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Phase IV Trial,The Efficacy and Safety Study of Fuganlin Oral Liquid in Children With Acute Upper Respiratory Infection
Phase IV trial,Single-arm, multi-centre clinical trial to assess the efficacy and safety of Fuganlin Oral Liquid in children with acute upper respiratory infection
Details
| Lead sponsor | Guangzhou Yipinhong Pharmaceutical CO.,LTD |
|---|---|
| Status | COMPLETED |
| Enrolment | 2400 |
| Start date | 2013-08 |
| Completion | 2017-05 |
Conditions
- Acute Upper Respiratory Infection
Interventions
- Low-dose of Fuganlin Oral Liquid
- High-dose of Fuganlin Oral Liquid
Primary outcomes
- Duration of cold symptoms — Defined as the time from the onset of the cold to the time achieve a cold cure standard,time average 1 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 numbers of normal or low 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