• The Journal of Internal Korean Medicine
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• v.35 no.2
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• pp.145-156
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• 2014

Objectives : The aim of this study was to compare Tianwangbuxin-dan to Fluoxetine for antidepressive efficacy and safety in poststroke depression (PSD). Methods : A randomized, double blinded, non-inferiority trial was conducted. 113 PSD patients were recruited from a stroke center. Except for the 25 excluded patients, 88 PSD patients were randomly given either Tianwangbuxin-dan 1100 mg or Fluoxetine 20 mg per a day for 16 weeks. PSD was evaluated using Beck's depression inventory (BDI) and Hamilton depression rating scale (HDRS) and followed every fourth week. Repeated measure analysis of variance (ANOVA) was used to compare and contrast the depression scores of the two groups and to compare them among the evaluation times, at the beginning, $4^{th}$, $8^{th}$, $12^{th}$ and $16^{th}$ weeks. In addition, independent t-tests were used to find the difference between two groups at every evaluation time. Results : Finally, 88 PSD patients were included in the study, 63 PSD patients completed the procedure and 25 PSD patients were dropped out by the incompliance or withdrawal of consent. Tianwangbuxin-dan (or Fluoxetine) improved the depression of stroke patients and the efficacy of Tianwangbuxin-dan was not inferior to that of Fluoxetine. In addition, there was no significant side effect in two groups. Conclusions : This study showed that antidepressive efficacy and safety of Tianwangbuxin-dan in PSD patients.

• The Korea Journal of Herbology
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• v.38 no.2
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• pp.1-7
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• 2023

Objectives : From this study, we sight to identify Anti-stress effect of Chenwangbosim-Dan (Tianwangbuxin-Dan) Extract∘Fermented Rice Extract (GABA : gamma-aminobutyric acid 30%) Complex Methods : In order to measure the degree of functional evaluation of tension relief due to stress, it was evaluated whether the psychological indicators VAS(Visual Analog Scale) and POMS(Profile Of Mood State) were improved. Which is generally used for stress measurement and has a high frequency of clinical use. All clinical trial subjects were required to take the drug once a day at 9 ± 30 min in the morning for 2 weeks. Results : After intake, the group that Chenwangbosim-Dan(Tianwangbuxin-Dan) Extract∘Fermented Rice Extract (GABA : gamma-aminobutyric acid 30%) Complex had a statistically significant improvement effect compared to before intake due to an improved 30.81% of the VAS scores. The POMS-T score improved 54.13%, the POMS-V score improved 117.5% and the POMS-F score improved 59%, which had a statistically significant effect compared to Placebo group (p<0.001). There is a significant difference between two group, so even considering the placebo effect, the anti stress effect was confirmed in the Chenwangbosim-Dan (Tianwangbuxin-Dan) Extract∘Fermented Rice Extract (GABA : gamma-aminobutyric acid 30%) Complex intake group. Conclusions : The above results showed that the Chenwangbosim-Dan(Tianwangbuxin-Dan) Extract∘Fermented Rice Extract (GABA : gamma-aminobutyric acid 30%) Complex had an anti-stress effect. Therefore, it is expected to be developed as a safe and comfortable mental care health functional food that can reduce the risk of drug abuse.

• Journal of Oriental Neuropsychiatry
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• v.29 no.4
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• pp.267-280
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• 2018

Objectives: The objective of this study was to provide clinical evidence to support the use of a herbal medicine (Cheonwangbosim-Dan/Tianwangbuxin-Pellet (TWBXP)) for insomnia. Methods: Randomized controlled trials that verified effects of Herbal Medicine (Cheonwangbosim-Dan, Tianwangbuxin-Pellet) treating primary insomnia were carried out. A literature search of English, Chinese, Korean databases was also performed. The selected literature were assessed by Risk of Bias (RoB). Results: The total number of selected trials was 13 RCTs. Among the 13 RCTs, 10 were meta-analyzed. The Chinese Classification of Mental Disorders-3 (CCMD-3) was frequently used as the diagnostic criteria for interventions during the analysis of the use of herbal medicine (Cheonwangbosim-Dan/Tianwangbuxin-Pellet) for management of primary insomnia. As for outcome measurement, the effective rate was used. From the Meta-analysis of the studies, it was established that the insomnia cure effective rate in the TWBXP group was higher than that in the Western Medicine (WM) group (RR: 1.15, 95% CI: 1.07 to 1.24, p<0.0001, $I^2=33%$). Also, the effective rate in the TWBXP+ACU group was significantly different compared to the WM group (RR: 1.32, 95% CI: 1.13 to 1.54, p=0.0004, $I^2=0%$). The quality of the selected RCTs was low. Conclusions: Herbal medicine (Cheonwangbosim-Dan/Tianwangbuxin-Pellet) is effective for treating primary insomnia. It is worth noting that this studies were of relatively poor quality. The sample sizes were also small. Therefore, further investigations into the diagnosis and treatment of insomnia are warranted.

• Journal of Oriental Neuropsychiatry
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• v.21 no.2
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• pp.103-123
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• 2010

Objectives : This study was to investigate the effect of several herbal prescriptions such as Tianwangbuxindan qu zhusha, Tianwangbuxindan, Wendantang, Guipitang on the level of $MT_1$ and $MT_2$ melatonin receptors in C6 glial cells. Methods : For this study, we exposed of C6 cells to several herbal prescriptions resulted in non-cytotoxic in various dose as measured by MTT assay, trypan blue count, morphology change and DAPI stain. Results : Tianwangbuxindan qu zhush and Tianwangbuxindan induced the levels of $MT_1$ melatonin receptor expression in a dose-dependent manner without altering the level of $MT_2$ melatonin receptor expression. However, the treatment with Wendantang, Guipitang don't effect of $MT_1$ and $MT_2$ melatonin receptor expression. Conclusions : This results suggest that Tianwangbuxindan can be a promising the regulation of melatonin receptor synthesis, and further studies will be needed to clarify the mechanism.

• Journal of Oriental Neuropsychiatry
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• v.21 no.4
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• pp.137-149
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• 2010

Objectives : The aim of this study was to describe the clinical aspects in dementia outpatients who visited oriental neuropsychiatry clinic and to analyze the efficacy of herbal medicine. Methods: We analysed medical records of dementia outpatients who visited oriental neuropsychiatry clinic of K medical center from August. 2000 to July, 2010 and matched our criteria. Results: Ninety-two subjects were selected for analysis and consisted of 77.3% dementia of Alzheimer type. 13.0% vascular dementia. and 9.8% mixed type of dementia. Herbal medicine prescribed mainly were Jowjseungchung-tang(Tiaowejshengqing-tang). Kunneo-tang(Jjannao-tang) and Chenwangbosim-dan(Tianwangbuxin-dan) for dementia of Alzheimer type, and Sunghyangjungki-san(Xjngxjangzhengqi-san) and Upung-dan (Yufeng-dan) for vascular dementia. Scores of K-DRS were not changed for some subs cales and decreased but less than natural decline of Alzheimer disease. Score on the Memory subscale in group of Kunneo-tang(Jjannao-tang) increased significantly. Conclusions : These results suggest that the herbal medicine may be effective for dementia. More prospective studies are needed to assess the efficacy and prognosis of herbal medicine for dementia. Clinical guideline is needed for systematic data accumulation.