Evaluate the Efficacy of RespireAidTM in Patient With Externally Contracted Seasonal Epidemic (外感時疫)

NCT06086093 | Completed

• 1 other identifier: MOHW-112-CM3B-01
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 2

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, 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.

Conditions

Respiration Disorders

Keywords

RespireAid; Externally Contracted Seasonal Epidemic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• the "time to symptom-free for sore throat" will be analyzed as the analysis of the primary efficacy endpoint.

  1 week

Study Arms (2)

placebo

PLACEBO COMPARATOR

Take 1 sachet(5g) 4 times daily.

Dietary Supplement: RespireAid TM/placebo

RespireAid

EXPERIMENTAL

Take 1 sachet(5g) 4 times daily.

Dietary Supplement: RespireAid TM/placebo

Interventions

RespireAid TM/placebo DIETARY_SUPPLEMENT

Direction: Take 1 sachet(5g) 4 times daily Indication: Externally contracted seasonal epidemic Function: Relieving Exterior and Facilitating Lung, clear heat of lung, Wide chest and resolve phlegm

RespireAid; placebo

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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. -

Sponsors & Collaborators

• Sun Ten Pharmaceutical Co., Ltd.: lead

Study Sites (2)

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 807, Taiwan

Location

Linkou Chang-Gung Memorial Hospital

Taoyuan District, Taiwan

Location

MeSH Terms

Conditions

Respiration Disorders

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2023
• First Posted: October 17, 2023
• Study Start: August 7, 2023
• Primary Completion: October 11, 2023
• Study Completion: December 15, 2023
• Last Updated: December 22, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

TW (2)