NCT05772104

Clinical Trial of Shugan Jieyu Capsule in Generalized Anxiety Disorder

A Multi-center, Randomized, Double-Blind Clinical Trial of Shugan Jieyu Capsule in Generalized Anxiety Disorder

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 495 (estimated)
• Sponsor: Sichuan Jishengtang Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized double-blind placebo-controlled phase 3 clinical trial to further validate the effectiveness and safety of Shugan Jieyu Capsules in treating generalized anxiety disorder.

Detailed description

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, 495 subjects were randomly assigned to the experimental and placebo groups at a ratio of 1:1.

Conditions

• Generalized Anxiety Disorder

Interventions

Type	Name	Description
DRUG	Shugan Jieyu Capsules	Oral, 4 Capsules, BID
DRUG	Shugan Jieyu Capsules Placebo	Drug: Shugan Jieyu Capsules Placebo, Oral，4 capsules，BID Drug: Placebo, Oral, 1 capsule, BID

Timeline

• Start date: 2023-04-17
• Primary completion: 2025-02-28
• Completion: 2025-06-01
• First posted: 2023-03-16
• Last updated: 2024-12-18

Locations

1 site across 1 country: China