RecruitingPhase 3NCT06243640

Phase 3 Clinical Trial of Buagafuran Capsules in the Treatment of GAD

Safety and Efficacy of Buagafuran Capsules in the Treatment of Generalized Anxiety Disorder: a Multi-center, Randomized, Double-blind, Double-dummy, Placebo-controlled, Positive-controlled, Fixed-dose Phase Ⅲ Clinical Trial


Sponsor

Beijing Union Pharmaceutical Factory Ltd

Enrollment

504 participants

Start Date

Jul 25, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

A placebo-controlled superiority design was used to evaluate the efficacy of 60 mg/ day or 120 mg/ day of Buagafuran capsules in the treatment of GAD


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This Phase 3 clinical trial is testing Buagafuran capsules — a potential new treatment for generalized anxiety disorder (GAD) — to confirm whether it is effective and safe. GAD is a condition where people experience excessive, difficult-to-control worry about everyday events for most days over at least six months. **You may be eligible if...** - You are between 18 and 65 years old - You have been formally diagnosed with generalized anxiety disorder (GAD) - Your anxiety is severe enough to need medication - You are seen as an outpatient (not hospitalized) - You are willing and able to participate in the full trial **You may NOT be eligible if...** - You have serious depression in addition to anxiety (depression score above 17) - You have a high suicide risk - Your anxiety improved significantly between screening and baseline (20% or more reduction in score) - You are currently in another drug clinical trial - You have major heart, liver, or kidney problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBuagafuran capsules, 15mg/ capsule

Subjects took Buagafuran capsules; twice per day, respectively, after breakfast and dinner for 8 weeks;

DRUGBuagafuran capsules mimic, 0mg/ capsule

Subjects took Buagafuran capsules mimic. twice per day, respectively, after breakfast and dinner for 8 weeks;


Locations(1)

Beijing Union Pharmaceutical Factory Ltd

Beijing, Beijing Municipality, China

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NCT06243640


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