Evaluate the Efficacy and Safety of "Formosa 1-Breath Free (NRICM101) " in Subjects With the Symptoms of COVID-19 or Influenza-like Disease
NCT ID: NCT06175468
Last Updated: 2023-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
170 participants
INTERVENTIONAL
2023-12-15
2024-08-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo control group
take the placebo drug 5g/bag、three times a day, treatment for 5 days
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.
Treatment group
take the Formosa 1-Breath Free (NRICM101) 5g/bag、three times a day, treatment for 5 days
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.
Interventions
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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.
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
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Inclusion Criteria
* 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 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.
20 Years
ALL
No
Sponsors
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Tian-I Pharmaceutical,. Co. Ltd.
UNKNOWN
China Medical University, China
OTHER
Qualitix Clinical Research Co., Ltd.
INDUSTRY
China Medical University Hospital
OTHER
Responsible Party
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Principal Investigators
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Chia-Ing Li, PhD
Role: STUDY_CHAIR
Associate Professor
Locations
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China Medical University Hospital
Taichung, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Chia-Ing Li, PhD
Role: primary
Other Identifiers
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CMUH112-REC2-154
Identifier Type: -
Identifier Source: org_study_id