Clinical trial NCT06175468: Evaluate the Efficacy and Safety of "Formosa 1-Breath Free (NRICM101) " in Subjects With the Symptoms of COVID-19 or Influenza-like Disease
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Influenza Viral Infections
COVID-19
Keywords: Formosa 1-Breath Free (NRICM101)
COVID-19
Influenza
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
Collaborators: name: Tian-I Pharmaceutical,. Co. Ltd.
name: China Medical University, China
name: Qualitix Clinical Research Co., Ltd.
First posted: 2023-12-19
Enrollment: 170
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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) " . 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Sore Throat Visual Analogue Scale (VAS)
timeFrame: 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:
measure: Cough Cough Symptom Score (CSS)
timeFrame: 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
measure: Fatigue Visual Analogue Scale (VAS)
timeFrame: 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
measure: Nasal Symptoms Total Nasal Symptom Score (TNSS)
timeFrame: 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
measure: Fever Level
timeFrame: Fever measurements will be taken before the first dose, and one hour after each dose for 5 days
measure: Safety evaluation
timeFrame: Record the adverse event form the baseline to the end of study and follow up to 14 days
measure: Traditional Chinese Medicine (TCM) Syndrome Severity
timeFrame: 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.
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital
Study officials:
affiliation: Associate Professor
name: Chia-Ing Li, PhD
role: STUDY_CHAIR
References: