The Study of Antidepressant Properties and Safety of Fer-01(Soline®) on the Patients With Depression
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).
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Phase IIa Study of Antidepression Use Natural Plants Extracted of Soline Capsule.|
- DSM-IV [ Time Frame: Day 1 and up to 6 weeks ] [ Designated as safety issue: Yes ]diagnosis of major depressive disorder according to DSM-Ⅳ has change
- analysis of inflammation cytokine [ Time Frame: Day 1 and up to 6 weeks ] [ Designated as safety issue: Yes ]Laboratory examination parameters ( TNF-a,IL-6, TGF-b1)
- analysis of basic biochemical [ Time Frame: Day 1 and up to 6 weeks ] [ Designated as safety issue: Yes ]The incidence of hepatic and renal adverse events(GOT, GTP, BUN, creatinine...)
- Fatty acid composition [ Time Frame: Day 1 and up to 6 weeks ] [ Designated as safety issue: Yes ]Fatty acid composition is measure with gas chromatography.
|Study Start Date:||September 2012|
|Estimated Study Completion Date:||November 2013|
|Estimated Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
Salvia divinorum, Lycium, Chenpi and Dihuang
Other: Soline capsule
Other Name: prozac
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01671124
|Taipei Mecical University Hospital||Recruiting|
|Taipei, Taiwan, 100|
|Contact: Yu-Ru Guo, master 886227361661 ext 6549 firstname.lastname@example.org|
|Sub-Investigator: Chih-Chiang Chiu, Ph.D|
|Sub-Investigator: Hsin-Chien Lee, Ph.D|
|Principal Investigator: Shih-Yi Huang, Ph.D|
|Principal Investigator:||Shih-Yi Huang, Ph.D||Taipei Medical University|