Objective: To observe the curative effect and safety of Tianren Pingchuan capsule in treatment of chronic obstructive pulmonary disease (deficiency of pulmonary and renal vital energy). Method: A design of randomized

placebo-controlled

double-blind trial was adopted. The 120 cases of chronic obstructive pulmonary disease were selected and randomly divided into treatment group and control group

with 60 cases in each group respectively. The best western medical therapy solution was applied to both groups

on which basis Tianren Pingchuan capsules and placebo capsules was used respectively. Three times a day

3 capsules each time and total daily dose of 450 mg.The course of treatment was 24 weeks. Tranditional Chinese medicine (TCM) syndromes

st. George vespiratory questimnaire scores(SGRQ)

6 minute walk test(6MWT)

pulmonary function

cases and safety index of acute re-exacerbation were observed. Result: Curative effect of TCM syndromes: the total efficacious rate in treatment group and control group was 89.28% and 60.34% respectively

with statically significant differences (P<0.01)

improvement of TCM syndromes: In both groups

the scores and total scores for cough

expectoration

anhelation and chest distress after treatment were lower than those before treatment (P<0.01); score changes in treatment group were superior to that in control group (P<0.05). Life quality and exercise tolerance: after 24-week treatment

SGRQ score in treatment group obviously decreased with remarkable improvement of 6MWT distances (P<0.01); SGRQ score in treatment group and 6MWT distances were better than those in control group (P<0.05). Cases of acute re-exacerbation: the incidence of acute re-exacerbation in treatment group and control group was 5.36% (3/56) and 20.68% (12/58) respectively

with statically significant differences (P<0.05). Conclusion: Tianren Pingchuan capsules can improve ventilation function for chronic obstructive pulmonary disease (deficiency of pulmonary and renal vital energy)

with remarkable efficacy and satisfactory safety.