Study On The Effectiveness Of Clinical Trial Of Antiulcer Capsule

Duodenal ulcer(DU),a frequently-occurring disease in China,belongs to the common peptic ulcer.Periodic and rhythmic upper abdominal recurrent pain is a characteristic of chronic duodenal ulcers,often occurring in spring and winter.The incidence of males is higher than that of females.Abnormal gastric acid secretion,H.pylori infection,non-steroidal anti-inflammatory drugs(NSAIDs),irregular living and diet patterns,stress from work and environment,smoking,alcohol consumption,and psychosocial factors are all associated with the morbidity.The symptom of duodenal ulcer is called "epigastric pain" in Chinese medicine.The symptoms of the onset of disease include sthenia syndrome and heat syndrome which are regarded as the representation of blood stasis syndrome in Chinese medicine(syndrome of blood stasis and heat accumulation).Inflammatory manifestations,such as hyperemia and edema,can be observed around the ulcers under the gastroscope.Sometimes the ulcers will even bleed.Panax notoginseng saponins,Alkaloid of Daemonorops margaritae(Hance)Becc,Rhizoma Bletillae polysaccharide,celandine alkaloids and other effective components composed of the antiulcer capsule studied in the experiment.The curative effects include heat-clearing and damp-drying,elimination of blood stasis,muscle growth,gastric pain relieving and others effects.The syndrome of blood stasis and heat accumulation of Duodenal ulcer is the main indications of the antiulcer capsule.The epigastric pain,acid regurgitation,incandescence,bitter taste and thirst are symptoms of expression of DU.In the preclinical study of antiulcer capsule,pharmacological and toxicological experiments were carried out.Besides,Phase ?,Phase ? and Phase ? b clinical tolerance test have been conducted to determine the test dose of the antiulcer capsule.The randomized,open-label,parallel-design,multicenter clinical test method is adopted in the study for studying out the Phase ? c clinical trials based on the results of curative effect of Phase ?,Phase ? and Phase ? b and without abnormal reaction.It further determines the curative effect of the antiulcer capsule on the ulcer healing of patients with duodenal ulcer(syndrome of blood stasis and heat accumulation)and improve the effect of TCM syndrome score with 40 subjects.The Phase ? c clinical trial of the antiulcer capsule is studied out under a certain sample size of 40 cases.The value of curative effect of ulcer in the combination therapy group is better than that in the positive control group under the gastroscope,but the test results show that the curative effects of ulcer in different centers have significant differences.The eradication rate of Hp was not observed in the combination group and the positive control group.Besides,there is no difference between the eradication rate of Hp,the negative rate of 13C/14C-urea breath test and the negative rate of rapid urease test in gastric mucosa.However,the value of the eradication rate of Hp,the negative rate of 13C/14C-urea breath test and the negative rate of rapid urease test in gastric mucosa in the combination group were higher·than that in the positive control group.Compared with the curative effect(pain disappear rate)on epigastric pain in the positive control group,the combination group has the certain trend of efficacy;Difference between the TCM Syndromes curative effect was not observed in the combination group and the positive control group while treating the duodenal ulcer(syndrome of blood stasis and heat accumulation).However,the curative effect of the single symptom of traditional Chinese medicine(eructation and sour regurgitation)between the positive control group and the the combination group was statistically significant.The antiulcer capsule has passed the Phase ?,Phase ?,Phase ? b clinical trials confirmed the efficacy in the treatment of duodenal ulcer and the dose of test.The test is proposed for the further exploration of the clinical efficacy of the antiulcer capsule on duodenal ulcer(syndrome of blood stasis and heat accumulation).At the same time,it also provides the test basis for the listing of antiulcer capsule.