The Clinical Study Of Effectiveness And Safety Of Gaodijiangzhi Capsules In Treating Primary Hyperlipemia

Objective:To observe the GaoDiJiangZhi Capsule to adjust the efficacy and safety of primary dyslipidemia.Methods:144 patients with primary dyslipidemia were enrolled from China academy of traditional Chinese medicine Xiyuan hospital,the first affiliated hospital of Tianjin medical university,the second affiliated hospital of Tianjin medical university,Liaoning university second affiliated hospital of traditional Chinese medicine,combined Chinese and western medicine hospital of Jilin province,Heilongjiang university second affiliated hospital of traditional Chinese medicine.They were randomly divided into experimental group and control group After 12 weeks of treatment,observe the main curative effect:Treatment for 12 weeks,the baseline variation rate of total cholesterol(TC)in the serum.The secondary indices needed to be observed include(1)the baseline variation rate of TQLDL-C,HDL-C,ox-LDL,apoA,apoB,Lp(a)and VLDL-C in plasma in the 12th week;(2)After 12 weeks,We observed the curative effect of HLP,record the symptoms' change of TCM and normal physiology,for the symptom and safety analysis.Results:According to the data of full analysis set,for decreasing rate of TC in the 12th week,P<0.05,the two groups have signif-icant difference.For decreasing rate of TC in the 4th and 8th week,P>0.05,the two groups have no significant difference.Treatment group has efficacy treatment to decrease total cholesterol(TC)compared with control group.In the treat groups,showed better curative effect in treating symptoms of TCM,the signs had changed much better than before took the capsules.The total effective percentage was 81.7%,there was significant difference between two groups(P<0.05).Two groups has efficacy treatment to decrease total cholesterol(TC),triglyceride(TG),low density lipoprotein(LDL)and very low density lipoprotein(VLDL),there was significant difference.During treating,there is no serious side effect and no deaths to the patient's health in both the treated group and the controlled group.Conclusion:In this multi-central clinical trial,GaoDiJiangZhi capsule has a credible curative effect in treating patients with Hyperlipidemia.It is a satisfied Chinese medicine in curing hyperlipidemia.There no serious side effect is founded during the clinical researeh.The ultimate conclusion still depends on further confirmation by amplifying samples' clinical trial.