NCT03932006

A Multicenter，Double-Blind and Randomized Controlled Trial of Fengshigutong Capsule in the Treatment of Ankylosing Spondylitis

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, double-blind, multicentral clinical trial to investigate the efficacy and safety of Fengshigutong Capsule in the treatment of active ankylosing spondylitis(AS). The primary purpose is to assess the different maintaining treatment programme in AS patients with controlled inflammation by Imrecoxib. The trial will include 180 patients who will be divided into three group: Fengshigutong Capsule plus Imrecoxib group, Imrecoxib group and Fengshigutong Capsule group. Patients will complete the 4-week therapy.

Conditions

• Ankylosing Spondylitis

Interventions

Type	Name	Description
DRUG	Fengshigutong Capsule plus Imrecoxib	Fengshigutong Capsule 1.2g twice a day,Imrecoxib 0.1g twice a day,orally
DRUG	Fengshigutong Capsule	Fengshigutong Capsule 1.2g twice a day,orally
DRUG	Imrecoxib	Imrecoxib 0.1g twice a day,orally

Timeline

• Start date: 2016-06-30
• Primary completion: 2019-05-31
• Completion: 2019-05-31
• First posted: 2019-04-30
• Last updated: 2019-04-30

Locations

1 site across 1 country: China