will be taken before the first dose, and one hour after each dose for 5 days
Safety evaluation
Evaluate the safety of subjects with symptoms of COVID-19 or influenza-like symptoms after administration of the medication to the end of study
Measured: Record the adverse event form the baseline to the end of study and follow up to 14 days
Traditional Chinese Medicine (TCM) Syndrome Severity
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2023
- Study start15 Dec 2023 (estimated)
- Primary completionApr 2024 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza Viral InfectionsStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tian-I Pharmaceutical,. Co. Ltd., China Medical University, China, Qualitix Clinical Research Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Chia-Ing Li, PhD, Study chair, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06175468
- Sponsor's protocol ID
- CMUH112-REC2-154
- Status last verified
- Dec 2023
- First submitted
- 13 Dec 2023
- Last updated
- 19 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06175468
- Acronym / sponsor ID
- CMUH112-REC2-154
- Conditions
- Influenza Viral Infections, COVID-19
- Keywords
- Formosa 1-Breath Free (NRICM101), COVID-19, Influenza
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Collaborators
- Tian-I Pharmaceutical,. Co. Ltd., China Medical University, China, Qualitix Clinical Research Co., Ltd.
- Study start
- 15 Dec 2023 (estimated)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 19 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
"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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo control group | Placebo comparator | Drug: Placebo control drugtake the placebo drug 5g/bag、three times a day, treatment for 5 days |
| Treatment group | Active comparator | Drug: Formosa 1-Breath Free (NRICM101)take the Formosa 1-Breath Free (NRICM101) 5g/bag、three times a day, treatment for 5 days |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Treatment group |
| Placebo control drugAfter 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. | Drug | Placebo control group |
Primary outcome
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.
6 secondary outcomes
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
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
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
Fever Level
Time frame: 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
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chia-Ing Li, PhD study chair
Associate Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Formosa 1-Breath Free (NRICM101) in people with Influenza Viral Infections and COVID-19, run by China Medical University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chia-Ing Li, PhD (+ 886-4-22052121 ext. 14701, 006446@tool.caaumed.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2023.