Respiration Disorders Clinical Trial
Official title:
Evaluate the Efficacy of RespireAidTM in Patient With Externally Contracted Seasonal Epidemic (外感時疫)
Verified date | December 2023 |
Source | Sun Ten Pharmaceutical Co., Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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, sore throat, and cough, and the safety after treatment. Participants will Take 1 sachet(5g) 4 times daily. There is a comparison group: Researchers will compare placebo to see if RespireAidTM.
Status | Completed |
Enrollment | 260 |
Est. completion date | December 15, 2023 |
Est. primary completion date | October 11, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 79 Years |
Eligibility | Inclusion Criteria: 1. 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). 2. With BMI between 18 to 30 kg/m². 3. Without a history for alcohol or drug abuse, or other significant organic diseases. 4. No history of cancer. Unless no signs of relapse occurred for over 5 years which no anticancer therapies are needed. 5. Ability to read and write Chinese, and provide data through questionnaire. 6. Ability to understand and comply all procedures of the study, and provide written consent. Exclusion Criteria: 1. Confirmed diagnosis of pneumonia or other disease by chest X ray which would impact on study evaluations. 2. Must require long-term use of NASIDs, corticosteroids or other immunosuppressive agents. 3. Pregnant female. 4. 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. - |
Country | Name | City | State |
---|---|---|---|
Taiwan | Kaohsiung Medical University Chung-Ho Memorial Hospital | Kaohsiung | |
Taiwan | Linkou Chang-Gung Memorial Hospital | Taoyuan |
Lead Sponsor | Collaborator |
---|---|
Sun Ten Pharmaceutical Co., Ltd. |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary efficacy endpoint is the "time to symptom-free for fever" which is the days of the symptom-free for fever based on the diary record. | 5 days | ||
Secondary | the "time to symptom-free for sore throat" will be analyzed as the analysis of the primary efficacy endpoint. | 1 week |
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