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This study is an exploratory clinical trial. It is intended to investigate the efficacy of mesenchymal stem cell-derived exosome nebulization in the treatment of postinfectious cough through a randomized controlled clinical study, with a view to providing better treatment options for patients with postinfectious cough, improving their quality of life, and providing reference data for the subsequent multi-center clinical trials.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mesenchymal stem cell-derived exosomes and conventional treatment group | Experimental | Mesenchymal stem cell derived exosome nebulization (FITCELL 5ml nebulization QD) was combined with compound methoxyphenamine capsule ( "Asmei" 2 capsules oral TID) for cough treatment. |
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| Placebo and conventional treatment group | Placebo Comparator | Normal saline nebulization (0.9% sodium chloride 5ml nebulization QD) was combined with the compound methoxyphenamine capsule ("Asmei" 2 capsules oral TID) for cough treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mesenchymal stem cell derived exosome nebulization combined with compound methoxyphenamine capsule | Drug | Mesenchymal stem cell derived exosome nebulization (FITCELL 5ml nebulization QD) was combined with compound methoxyphenamine capsule ( "Asmei" 2 capsules oral TID) for cough treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| The change value of Leicester cough questionnaire | The primary endpoint of the study is the statistical difference in the absolute value of changes in the Leicester Cough Questionnaire (LCQ) score from baseline to Day 7 of treatment between the two groups of patients. | Day 7 of treatment initiation |
| Measure | Description | Time Frame |
|---|---|---|
| The change value of Leicester cough questionnaire | The secondary endpoint of the study is the statistical difference in the absolute value of changes in the Leicester Cough Questionnaire (LCQ) score from baseline to Day 14 of treatment between the two groups of patients. | Day 14 of treatment initiation |
| The change value of cough symptom score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hao Tang | Contact | +8615231788498 | tanghao_0921@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai changzheng hospital | Recruiting | Shanghai | Shanghai Municipality | 200000 | China |
All shared IPD will be de-identified to protect participant privacy, with direct identifiers (e.g., name, contact information, medical record numbers) removed or anonymized. Access to the data will be restricted to authorized researchers with a valid research proposal, ensuring the data is used only for purposes consistent with the original study's goals (e.g., secondary analyses of treatment efficacy or safety).
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|
| Normal saline nebulization combined with the compound methoxyphenamine capsule | Drug | Normal saline nebulization (0.9% sodium chloride 5ml nebulization QD) was combined with the compound methoxyphenamine capsule ("Asmei" 2 capsules oral TID) for cough treatment. |
|
The secondary endpoints of the study include the statistical differences in the absolute values of changes in the Cough Severity Score (CSS) from baseline to Day 7 and Day 14 of treatment between the two groups of patients. |
| Day 7 and day 14 of treatment initiation |
| The change value of visual analog scale | The secondary endpoints of the study include the statistical differences in the absolute values of changes in the Visual Analog Scale (VAS) score from baseline to Day 7 and Day 14 of treatment between the two groups of patients. | Day 7 and day 14 of treatment initiation |
| The change value of Athens Insomnia Scale | The secondary endpoints of the study include the statistical differences in the absolute values of changes in the Airway Inflammation Score (AIS) from baseline to Day 7 and Day 14 of treatment between the two groups of patients. | Day 7 and day 14 of treatment initiation |