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The Efficacy and Safety Study of Fuganlin Oral Liquid in Children With Influenza (Acute Upper Respiratory Infection)
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).
Details
| Lead sponsor | Guangzhou Yipinhong Pharmaceutical CO.,LTD |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 468 |
| Start date | 2012-03 |
| Completion | 2014-03 |
Conditions
- Acute Upper Respiratory Infection
Interventions
- Fuganlin Oral Liquid
- Xiaoer Jiebiao Oral Liquid
Primary outcomes
- The duration of cold symptoms — Defined as the time from the onset of the cold to the time achieve a cold cure standard，time average 3 to 7 days
Cold diagnostic criteria： 1. nasal congestion, runny nose, sneezing, itchy throat, or pain, cough 2. The chills, fever, no sweat or less sweat, headache, limb sour 3. The total number normal or low of white blood cells, neutropenia, relative increase in lymphocytes Cold cure criteria: 1. fever, aversion to wind individual symptoms disappeared 2. nasal congestion, runny nose, sore throat, cough individual symptoms disappeared
Countries
China