Ke I Capsule Treatment Of Hyperlipidemia In Clinical Studies

Objective:To investigate the clinical curative effect and safety of KeYu Capsule in Patients with hyperlipemia through clinical trial study,and to establish the substructure of directions to clinical medication.Methods:According to《Principle to clinical research of the traditional Chinese medicine therapia to hyperlipemia》,adopted randomization,double blindness,placebo medicine control of equal rank method was used in this trial selected 48 suitable cases whom were parted two groups at random,patients in trial group was treated with KeYu Capsule,while control group was treated with placebo.8 weeks was a course of treatment.We observed the curative effect of HLP,record the symptoms' change of TCM and signs' of HLP,lever of TC,TG,HDL-C,LDL-C were observed before and after treatment meanwhile.1.Select patients(1) The symptoms Correspond with the diagnostic criteria which this project establishs and the symptoms of phlegm muddy repressing,and accepting the informed consent.(2) Essential hyperlipide.(3) Although the patient had taken medicine to hyperlipemia, he has discontinuated for above twe weeks.(4) The age was among 18-70.2.Delete patients:(1) One suffered acute myocardial infarction;cerebrovascular accident;Severity trauma;major operation etc in half of one year.(2) Pregnancy or women in lactation;hypersensitiveness constitution or hypersens- itiveness to this drug.(3) Hamilial hypercholesterolemia or hyperlipemia revoked by nephrotic syndrome;hypothyroidism;arthrolithiasis;acute or chronicity liver and gall disease;urophthisis etc.(4) Hyperlipemia revoked by medicine such as dibenzothiazine;β-block agent;adrenal cortical steroid;some contraceptives etc.Patients was taking liquemine.(5) Medicine to thyropathy or other medicine which could effect lipid metabolism.Patients had accepted any other measure to subdue blood-fat.(6) Combinning with severity primary disease such as liver, kidney or hematopoietic system disease;psychotic.3.Grouping principle:48 suitable cases was were parted two groups:trial group and control group according to the table of random digit.4.Treatment project:Trial group was treated with KeYu Capsule,2 pills,third daily.Control group was treated with placebo,2 pills,third daily. 8 weeks was a course of treatment.5.Observation index:(1) Therapeutic efficiency observation:the curative effect of HLP,record the symptoms' change of TCM and signs' of HLP,lever of TC,TG,HDL-C,LDL-C.(2) Safety observation:the blood-routine,the urine-routine, the stool-routine,electro- cardiogram,liver function, kidney function.Results:(1) After 8 weeks,the KeYu Capsule has significant effects in symptom remission.There was significant difference between two groups(P<0.05).There was no significant difference between two groups in dease effect.The trail group can decrease the level of TC,and there was significant difference with the control group.The change of lever of TG,LDL-C,HDL-C has no statistically significant difference in group comparison(p>0.05).(2) Safety analysis:There were no untoward reactions in both trial group and control group in the clinical test.Conclusions:In this clinical trial,it was confirmed that the KeYu Capsule was effective and safe prescription in curing hyperlipemia (syndrome of stagnation of phlegm and sludging of Blood).