Study of Jinye Baidu granule in treatment of wind-warmth lung heat disease (heat in lung-wei pattern)： a randomized, double-blind, parallel-controlled trial.
10.19540/j.cnki.cjcmm.2017.0043
- Author:
Jun-Jie JIANG
1
;
Yan-Ming XIE
1
;
Yong-Yan WANG
1
;
Yuan LI
1
;
Yi-Li ZHANG
1
;
Shuai-Ling SUN
1
;
Shuo WANG
2
;
Yong ZHU
3
;
Wen-Sheng QI
2
;
Xun CHEN
4
;
Qin CHEN
4
Author Information
1. Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China.
2. Guanganmen Hospital Affiliated to China Academy of Chinese Medical Sciences, Beijing 100053, China.
3. Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University, Beijing 100010, China.
4. Sinopharm Zhonglian Pharmaceutical Co.,Ltd., Wuhan 430000, China.
- Publication Type:Journal Article
- Keywords:
Jinye Baidu granule;
heat in lung-wei pattern;
randomized controlled trial;
wind-warmth lung heat disease
- From:
China Journal of Chinese Materia Medica
2017;42(8):1467-1473
- CountryChina
- Language:Chinese
-
Abstract:
A randomized, double-blind, active parallel controlled trial will be conducted to include patients with acute upper respiratory infection and wind-warmth lung heat disease (heat in lung-wei pattern). Patients with serious bacterial infection (white blood cell count>1.2×1010, neutrophil>80%) will be excluded.so as to further identify Jinye Baidu Granule indications of Wind-warmth lung heat disease (heat in lung-wei pattern).According to the subjects of symptoms of fever and sore throats,Patients will be divided into three blocks： fever, swelling and sore throat, combined fever and swelling and sore throat. Subjects in three blocks will be divided into treatment group and control group with stratified blocked randomization. The treatment group will be treated with Jinye Baidu Granule, and the control group will be treated with Fufang Shuanghua granule. Primary outcome measure of patients with fever will be body temperature recovery time. Primary outcome measure of patients with swelling and sore throat will be throat symptom score. Primary outcome measures of patients combined with fever and swelling and sore throat will be body temperature recovery time and throat symptom score. Before and after all of the patients in the group were collected blood and urine routine, liver and renal function, electrocardiogram (ECG) data as the safety index while observing it adverse events. A total of 623 patients were included. Compared with control group,sore throat symptoms of patients with sore throat and pharyngeal symptoms total score have significantly different. so Jinny Baidu granule have a significant advantage in the treatment of sore throat. All of the experiments showed that the safety of the drug was good. Nausea, vomiting, stomach pain, diarrhea, digestive tract symptoms may occur only occasionally. We should pay attention to the changes when using in patients with spleen deficiency cold to avoid adverse reaction.
