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Efficacy and Safety of Kunxian Capsule in Treatment Patients With Early Ankylosing Spondylitis

NCT00953979 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2012-01-19

No results posted yet for this study

Summary

This is a prospective randomized controlled study to evaluated the efficacy and safety of kunxian capsule in treating of patients with early ankylosing spondylitis (AS). The major outcome index is proportion of patients achieving ASAS20 response at week12, and minor outcome indexes include ASAS50 and ASAS70, BASDAI20,BASDAI50 and BASDAI70. The adverse events at any time were recorded to evaluate the safety.

Conditions

Interventions

DRUG

kunxian capsule

The main element of kunxian capsule is Tripterygium. Patients should take 2 tablets per time and 3 times per day for 12 weeks.

Sponsors & Collaborators

  • China-Japan Friendship Hospital

    collaborator OTHER

  • Dongguan People's Hospital

    collaborator OTHER_GOV

  • Zhujiang Hospital

    collaborator OTHER

  • Huashan Hospital

    collaborator OTHER

  • Gu Jieruo

    lead OTHER

Principal Investigators

  • Jieruo Gu, M.D. · Rheumatology Department, Third Affiliated Hospital of Sun Yat-sen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2009-09-30
Completion
2009-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT00953979 on ClinicalTrials.gov