Clinical Study(phase III) on the Effecs of Jiangu Granula in Primary Osteoporosis

Objective:To observe the efficacy and safety of JianGu Granula in the treatment of the primary osteoporosis(traditional chinese medicine' syndrome of insufficient of liver and kidney) based on Clinical Study(phaseⅡ).Methods: The randomized,double-blind and compared with masc-medicine methods were adopted,96 primary osteoporosis(TCM' syndrome of insufficient of liver and kidney) patients were divided into the experiment group(72 patiants treated with JianGu Granula two bags once,twice a day) and the control group(24 patiants treated with GuSongbao Granula two bags once,twice a day).The duration of treatment of both groups was six months.Results: Results showed that the bone mineral density(BMD) of lumbar vertebra increased in both two groups after treatment,but the BMD of neck of femur in experiment group increased higher than that of control group,there was significant difference between two groups(P0.05).In curative effect of osteoporosis aspects: the effective rate was 80.4% in experient group,and 80.0% in control group,indicating no statistical difference in comparison(P0.05).In curative effect of traditional chinese medicine' symptom aspects: the effective rate was 97.8% in experient group,and 100% in control group,indicating no statistical difference in comparison(P0.05).There were no cases with toxic-side effects in experient group,and the rate of that was 6.25% in control group(P0.05).Conclusions: The clinical effects of treatment with JianGu Granula in OP were confirmed.In range of oral-administrative dosage and indication,JianGu Granula is the safe and effective drug for primary osteoporosis.