| Objective:1.Verify "Jia Wei San Xiang Tang" granule clinical curative effect for the treatment of functional abdominal distension.2. Study on the mechanism of the intestinal mottlity in the treatment of FB with "Jia Wei San Xiang Tang".Mothods:This paper collected a total of 45 patients. It is a randomized, double-blind, placebo-based study. The set of standard for①Conforms to the FB standard of Western medicine diagnosis and Liver-depression and Spleen-deficiency Syndrome.②At the age of 18-60 years old.③ This study was done on volunteers who provide informed consent Before clinical trials begin, by the test personnel do not participate in, according to the syndrome type stratified random number identified by the group for the drug design of packaging, including Traditional Chinese medicine group and placebo group. Both of them were taken twice a day (8:00am,8:00pm) for 21 days. Symptoms index, symptoms and gastrointestinal transit time (GITT),the changes of abdominal circumference and quality of life were observed. On the zeroth day to observe the symptoms and GITT and abdominal circumference. Patients completed the quality of Life Weekly. Statistical analysis of SPSS 19.0 software. The count data of two groups were compared by chi square test or Fisher test T test is used to measure the normal distribution of the measured data. Non parametric sign test for the non normal distribution of measurement data. Comparison of curative effect Measurement data using t test If the variance is not homogeneous, then the t’test is used Count data using x2 test Rank sum test in non parametric test of rank data. Safety evaluation:T test was used to compare the two groups of quantitative data in laboratory tests.Result:In 45 cases,37 cases were completed Experimental group 22 cases, control group 15 cases, shedding 6 cases. The average age of the patients was 48±17 years.14 cases were male,23 females. Complete GITT test in 25 cases. The symptom score, abdominal circumference, quality of life score data is normal distribution. GITT index is not normal distribution. Baseline data:54%of FB patients had GITT abnormalities. GITT patients with 45%FB is a normal range. Symptom aspects:The abdominal distension symptoms and other digestive tract symptoms in the experimental group were significantly unproved compared with the control group FB. The aspects of GITT and abdominal circumference change:Compared with the control group, the GITT in the experimental group was significantly better than that in the conirol group. Two groups of abdominal circumference were not significantly unproved Changes in quality of life:Compared with the control group, the digestive tract related adverse mood of the experimental group was significantly improved compared with the control group. During the course of the experiment, no adverse events and adverse reactions were found.Conclusion:1. Jia Wei San Xiang Tang can improve the symptoms of patients, including abdominal distension and other gastrointestinal symptoms, and can improve the quality of life of patients.2. Wei San Xiang Tang Jia can promote patients with intestinal motility, improve the intestinal motility may be an important mechanism for the efficacy of.3. Most of the patients had abnormal intestinal motility, which showed the lack of intestinal motility, but the abnormal intestinal motility was not the only mechanism of FB.In short, Jia Wei San Xiang Tang had a good effect in the treatment of FB of symptoms, GITT, abdominal circumference, quality of life. The study by GITT, abdominal circumference two objective to study monitoring treatment efficacy and mechanism of traditional Chinese medicine in the treatment of FB, to obtain the consistent results, there are some innovative. |
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