| Research Objective: rapid development and change, fierce competition and increasing pressure of modern society result in the incidence of depression has increased steadily in recent years, showing high momentum. According to statistics, the global depression patients have exceeded 300 million, our country is close to 90 million only. Depression has become an "epidemic." emotional mental disease. However, there is still no complete theory was formed in reason and mechanism of depression in Western Medicine There are some disadvantages, such as slow effectiveness, loe efficiency, high recurrence rate, in clinical treatment.In recent years, along with the deepening of Chinese medicine treatment research on depression, some achievements have been gained. The Morinda oligosaccharides capsule independently research and developed by Beijing Tong Ren Tang Co., caught the ‘Yang deficiency ’ feature that half of patients with depression show decreasing attention, interest and other psychological engineering symptoms aims to treat mild to moderate depression caused by kidney deficiency syndrome. After the pre-test and three pharmacological studies, by tonifying kidney from start to improve symptoms of depression, recovering patients’ mental function the efficacy and safety of Morinda oligosaccharides capsule are validated in the clinical trial on treatment of the kidney yang deficiency type depression.This paper belongs to a Morinda Oligosaccharides Capsules clinical trial in patients at stage IV with 2400 cases. 80 cases were selected in outpatients complying with deficiency type mild depression inclusion criteria for a period of eight weeks of Morinda oligosaccharides capsule drug test. 0 days to 8th weekend of observation data were analyzed to further verify safety and efficacy of Morinda oligosaccharides capsule in treatment of deficiency type mild depression.Research Methods: 80 cases in Preventive Treatment Department in Shanxi Medical College Hospital were selected according to the deficiency type mild depression inclusion and exclusion criteria set in experimental scheme. Morinda oligosaccharides capsule drug clinical trials for a period of eight weeks were conducted In patients were informed and agreements were signedFrom the starting point of treatment(day 0) to the end of treatment(week 8) visits were paid every two weeks, five times visits in all. The Hamilton Depression Rating Scale(HAMD17), Hamilton Anxiety Scale(HAMA), TCM deficiency syndrome score on the score sheet were applied to assessing the effect of treatment. In the second weekend visits, decision on whether to maintain the initial dose or increase dose was made based on treatment and medication plan. When the 8th weekend trial ended, visit data were summarized. The data were compared before and after treatment. Statistical analysis was conducted : First is the efficiency analysis in accordance with the end of treatment(week 8) HAMD17 TCM deficiency and validity of the score sheet; the third is a summary of adverse reactions occurred in the test, according to laboratory tests results changes in safety analysis conducted before and after treatment.The result: to set the 8th weekend as the end of the test. analysis of the results compared by each visits data and baseline data for comparative are as follows:1. HAMD17 of the 8th weekend total score minus 12.01 ± 3.37, reduced rate 58.2 ± 16.02. t-test P <0.05, there are significant differences within the group before and after treatment. After 8 weeks of treatment efficiency is 83.75%(67/80), before and after treatment statistics P <0.05, χ2 analysis significantly.8 weekend TCM deficiency syndrome score sheet total minus score 14.39 ± 4.43, reduced rate 65.32 ± 15.72. t-test P <0.05, there are significant differences within the group before and after treatment. Each visit data were given statistical description using(composition ratio); before and after treatment using the χ2 test. After 8 weeks of treatment efficiency is 85%(68/80), before and after treatment statistics P <0.05, χ2 analysis significantly.8 weeks total score minus 11 ± 3.62, reduced rate 64.3 ± 19.23. t-test P <0.05, there are significant differences within the group before and after treatment. Each visit data were given statistical description using(composition ratio); before and after treatment using the χ2 test. After 8 weeks of treatment efficiency of 78.75%(63/80), before and after treatment statistics P <0.05, χ2 analysis significantly.Laboratory tests and ECG showed no significant difference betweeen 0 day and 8th weekend. 15 cases of drug treatment-related adverse reactionswere found, nine cases were in increments treatment group, 6 patients were in the normal dose group. The main adverse effects of high doses of the test drug group were dry mouth(6%), constipation(6%), dizziness(4%), nausea(2%) and low-dose group were nausea(3.33%), dry mouth(6.75%), dizziness(3.33%), constipation(3.33%), fatigue(3.33%), the degree should be mild.Conclusions: The clinical trial design is an open arm, good results were confirmed by comparison before and after treatment the Morinda deficiency type oligosaccharides capsule treatment of mild depression, efficiency is 83.75%. Meanwhile, it also has a therapeutic effect on anxiety symptoms associated with mild depression, efficiency is 78.75%.Morinda oligosaccharides capsule has good therapeutic effect for kidney yang deficiency type mild depression, fear, insomnia, fatigue, chills, loss of libido, tinnitus, forgetfulness, TCM symptoms less gas lazy words, palpitations and so, the effective rate is 85%.Throughout the course of the experiment, there were 15 cases treatment-related adverse reactions, adverse reactions were mild that the patient can tolerate, no special treatment needed, no effect on patient recovery. There were influnces on the further treatment and clinical trials of medication no healthy damage was caused to subjects, indicating safety of the drug.. |
PDF Full Text Request