Ygldg Treatment Of Chronic Cholecystitis Clinical Trials

Objective:Through observation chronic cholecystitus treatment around clinical symptomand B ultra inspection change situation, further observes the efficiency ofyangganlidan granule on patients of liver-yin deficiency syndrome. Through observesthe three routine experiments, the function of heart, liver and kidney and clinicaladverse event makes the further appraisal to its security, builds the foundation for it inthe clinical on promoted application.Methods:1. Experimental design:Uses the lamination block stochastically, the parallel comparison, double blind,the multi-central clinical test method.2. Experimental object:This research being selected 80 cases of illness, who originate completely fromthe Hubei Province Chinese medicine hospital outpatient service as well as in-patientand passed through the diagnosis for the chronic cholecystitus and liver-yin deficiencysyndrome in the Chinese medicine, divides into two groups stochastically, theexperimental group(60 examples), the control group (20 examples).3. Treatment planExperimental group: every patient takes yangganlidan Granule orally, 1 bag eachtime, 2 times every day, Simultaneously, takes huisanliu pieces (simulation medicinalpreparation) orally, 1 piece each time, 3 times every day. Control group: every patienttakes huisanliu pieces orally, 1 piece each time; 3 times every day, Simultaneously,Takes yangganlidan Granule (simulation medicinal preparation) orally, 1 bag eachtime, 2 times every day. Continuously takes medicine 4 weeks is 1 treatment course,subsequent visits on 1st week, 2nd week, 4th week. The viewing time is 1 treatmentcourse.4. The observation of treatment effectiveness:4.1 Improvement situation of Host sickness.4.2 Index of comprehensive curative effect.4.3 Phantom study (B ultra) curative effect determination.5. Secure target observation: 5.1 Blood, stool and urine routine experiment.5.2 Electrocardiogram, liver function (AST, ALT, ALP,г-GT, TBiL, DBiL), kidneyfunction (BUN, Scr).5.3 The type, degree, formation rate of clinical adverse event6. Data record and statistics:Carries on valid and the secure appraisal according to the curative effectobservation and the secure observation, after the experiment had finished carries onthe data input, finally carries on the data the statistical analysis.Results:1. Comparison of total curative effects between two groups of case of illness: Thetotal effectiveness of experimental group is 93％, The total effectiveness of controlgroup is 85％, after statistics processing, there is non-significance difference in totaleffectiveness between two groups(P＞0.05), it explained that there is similar curativeeffect between the experimental group and the control group.2. Comparison of the scores of every traditional Chinese medicine syndrome betweentwo groups of case of illness before and after being treated: Chinese medicinessymptom integral obviously reduce after two groups of case of illness being treated,the comparison has the significance difference with the treatment before (P＜0.05), itexplained two groups can improve the clinical symptom effectively. The symptomimprovement of experimental group surpasses the control group besides twosymptoms: aggravate after have feed greasy food and the distension of the abdomen.3. Comparison of the scores of total traditional Chinese medicine syndrome betweentwo groups of case of illness before and after being treated: The main symptom of twogroups has obviously improved after being treated. Group comparison P＞0.05, in thegroup compares P＜0.05, there isn't the significance difference between theexperimental group and the control group.4. Comparison of gallbladder B ultra between two groups of case of illness before andafter being treated: After statistics analysis, p＞0.05, it explained there isn'tsignificance in curative effect difference between two groups of case of illness beforeand after being treated, there is quite curative effect between two groups of case ofillness in B ultra.5. Comparison of adverse reaction between two groups of case of illness after beingtreated: In medication period, there is 1 person in the experimental group has had theabdominal pain, the control group takes medicine the period has 3 people to appear disgusting, there 1 person appears the skin rash, but the symptom is slight, does notprocess, so completes the treatment smoothly. After the x~2 test, there is significantdifference between experimental group and the control group (P＜0.05), it explainedthe adverse reaction of experiment group smaller obviously than the control group.Conclusion:Yangganlidan granule may obviously reduce clinical symptom and pathologicalchange degree, by the B ultra of the chronic cholecystitus patients of liver-yindeficiency. Compares with the control group, the difference of total effective does nothave the significance, it explained that there is same curative effect, between treatmentgroup and control group. In the course of treatment, there isn't affects obviously to theelectrocardiogram, three routine experiments, the function of liver and kidney, onlythen 1 person has the abdominal pain, the symptom is slight, does not process,lightens and reduces voluntarily, completes the treatment smoothly, so it explainedYangganlidan granule suits the Chinese medicine diagnosis and treatment theory totreatment of the chronic cholecystitus patients of liver-yin deficiency, Is one kind ofsecurity effective medicine.