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临床试验/NCT01671124
NCT01671124Unknown不适用

Phase IIa Study of Antidepression Use Natural Plants Extracted of Soline Capsule.

Taipei Medical University Hospital1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2012年9月最近更新:
适应症

试验速览

阶段
不适用
入组人数
1
试验地点
1
主要终点
DSM-IV

研究概览

简要总结

Considering the potential modulatory effects of Salvia divinorum, Lycium, Chenpi and Dihuang supplementation on mood, this study is a clinical study of Soline® (product mixed with Salvia divinorum, Lycium, Chenpi and Dihuang ) supplementation to investigate the effect of attenuating the occurrence of depression. The study will enroll 100 patients who meet the inclusion and exclusion criteria. The trial will be concluded when a total of evaluable 80 patients (40 patients in each treatment group).

详细描述

Depression is one of the major metal disorders associated with symptoms such as regular negative moods, decreased physical activities, feeling of helplessness, and cognitive deficits. According to the seminal "burden of disease" study by World Health Organization (WHO) has predicted that by 2030 depression will be the second leading cause of disease. The Diagnostic and Statistical Manual of Mental Disorders (DSM) is the American Psychiatric Association's standard reference for psychiatry which includes over 400 different definitions of mental disorders. Selective and reversible monoamine oxidase inhibitor, selective serotonin reuptake inhibitors or serotonin and noradrenaline reuptake inhibitors are the typical antidepressants usually. Unfortunately, current drug therapies for depression are not ideal. Most of the drugs are synthetic nitrogen-bearing compounds which have inevitably some serious adverse-effects such as causing cardiovascular disease, insomnia and ovarian teratomas. Hence, there is an urgent need for the research and development of more effective antidepressants without any/ with minor adverse-effect. Up to the present, many Chinese medicinal plants have been successfully used to treat sentimental diseases, which is similar to depression in the Western medicine. Shamans of the Mazatec people of Oaxaca, Mexico have used Salvia divinorum for at least centuries in ethnomedical practices including spiritual healing and divinorum. Salvia divinorum contains the known psychoactive constituent salvinorin A, which is a trans-neoclerodancediterpenoid and a к-opioid agonist with no activity at the 5-HT2A serotonin receptor, making it an ideal agent for antidepressant. Salvia divinorum use occurring in Europe and Japan, and survey research suggests that user claim positive after-effects. Lycium, Chenpi ( Citrus reticulate Blanco ) and Dihuang ( Rehmannia glutinosa ) were widely used in the vast majority of Chinese medicine prescription to treat mental disease, for example, Lily Bulb Decoction to Preserve the Lung ( Lycium and Dihuang ) from Analytic Collection of Medical Formula , Spirit-quieting Decoction ( Chenpi ) form Restoring Health from Tens of Thousands of Diseases. Considering the potential modulatory effects of Salvia divinorum, Lycium, Chenpi and Dihuang supplementation on mood, this study is a clinical study of Soline® (product mixed with Salvia divinorum, Lycium, Chenpi and Dihuang ) supplementation to investigate the effect of attenuating the occurrence of depression.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of major depressive disorder

排除标准

  • Pregnancy and nursing
  • Schizophrenia spectrum disorder
  • Manic depressive disorder
  • Bipolar disorder
  • Anxiety Disorder
  • Abnormal biochemistry analysis value:( AST and ALT≧triple the upper limit of normal);
  • Serum creatinine>2mg/dl
  • BUN>40mg/dL
  • Total bilirubin>2.0mg/dL
  • Hematocrit<30
  • White blood count≧15000
  • High sensitivity to this product
  • The diseases will influence of results: pulmonary tuberculosis, uncontrolled diabetes, uncontrolled hypertension, serious infection and critical cardiovascular, liver, kidney disease.
  • Alcohol abuse or drug abuse
  • Attended the other study in last 4 weeks
  • Attempted suicide or self-injurious

结局指标

主要结局

DSM-IV

时间窗: Day 1 and up to 6 weeks

diagnosis of major depressive disorder according to DSM-Ⅳ has change

次要结局

  • analysis of inflammation cytokine(Day 1 and up to 6 weeks)
  • analysis of basic biochemical(Day 1 and up to 6 weeks)
  • Fatty acid composition(Day 1 and up to 6 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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