Status:
COMPLETED
Evaluate the Efficacy of RespireAidTM in Patient With Externally Contracted Seasonal Epidemic (外感時疫)
Lead Sponsor:
Sun Ten Pharmaceutical Co., Ltd.
Conditions:
Respiration Disorders
Eligibility:
All Genders
18-79 years
Phase:
NA
Brief Summary
The goal of this clinical trial is to learn about in the main objective of this study is to evaluate the clinical efficacy of the RespireAidTM (Tai-wan-Qing-Guan-Yi-Hao) to ease the symptoms of fever,...
Detailed Description
This is a multicenter, parallel, double-blind, randomized, placebo-controlled study. A total of 258 male or unpregnant female outpatient subjects ≥ 18 years to ≤ 79 years of age will be enrolled into ...
Eligibility Criteria
Inclusion
- Male or unpregnant female patients ≥ 18 years to ≤ 79 years of age, who have the symptoms of fever, sore throat, and cough (match the definition in table 1 to 2 in protocol), by investigator's judgement, with mild to severe symptoms (\> 20 mm in each VAS).
- With BMI between 18 to 30 kg/m².
- Without a history for alcohol or drug abuse, or other significant organic diseases.
- No history of cancer. Unless no signs of relapse occurred for over 5 years which no anticancer therapies are needed.
- Ability to read and write Chinese, and provide data through questionnaire.
- Ability to understand and comply all procedures of the study, and provide written consent.
Exclusion
- Confirmed diagnosis of pneumonia or other disease by chest X ray which would impact on study evaluations.
- Must require long-term use of NASIDs, corticosteroids or other immunosuppressive agents.
- Pregnant female.
- Subjects are not suitable for the conduct of the study for any other reasons, determined by the investigator. For example, subjects who require to use antibiotics, COVID-19 or influenza antiviral drugs. -
Key Trial Info
Start Date :
August 7 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2023
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT06086093
Start Date
August 7 2023
End Date
December 15 2023
Last Update
December 22 2023
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan, 807
2
Linkou Chang-Gung Memorial Hospital
Taoyuan District, Taiwan