Respiration DisordersNCT06086093
Evaluate the Efficacy of RespireAidTM in Patient With Externally Contracted Seasonal Epidemic (外感時疫)
A study of Respiration Disorders, run by Sun Ten Pharmaceutical Co., Ltd. at 2 sites in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Respiration Disorders
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 260 participants
- Where
- 2 sitesTaiwan
- Study dates
- 7 Aug 2023to 15 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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. -
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807
Linkou Chang-Gung Memorial Hospital
Taoyuan
About this study
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.
Read the 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 this study (dropout rate 10%). There will be 2 visits in this study. In Visit 1 (Day 1), subjects who have the symptoms of fever, sore throat, and cough (match the definition in table 1 to 3 in protocol), by investigator's judgement will be recruited into the study. Subjects will be randomized into the RespireAidTM group or placebo group with allocation rate 2:1. Following to the clinical guideline of NRICM101, subjects in RespireAidTM group will take drug four times daily with 20g oral granule, administered for 5 days. The subjects in placebo group received study drug with the same dose frequency. Other than study drugs, the rescue drug, acetaminophen, will be administered. If subjects have moderate or severe fever, sore throat, he/she could receive one rescue medication (500mg) per 4 hours, up to 6 tablets in total in one day. Subjects will be educated how to use e-dairy. The dairy will be recorded the severity of fever, sore throat, and cough from baseline (Day 1, before use of study drug) to Day 5. The efficacy endpoint will be the improvement of fever, sore throat, and cough, and the safety endpoint will be adverse events after treatment. The study and rescue drugs will be dispensed to subjects and the study staff will teach them how to receive medications. If subjects have persistent fever, unscheduled visits will be arranged to check whether or not they would be suitable to participate into this study.
Adverse events will be recorded at Visit 2(Day 8), and the dairy with drug record will be checked.
- Conditions
- Respiration Disorders
- Being tested
- RespireAid TM/placebo
- Keywords
- RespireAid, Externally Contracted Seasonal Epidemic
- Medical subject headings
- Respiration Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RespireAid TM/placeboDietary 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
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | Take 1 sachet(5g) 4 times daily. Receives: Dietary Supplement: RespireAid TM/placebo |
| RespireAid | Experimental | Take 1 sachet(5g) 4 times daily. Receives: Dietary Supplement: RespireAid TM/placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 days
Secondary outcomes (1)
the "time to symptom-free for sore throat" will be analyzed as the analysis of the primary efficacy endpoint.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2023
- Study start7 Aug 2023
- Primary completion11 Oct 2023
- Study completion15 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiration DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Ten Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06086093
- Sponsor's protocol ID
- MOHW-112-CM3B-01
- Status last verified
- Dec 2023
- First submitted
- 3 Oct 2023
- Last updated
- 22 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate the Efficacy of RespireAidTM in Patient With Externally Contracted Seasonal Epidemic (外感時疫)
- ClinicalTrials.gov ID
- NCT06086093
- Acronym / sponsor ID
- MOHW-112-CM3B-01
- Conditions
- Respiration Disorders
- Keywords
- RespireAid, Externally Contracted Seasonal Epidemic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Sun Ten Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 7 Aug 2023 (actual)
- Primary completion
- 11 Oct 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 17 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 this study (dropout rate 10%). There will be 2 visits in this study. In Visit 1 (Day 1), subjects who have the symptoms of fever, sore throat, and cough (match the definition in table 1 to 3 in protocol), by investigator's judgement will be recruited into the study. Subjects will be randomized into the RespireAidTM group or placebo group with allocation rate 2:1. Following to the clinical guideline of NRICM101, subjects in RespireAidTM group will take drug four times daily with 20g oral granule, administered for 5 days. The subjects in placebo group received study drug with the same dose frequency. Other than study drugs, the rescue drug, acetaminophen, will be administered. If subjects have moderate or severe fever, sore throat, he/she could receive one rescue medication (500mg) per 4 hours, up to 6 tablets in total in one day. Subjects will be educated how to use e-dairy. The dairy will be recorded the severity of fever, sore throat, and cough from baseline (Day 1, before use of study drug) to Day 5. The efficacy endpoint will be the improvement of fever, sore throat, and cough, and the safety endpoint will be adverse events after treatment. The study and rescue drugs will be dispensed to subjects and the study staff will teach them how to receive medications. If subjects have persistent fever, unscheduled visits will be arranged to check whether or not they would be suitable to participate into this study.
Adverse events will be recorded at Visit 2(Day 8), and the dairy with drug record will be checked.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Dietary Supplement: RespireAid TM/placeboTake 1 sachet(5g) 4 times daily. |
| RespireAid | Experimental | Dietary Supplement: RespireAid TM/placeboTake 1 sachet(5g) 4 times daily. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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. -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RespireAid TM/placeboDirection: 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 | Dietary supplement | RespireAid, placebo |
Primary outcome
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.
Time frame: 5 days
1 secondary outcome
the "time to symptom-free for sore throat" will be analyzed as the analysis of the primary efficacy endpoint.
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2023.
- Individual participant dataSharing planned: No
Related trials for Respiration Disorders
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Not yet recruiting
Miniature In-line Respirator
Brain Death, Respiration, Artificial
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
Not yet recruiting
Effect of Box Breathing Exercise on Anxiety, Pain, and Pulmonary Function Tests in Patients Undergoing Colonoscopy
Colonoscopy
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Respiration Disorders, run by Sun Ten Pharmaceutical Co., Ltd. at 2 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2023.