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Jinye Baidu granule for wind-warmth lung-heat disease (heat in the lung-wei): protocol for a randomized, double-blind, parallel, controlled trial

Author: Jiang JJ, Zhang Y, Xie YM, Li Y, Sun SL, Zhang YL, Wang S, Zhu Y, Qi WS
Page: 621

Brief:
OBJECTIVE: To observe the curative effect of Jinye Baidu granule in the treatment of fever and swollen and sore throat caused by wind-warmth lung-heat disease (heat in the lung-wei) to further identify the indications. METHODS: This randomized, double-blind, parallel, controlled trial will include patients with acute upper respiratory infection and wind-warmth lung-heat disease (heat in the lung-wei). Patients with serious bacterial infection (white blood cell count > 12 109, neutrophils > 80%) will be excluded. Patients will be divided into three categories (blocks) according to their condition: fever only, a swollen and sore throat, and combined fever plus a swollen and sore throat. Patients within each of the three blocks will be further divided into a treatment group and a control group via stratified blocked randomization. The treatment group will be treated with Jinye Baidu granule, and the control group will be treated with Fufang Shuanghua granule. The primary outcome measure will be body temperature recovery time for patients with fever, throat symptom score for patients with a swollen and sore throat, and body temperature recovery time and throat symptom score for patients with combined fever plus a swollen and sore throat. Routine blood testing, urine testing, liver function, kidney function and ECG data of all patients will be collected as safety indices before and after enrollment, and adverse events will be recorded during the whole trial course. CONCLUSION: This study protocol will include stratified block analysis according to patients' symptoms, and identify the accurate clinical indications of Jinye Baidu granule. It will also enable safety evaluation from laboratory indices and adverse events, which will provide reliable evidence for clinical treatment.

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