Background To prove the effect of Jinyebaidu Granule (JYBDG) in treating the Disease of Wind-heat Attacking the Lung (type of heat pathogen invading the defensive Qi of the lung) and objectively evaluate its safety. Methods The muti-center,double-blinded, double-dummy and randomized controlled method was adopted to observe 200 patients who were divided into the treatment group (n=100, treated with JYBDG 10 g, three times a day) and the control group (n=100, treated with Shuanghuanglian Granule 5 g, three times a day). The therapeutic course for both groups was 5 days. Results According to ITT (intention-to-treat) and PP (per-protocol population), In the treatment group, the markedly effective rate was 72.64% and 75.00% respectively, and effective rate was 94.00% and 96.00% respectively, while in the control group the markedly effective rate was 68.63% and 68.00% respectively, and effective rate was 90.20% and 90.00% respectively, no significant difference was found between the two groups (Pgt;0.05). For therapeutic effects on TCM syndromes, In the treatment group, the markedly effective rate was 71.70% and 74.00% respectively, and effective rate was 93.45% and 96.00 % respectively, while in the control group the markedly effective rate was 66.67% and 68.00% respectively, and effective rate was 89.22% and 90.00% respectively, also showed insignificantly difference (Pgt;0.05). No adverse effect was found in the observation. Conclusion JYBDG shows a definite clinical effect with no obvious toxic-adverse effects.
