Phase 3 Randomized, Double-Blind Study of Shugan Jieyu Capsules for Treating Generalized Anxiety Disorder in Adults

What this Trial Is About

Researchers are evaluating Shugan Jieyu Capsules in a phase 3, multi-center, randomized, double-blind, placebo-controlled clinical trial for patients with generalized anxiety disorder GAD characterized by liver Qi stagnation and spleen deficiency syndrome in traditional Chinese medicine. The study aims to confirm the effectiveness and safety of this treatment in relieving anxiety symptoms. This trial includes an exploratory stage and a confirmatory stage to thoroughly assess the treatment outcomes. Participants are assigned to receive either Shugan Jieyu Capsules or a placebo, taking 4 capsules twice daily, once in the morning and once in the evening, with at least 8 hours between doses, for up to 12 weeks. The study is divided into two stages the first stage includes high-dose, low-dose, and placebo groups the second stage involves experimental and placebo groups with larger participant numbers. During the trial, researchers will monitor changes in anxiety levels using the Hamilton Anxiety Rating Scale HAM-A at multiple time pointsweeks 2, 4, 8, and 12as well as other assessments like quality of life and clinical global impressions. Safety and symptom improvements will be tracked closely through these evaluations, with the total participation period lasting up to 12 weeks.

Clinical Trial of Shugan Jieyu Capsule in Generalized Anxiety Disorder