Suspended

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

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What is being collected

Data Collection

Collected from today forward - Prospective
Other
Who is being recruted

Mental Disorders+1

+ Depressive Disorder

+ Mood Disorders

From 20 to 60 Years
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: September 2012
See protocol details

Summary

Principal SponsorTaipei Medical University Hospital
Study ContactYu-Ru Guo, masterMore contacts
Last updated: September 11, 2012
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2012

Actual date on which the first participant was enrolled.

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.

Principal SponsorTaipei Medical University Hospital
Study ContactYu-Ru Guo, masterMore contacts
Last updated: September 11, 2012
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

1 patient to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 20 to 60 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Mental DisordersDepressive DisorderMood DisordersDepressive Disorder, Major

Criteria

Inclusion Criteria: •Clinical diagnosis of major depressive disorder Exclusion Criteria: 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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Taipei Mecical University Hospital

Taipei, TaiwanOpen Taipei Mecical University Hospital in Google Maps
SuspendedOne Study Center