舒肝宁神滴丸(Shugan Ningshen Dropping Pills) - 在研适应症：入睡和睡眠障碍_专利_临床

概要

基本信息

药物类型

中药

别名-

靶点-

作用机制-

治疗领域

神经系统疾病

在研适应症

入睡和睡眠障碍

非在研适应症-

原研机构-

在研机构

山西省中医药研究院（山西省中医院）北京凯晋科技有限公司

非在研机构-

最高研发阶段临床3期

首次获批日期-

最高研发阶段(中国)临床3期

特殊审评-

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关联

2

项与舒肝宁神滴丸相关的临床试验

CTR20150600 / Recruiting临床3期

评价舒肝宁神滴丸治疗失眠症（肝郁气滞型）有效性及安全性的随机双盲、平行对照、多中心临床研究

1、确证舒肝宁神滴丸治疗失眠症（肝郁气滞型）有效性及安全性。2、观察舒肝宁神滴丸治疗失眠症（肝郁气滞型）的临床应用的安全性。

开始日期2016-06-14

申办/合作机构

山西省中医药研究院（山西省中医院）

[+1]

CTR20130685 / Completed临床2期

评价舒肝宁神滴丸治疗失眠症有效性和安全性的随机双盲、安慰剂平行对照、多中心Ⅱ期临床试验

初步探索及评价舒肝宁神滴丸治疗失眠症（肝郁气滞型）有效性及安全性。

开始日期2012-03-31

申办/合作机构

山西省中医药研究院（山西省中医院）

[+1]

100 项与舒肝宁神滴丸相关的临床结果

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100 项与舒肝宁神滴丸相关的转化医学

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100 项与舒肝宁神滴丸相关的专利（医药）

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5

项与舒肝宁神滴丸相关的文献（医药）

2024-04-26·Medicine

Effect of acupuncture combined with Ningshen mixture on climacteric insomnia: A randomized controlled trial

Article

作者: Cai, Yan ; Zhang, Xiaodan ; Yang, Wei ; Li, Jiaying

Background:In recent years, the incidence of menopause insomnia has gradually increased, seriously affecting women's physical and mental health.Methods:Total 82 climacteric insomnia patients received from January 2021 to January 2023 were divided into 2 groups at random. In control group, 41 cases received conventional Western medicine, and in study group, 41 cases received acupuncture combined with Ningshen mixture. Clinical effectiveness of both groups was compared, neurotransmitter levels, TCM syndrome integral and Pittsburgh Sleep Quality Index (PSQI) were assessed in both groups. Meanwhile, the recurrence rate and safety were evaluated in 2 groups.Results:The curative effect in study group was better than that in control group (P < .05). After treatment, the expressions of 5-hydroxytryptamine and β-endorphin (β-EP) in study group were higher than control group (P < .05); TCM syndrome scores and PSQI scores in study group were lower than control group (P < .05). The total recurrence rate in study group was obviously lower than control group at 3 months after treatment (P < .05). There were no serious adverse reactions in both group, and no distinct difference between 2 groups was found (P > .05).Conclusion:Acupuncture united with Ningshen mixture has a significant therapeutic effect and high safety in climacteric insomnia patients. It can effectively improve the neurotransmitter levels, clinical symptoms and sleep quality, and reduce the recurrence rate of climacteric insomnia patients, which has high clinical application value and is worthy of clinical promotion.

2024-04-01·Journal of Ethnopharmacology

The safety evaluation of Shenze Shugan capsule and mechanism of apoptosis induced by five potentially nephrotoxic components

Article

作者: Wang, Bei ; Qiu, Zhidong ; Xu, Jie ; Fan, Meiling ; Ding, Hongyue ; Wang, Xin ; Huang, Qiang ; Wang, Yuqi ; Yu, Xinmiao ; Liu, Bo ; Ji, Fenglan ; Yao, Fan

ETHNOPHARMACOLOGICAL RELEVANCEShenze Shugan capsule is a prescription of traditional Chinese medicine for nonalcoholic steatohepatitis treatment. It includes Rhei Radix et Rhizoma (RR), Cassiae Semen (CS) and Alismatis Rhizoma(AR), which widely contains rhein, emodin, aurantio-obtusin, alisol A and alisol B 23-monoacetate.AIM OF THE STUDYIn this study, we aimed to explore the safety of the medicine, and further elucidate the mechanism of apoptosis induction in HK-2 cells by five components, including rhein, emodin, aurantio-obtusin, alisol A and alisol B 23-monoacetate.MATERIALS AND METHODSWe investigated the nephrotoxicity of Shenze Shugan capsule, including RR, CS, AR and mixed herbs given for two months in rats. Superoxide dismutase (SOD) in kidney tissues, urea nitrogen (BUN) and creatinine (CRE) in serum were detected, and renal pathology analysis was performed. In cell experiments, the apoptotic rate and cell cycle distribution of HK-2 cells were tested by flow cytometry. The levels of mitochondrial membrane potential (ΔΨm) and related protein expression in mitochondrial pathway were measured as well.RESULTSWe confirmed that two months of administering high doses(60 times the dose for clinical use in adults) of RR, CS or mixed herbs upregulated the levels of CRE and RUN, inhibited SOD activity, and increased the degree of tubular degeneration and glomerular dilatation, but Shenze Shugan capsule has no significant differences in renal structure or renal function. In addition, we found that five components all concentration-dependently inhibited HK-2 cells proliferation and induced apoptosis, especially aurantio-obtusin as the novel nephrotoxic component. Rhein and emodin significantly induced S/M accumulation, but aurantio-obtusin, alisol A and alisol B 23-monoacetate significantly induced G1/M accumulation in HK-2 cells. Similarly, they could induce Caspase3 activation, loss of mitochondrial membrane potential (ΔΨm), and down-regulation of Bcl-2 and up-regulation of Bax.CONCLUSIONSThrough a two-month subchronic toxicity study in rats, our preliminary determination is that this formulation is safe and reliable for long-term use. Interestingly, the potentially toxic herbs such as RR, CS, AR can reduce toxicity by drug compatibility. When further exploring the mechanism of action of toxic herbs, we found that mitochondrial pathway is involved in the apoptosis of HK -2 cells induced by rhein, emodin, aurantio-obtusin, alisol A and alisol B 23-monoacetate. Our findings provide new ideas for safety studies of Shenze Shugan capsule.

2022-09-01·Alternative therapies in health and medicine

Efficacy and Safety of the Bushen-Shugan Method in Pregnancy Outcomes in Patients with Recurrent Miscarriage Complicated by Anxiety and Depression: A Prospective Randomized Trial.

Article

作者: He, Meijuan ; Ding, Xuelei ; Fu, Zijie ; Hu, Zhexia ; Cang, Rong ; Gao, Yu ; Tian, Zan ; Ma, Saihua ; Xia, Tian

ObjectiveThis study aimed to investigate the effect of the Bushen-Shugan (BSSG) method on pregnancy outcomes, serum D-dimer (D-D), platelet aggregation rate, homocysteine (Hcy) and antithrombin III (AT-III) in patients with recurrent miscarriage complicated by anxiety and depression.MethodsFrom December 2016 to December 2019, 100 patients with recurrent miscarriage combined with anxiety and depression were enrolled in our study, and a prospective randomized trial was carried out. Patients were randomly assigned to either the control group or the BSSG group via the random number table method. Traditional Chinese medicine (TCM) syndrome scores, laboratory indicators and psychological changes were compared in the 2 groups before and after treatment.ResultsAfter treatment, the primary, secondary and total TCM syndrome scores in the 2 groups were lower, and the scores in the BSSG group were significantly lower than in the control group. The clinical curative effect in the BSSG group was significantly higher (92% vs 76%) than in the control group. The levels of β-HCG, P, E2 and AT-III in the 2 groups were higher, while levels of D-D, platelet aggregation rate and Hcy were lower than before treatment. The Self-rating Anxiety Scale (SAS) and Self-rating Depression Scale (SDS) scores were lower after treatment in both groups, and the scores in the BSSG group were significantly lower than in the control group.ConclusionsThe BSSG method may be worthy of consideration because it improves pregnancy outcomes in patients with recurrent miscarriage complicated by anxiety and depression.

100 项与舒肝宁神滴丸相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
入睡和睡眠障碍	临床3期	中国	北京凯晋科技有限公司	2016-06-14
入睡和睡眠障碍	临床3期	中国	山西省中医药研究院（山西省中医院）	2016-06-14