[Translation] A multicenter, randomized, double-blind clinical trial of Shugan Jieyu Capsule in the treatment of generalized anxiety disorder (liver depression and spleen deficiency syndrome)

探索不同剂量舒肝解郁胶囊用于广泛性焦虑障碍（肝郁脾虚证）的有效性和安全性，筛选出一个获益/风险比最优的剂量组，并对目标人群和用药疗程进行探索，指导第二阶段确证性研究设计。第二阶段：进一步验证舒肝解郁胶囊（4 粒，BID）治疗广泛性焦虑障碍的有效性和安全性。

[Translation]

Explore the efficacy and safety of different doses of Shugan Jieyu Capsules for generalized anxiety disorder (liver depression and spleen deficiency syndrome), screen out a dose group with the best benefit/risk ratio, and explore the target population and medication course to guide the design of the second phase of confirmatory research. Phase II: Further verify the efficacy and safety of Shugan Jieyu Capsules (4 capsules, BID) in the treatment of generalized anxiety disorder.

Start Date24 Sep 2024

Sponsor / Collaborator

Sichuan Jishengtang Pharmaceutical Co., Ltd.

ITMCTR2024000099 / RecruitingIIT

Clinical and Mechanism Study of Shugan Jieyu Capsule in intervention of ACS and Depression

Start Date15 Jun 2024

Sponsor / Collaborator

Xiyuan Hospital of China Academy of Chinese Medical Sciences

CTR20230577 / CompletedPhase 2/3

舒肝解郁胶囊治疗广泛性焦虑障碍（肝郁脾虚证）多中心、随机、双盲临床试验

[Translation] A multicenter, randomized, double-blind clinical trial of Shugan Jieyu Capsule in the treatment of generalized anxiety disorder (liver depression and spleen deficiency syndrome)

第一阶段：探索不同剂量舒肝解郁胶囊用于广泛性焦虑障碍（肝郁脾虚证）的有效性和安全性。第二阶段：进一步验证舒肝解郁胶囊治疗广泛性焦虑障碍的有效性和安全性。

[Translation]

Phase I: Explore the effectiveness and safety of different doses of Shugan Jieyu Capsule for generalized anxiety disorder (liver depression and spleen deficiency syndrome). Phase II: Further verify the effectiveness and safety of Shugan Jieyu Capsule in treating generalized anxiety disorder.

Start Date17 Apr 2023

Sponsor / Collaborator

Sichuan Jishengtang Pharmaceutical Co., Ltd.

100 Clinical Results associated with ShuGanJieYuJiaoNang

100 Translational Medicine associated with ShuGanJieYuJiaoNang

100 Patents (Medical) associated with ShuGanJieYuJiaoNang

Literatures (Medical) associated with ShuGanJieYuJiaoNang

01 Aug 2024·Journal of Psychiatric Research

Efficacy and safety of Chinese patent medicines combined with antidepressants for treatment of depression in adults: A multiple-treatment meta-analysis

Article

Author: Yi, Lidan ; Cui, Wei ; Peng, Liubao ; Li, Sini ; Li, Jianhe ; Peng, Ciyan ; Chen, Jing

BACKGROUNDCombinations of Chinese patent medicines (CPM) with antidepressants (including selective serotonin reuptake inhibitors (SSRI), selective serotonin-norepinephrine reuptake inhibitors (SNRI), tricyclic antidepressants (TCA), and noradrenergic and specific serotonergic antidepressants (NaSSA)) are frequently utilized for treating depression in adults. However, the efficacy and safety of these combination treatments remain to be established.METHODSSystematic search was conducted in seven electronic databases, regulatory websites and international registers of trials from 1994 to 2023 that included adult patients with depressive disorders who received CPM combined with antidepressants. The Multiple-Treatment Meta-Analysis (MTMA) was conducted using a random effects model with Stata/MP17 and R4.3.5 software. Primary outcomes were total efficacy rate, Hamilton Depression Scale (HAMD) score, and Treatment Emergency Symptom Scale (TESS) score. Secondary outcomes included brain-derived neurotrophic factor (BDNF) levels.RESULTSA total of 146 randomized controlled trials (13,754 participants: 6929 in intervention and 6825 in control groups) were included. For total effective rate, Multiple-Treatment Meta-Analysis results showed that the overall effect of combined intervention was better compared with antidepressants alone, where Jieyuanshenkeli (JYASKL) presented the optimal option for improving total efficacy (OR = 5.39, 95% CI [2.60, 11.18], SUCRA = 84.50%). In reduding the HAMD, Shuganjieyujiaonang (SGJYJN) was most likely to reduce the HAMD score (SMD = -2.20, 95% CI [-3.06, -1.33], SUCRA = 86.10%), Jieyuanshenkeli (JYASKL),Tianewangbuxindan (TWBXD), Shuyukeli (SYKL), Anshenbuxinwan (ASBXW) combination intervention did not appear to be statistically superior to antidepressants alone. In theTreatment Emergency Symptom Scale (TESS), Wulinjiaonang induced the most significant reduction in TESS score (SMD = -1.98, 95% CI [-3.59, -0.36], SUCRA = 90.40%). Tianmengjiaonang (TMJN) + Antidepressants(AD) (SUCRA = 88.30%) displayed the highest scores in increasing the levels of BDNF, although not statistically significant compared to Antidepressants(AD) alone (SMD = 1.23, 95% CI [0.90, 1.55]).CONCLUSIONCombinations of CPM and antidepressants showed superior efficacy over antidepressants alone. The optimal combinations were determined as Shuganjieyu Jiaonang (SGJYJN)/SSRIs and Jieyuanshenkeli (JYASKL)/SSRIs. In terms of safety, results showed that combination therapy did not show better TESS efficacy than antidepressants alone.Although some of the combination interventions were not superior than antidepressants alone in reducing HAMD scores,our findings provide a potentially significant alternative option for clinical complementary therapy. However, these results require further validation through larger sample sizes, multicenter randomized controlled trials, and real-world data.

100 Deals associated with ShuGanJieYuJiaoNang

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Depressive Disorder	CN	Chengdu Kanghong Biotechnology Co. Ltd.	20 Oct 2008

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Generalized anxiety disorder	Phase 3	CN	Sichuan Jishengtang Pharmaceutical Co., Ltd.	17 Apr 2023

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