3
Clinical Trials associated with ShuGanJieYuJiaoNang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.
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.
Shugan Jieyu Capsule for Insomnia Patients With Depressive Symptoms: A Randomized Double Blind Controlled Study
This study is a randomized, placebo-controlled, double-blind clinical study. 60 cases of insomnia patients with depressive symptoms are planned to be treated, and they are randomly assigned to the experimental group (Shugan Jieyu Capsule combined with zolpidem group) and the control group (placebo combined with zolpidem group) in equal proportion. Both groups are given zolpidem orally for basic treatment, with the treatment dose of 10mg per tablet per day, one tablet per time, once a day, before sleep, for 8 consecutive weeks. The test group was given Shugan Jieyu Capsule orally, with a therapeutic dose of 0.36g per capsule, 2 capsules each time, twice a day, and once after breakfast and dinner. The control group was given placebo orally, with a treatment dose of 0.36g per capsule, 2 capsules each time, twice a day, and once after breakfast and dinner. The therapeutic effect of Shugan Jieyu Capsule on insomnia patients with depressive symptoms was observed by analyzing the changes of ISI scores, subjective and objective sleep indicators (PSG, sleep diary), daytime cognitive function, autonomic nervous function and EEG after the intervention in the fourth and eighth weeks.
100 Clinical Results associated with ShuGanJieYuJiaoNang
100 Translational Medicine associated with ShuGanJieYuJiaoNang
100 Patents (Medical) associated with ShuGanJieYuJiaoNang
100 Deals associated with ShuGanJieYuJiaoNang