An interventional study of RespireAid TM/placebo in Respiration Disorders, sponsored by Sun Ten Pharmaceutical Co., Ltd.. Completed at 2 sites in Taiwan. Open to participants aged 18 Years to 79 Years. Per ClinicalTrials.gov, last updated 2023-12-22.
Sponsored by Sun Ten Pharmaceutical Co., Ltd. · Not applicable, Interventional, and Treatment
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.
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.
359 studies on the registry are indexed under Respiration Disorders; 64 are open to participants now.
This study's enrollment of 260 is above the median of 69 across 216 interventional studies indexed under Respiration Disorders.
Browse Respiration Disorders studies →This is the only study on the registry with Sun Ten Pharmaceutical Co., Ltd. as lead sponsor.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Take 1 sachet(5g) 4 times daily.
Dietary Supplement: RespireAid TM/placebo
Take 1 sachet(5g) 4 times daily.
Dietary Supplement: RespireAid TM/placebo
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
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
the "time to symptom-free for sore throat" will be analyzed as the analysis of the primary efficacy endpoint.
Time frame: 1 week
Plan to share: No
Ran from Aug 2023 to primary completion in Oct 2023, 2 months.
Of 111 interventional studies with no phase under Respiration Disorders, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 35. This study's 2 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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