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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.CN |
First Approval Date29 May 2018 |
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Drug Highest PhasePhase 2 |
First Approval Ctry. / Loc.- |
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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] Multi-center, randomized, double-blind clinical trial of Shugan Jieyu Capsules in the treatment of generalized anxiety disorder (syndrome of liver depression and spleen deficiency)
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 1: To explore the efficacy and safety of different doses of Shugan Jieyu Capsules for generalized anxiety disorder (syndrome of liver depression and spleen deficiency).
The second stage: further verify the efficacy and safety of Shugan Jieyu Capsules in the treatment of generalized anxiety disorder.
A Multi-center, Randomized, Double-Blind Clinical Trial of Shugan Jieyu Capsule in Generalized Anxiety Disorder
This trial was a multi-center, randomized, double-blind, two-stage clinical trial in patients with generalized anxiety disorder (TCM differentiated as liver Qi stagnation and spleen deficiency syndrome), consisting of a exploratory study(stage 1) and a confirmatory study(stage 2).
In stage 1, 120 subjects were enrolled and randomly assigned to high-dose group, low-dose group and placebo group at a ratio of 1:1:1.
In stage 2, 440 subjects (final sample size was re-estimated based on the results of stage 1) were randomly assigned to the experimental and placebo groups at a ratio of 1:1.
A Multicenter Clinical Study to Evaluate the Efficacy and Safety of Shuganjieyu Capsule Combined With Fluoxetine in the Treatment of Depression
This study mainly evaluates the efficacy and safety of Shuganjieyu capsule combined with Fluoxetine as well as the Fluoxetine monotherapy for the treatment of depression in the basic study, and also explores the efficacy for the extended study period as well as the efficacy and safety for the full trial period (basic study period and extended study period).
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