Trials Sponsors Conditions Drugs Pricing

Conditions

COVID-19 Influenza Viral Infections

Keywords

Formosa 1-Breath Free (NRICM101)COVID-19Influenza

Outcome Measures

Primary Outcomes (1)

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.
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)
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)
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)
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
Fever measurements will be taken before the first dose, and one hour after each dose for 5 days
Safety evaluation
Record the adverse event form the baseline to the end of study and follow up to 14 days
+1 more secondary outcomes

Study Arms (2)

Placebo control group

PLACEBO COMPARATOR

take the placebo drug 5g/bag、three times a day, treatment for 5 days

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

Drug: Formosa 1-Breath Free (NRICM101)

Interventions

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.

Treatment group

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.

Placebo control group

Eligibility Criteria

Age20 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

Sponsors & Collaborators

Tian-I Pharmaceutical,. Co. Ltd.
Type not reportedcollaborator
Qualitix Clinical Research Co., Ltd.
Industrycollaborator
China Medical University, China

Study Sites (1)

China Medical University Hospital

Taichung, Taiwan

Chia-Ing Li, PhDCONTACT886-4-22052121 ext. 14701 006446@tool.caaumed.org.tw

MeSH Terms

Conditions

COVID-19Influenza, Human

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesOrthomyxoviridae Infections

Study Officials

Chia-Ing Li, PhD
Associate Professor
STUDY CHAIR

Central Study Contacts

Chia-Ing Li, PhD

CONTACT

+ 886-4-22052121 006446@tool.caaumed.org.tw

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, INVESTIGATOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

December 13, 2023

First Posted

December 19, 2023

Study Start

December 15, 2023

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Primary Completion

April 2024

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (2)

Placebo control group

Treatment group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (2)

Placebo control group

Treatment group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations