Randomized Clinical Trial of Shugan Jieyu Capsule in Generalized Anxiety Disorder
Status:
Not yet recruiting
Trial end date:
2025-06-01
Target enrollment:
Participant gender:
Summary
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.