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The purpose of this study is evaluate the efficay and safety of benzonatate soft capsules for improving adult cough symtoms.
The purpose of this study is evaluate the efficay and safety of benzonatate soft capsules for improving adult cough symtoms. The study was designed to be randomized, double-blind, placebo-controlled.Subjects were randomly assigned to the benzonatate soft capsule group and the placebo group on a 1:1 basis。According to the regulatory requirements, 200 cases were planned to be included. Considering that poor efficacy of the placebo control group might lead to shedding, a 10% increase in shedding was achieved, and 220 cases were finally determined, with 110 cases in each group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| benzonatate soft capsules group | Active Comparator |
| |
| control group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Benzonatate 200 mg | Drug | 200 mg/pellet, 1pellet/time, 3times/day |
| |
| Measure | Description | Time Frame |
|---|---|---|
| reducion of cough symptoms total scores | The reduction of cough symptoms will be evaluated by comparative score index basal and final score | 7days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lou Kun, Master | Contact | 0311-67808817 | loukun@mail.ecspc.com |
| Name | Affiliation | Role |
|---|---|---|
| Cao Zhaolong, M.D. | Peking University People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing hospital | Recruiting | Beijing | Beijing Municipality | 100000 | China |
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| blank control 0mg |
| Drug |
0 mg/pellet, 1pellet/time, 3times/day |
|
| Beijing luhe hospital affiliated to capital medical university | Recruiting | Beijing | Beijing Municipality | 100000 | China |
|
| Beijing pinggu district hospital | Recruiting | Beijing | Beijing Municipality | 100000 | China |
|
| Peking University People's Hospital | Recruiting | Beijing | Beijing Municipality | 100000 | China |
|
| Second affiliated hospital of Harbin medical university | Recruiting | Harbin | Heilongjiang | 150000 | China |
|
| Zhengzhou first people's hospital | Recruiting | Zhengzhou | Henan | 450000 | China |
|
| Second Hospital of Xiangya | Recruiting | Changsha | Hunan | 410000 | China |
|
| Affiliated hospital of Inner Mongolia medical university | Recruiting | Hohhot | Inner Mongolia | 010000 | China |
|
| Inner Mongolia autonomous region people's hospital | Recruiting | Hohhot | Inner Mongolia | 010000 | China |
|
| First hospital of jilin university | Recruiting | Changchun | Jilin | 130000 | China |
|
| Jilin Province People's Hospital | Recruiting | Changchun | Jilin | 130000 | China |
|
| Affiliated Zhongshan Hospital Dalian University | Recruiting | Dalian | Liaoning | 116000 | China |
|
| First Affiliated Hospital of China Medical University | Recruiting | Shenyang | Liaoning | 110000 | China |
|
| Central hospital of yangpu district, Shanghai | Recruiting | Shanghai | Shanghai Municipality | 200000 | China |
|
| ID | Term |
|---|---|
| D003371 | Cough |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C029755 | benzonatate |
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