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Randomized, double blind, double dummy, positive drug parallel comparison, multi-centre clinical trial to assess the efficacy and safety of Fuganlin Oral Liquid in children with influenza (acute upper respiratory infection).
Treatment group: Fuganlin Oral Liquid 10mL. Control group: Xiaoer Jiebiao oral liquid 100mL. Treatment for one week. Patients who were recovered within one week can withdrawal at any time.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fuganlin Oral Liquid | Experimental | Fuganlin Oral Liquid:oral less than 1 years old: 5mL each time and three times a day 1~3 years old: 10mL each time and three times a day 4~6 years old: 10mL each time and four times a day 7~12 years old: 10mL each time and five times a day Xiaoer Jiebiao Oral Liquid placebo:oral 1~2 years old: 5mL each time and twice a day 3~5 years old: 5mL each time and three times a day 6~14 years old: 10mL each time and twice a day |
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| Xiaoer Jiebiao Oral Liquid | Active Comparator | Xiaoer Jiebiao Oral Liquid:oral 1~2 years old: 5mL each time and twice a day 3~5 years old: 5mL each time and three times a day 6~14 years old: 10mL each time and twice a day Fuganlin Oral Liquid placebo:oral less than 1 years old: 5mL each time and three times a day 1~3 years old: 10mL each time and three times a day 4~6 years old: 10mL each time and four times a day 7~12 years old: 10mL each time and five times a day |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fuganlin Oral Liquid | Drug | less than 1 years old: 5mL each time and three times a day 1~3 years old: 10mL each time and three times a day 4~6 years old: 10mL each time and four times a day 7~12 years old: 10mL each time and five times a day |
| Measure | Description | Time Frame |
|---|---|---|
| The duration of cold symptoms | Cold diagnostic criteria：
Cold cure criteria:
| Defined as the time from the onset of the cold to the time achieve a cold cure standard，time average 3 to 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cao xia, MD | Chongqing First People's Hospital | Principal Investigator |
| Yan yunying, MD | Nanning maternal and Child Health Hospital | Principal Investigator |
| Hu suping, MD | Nanchang City Hospital of integrated traditional Chinese and Western Medicine | Principal Investigator |
| Wang leping, MD | Changzhou traditional Chinese medicine hospital | Principal Investigator |
| Liu Dexing, MD | Liuzhou traditional Chinese medicine hospital | Principal Investigator |
| Qi Shihe, MD | Xiangyang Central Hospital | Principal Investigator |
| Ding Lijun, MD | Handan traditional Chinese medicine hospital | Principal Investigator |
| Yang Liping, MD | Changzhi City People's Hospital | Principal Investigator |
| Feng Ziwei, MD | Luohe traditional Chinese medicine hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Luohe traditional Chinese medicine hospital | Luohe | Henan | 462000 | China |
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| Xiaoer Jiebiao Oral Liquid | Drug | 1~2 years old: 5mL each time and twice a day 3~5 years old: 5mL each time and three times a day 6~14 years old: 10mL each time and twice a day |
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