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
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 clinicalresults, the study will be implemented to evaluate the efficacy of safety of "Formosa1-Breath Free (NRICM101) ".The objective of the study was used the product which be provided by Tian-IPharmaceutical Co. Ltd. to evaluate the efficacy and safety of the subjects with thesymptoms 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 studyconsisted 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-BreathFree (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 beevaluated, and the dropout rate of the test is 10-15%. The estimated sample size isaround 170 people. After signing the ICF, vital signs (sitting blood pressure, pulserate, SpO2, respiratory rate and body temperature), physical examination, chest X-ray,and laboratory test will be checked in screening period. Only subjects with clinicallyacceptable and following the inclusion and exclusion criteria will eligible to enroll inthis study. Compliance will be assured by administration of the study drug under thesupervision of the investigator or his deputy. Subjects will be free to withdraw at anytime without stating any reason. Data will be analyzed from those subjects who completethe entire study; however, the case report forms and the final study report shouldinclude reasons for withdrawals and any necessary treatment.

Detailed Description

Not Provided

Not yet recruiting
Influenza Viral Infections
COVID-19

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.

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.

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.

Eligibility Gender
All
Eligibility Age
Minimum: 20 Years ~ Maximum: N/A
Countries
Taiwan
Locations

China Medical University Hospital
Taichung, Taiwan

Investigator: Chia-Ing Li, PhD
Contact: 886-4-22052121
006446@tool.caaumed.org.tw

Contacts

Chia-Ing Li, PhD
+ 886-4-22052121 - 14701
006446@tool.caaumed.org.tw

Chia-Ing Li, PhD, Study Chair
Associate Professor

China Medical University Hospital
NCT Number
Keywords
Formosa 1-Breath Free (NRICM101)
Covid-19
Influenza
MeSH Terms
COVID-19
Influenza, Human
Virus Diseases