OBJECTIVETo prove the effect of Kesuning Granule (KSNG) in treating chronic bronchitis in exacerbation (Phlegm-Heat syndrome) and objectively evaluate its safety.

METHODSThe double-blinded, double-dummy and randomized controlled method was adopted to observe 120 patients, who were divided into the treated group (n = 60, treated with KSNG 8 g, three times a day) and the control group (n = 60, treated with Jinbei Tankeqing Granule (JBTKQ) 7 g, three times a day). The therapeutic course for both groups was 6 days.

RESULTSIn the treated group, the markedly effective rate was 58.33% and effective rate was 93.33%, while in the control group, they were 51.67% and 91.67% respectively, no significant difference was found between the two groups. For therapeutic effects on TCM syndromes, the markedly effective rate and effective rate in the treated group was 68.33% and 93.33% respectively and in the control group, 66.67% and 90.00% respectively, also showed insignificant difference. The effect initiative time was earlier in the treated group than that in the control group significantly (P < 0.05). No adverse effect was found in the observation.

CONCLUSIONKSNG shows a definite clinical effect with no obvious toxic-adverse effects.