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

NCT06243614 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 410

Last updated 2024-02-06

No results posted yet for this study

Summary

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

Conditions

  • Generalized Anxiety Disorder

Interventions

DRUG

Buagafuran capsules, 15mg/ capsule

Participants took 60-120 mg Buagafuran capsules daily. The initial dose was 60mg/ day, 2 to 4 capsules per time, twice per day, respectively, after breakfast and dinner for 8 weeks;

DRUG

Buspirone tablets, 5mg/ tablet

Participants took 10-20mg Buspirone tablets daily. The initial dose was 10mg/ day, 1 to 4 tablets per time, twice per day, respectively, after breakfast and dinner for 8 weeks.

DRUG

Buagafuran capsules mimic, 0mg/ capsule

Participants took Buagafuran capsules mimic daily. 2 to 4 capsules per time, twice per day, respectively, after breakfast and dinner for 8 weeks;

DRUG

Buspirone tablets mimic, 0mg/ tablet

Participants took Buspirone tablets mimic daily. 1 to 4 tablets per time, twice per day, respectively, after breakfast and dinner for 8 weeks.

Sponsors & Collaborators

  • R&G Pharma Studies Co.,Ltd.

    collaborator INDUSTRY

  • Beijing Union Pharmaceutical Factory Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-24
Primary Completion
2026-06-30
Completion
2027-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06243614 on ClinicalTrials.gov