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

Sun Yat-sen University

Status and phase: Unknown; Phase 4

Conditions: Ankylosing Spondylitis

Treatments: Drug: Fengshigutong Capsule; Drug: Imrecoxib; Drug: Fengshigutong Capsule plus Imrecoxib

Study type: Interventional

Funder types: Other

Identifiers

NCT03932006

[2015]2-159

Details and patient eligibility

About

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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 to 65 years
• Meet 1984 modified New York criteria for AS
• The Bath AS Disease Activity Index (BASDAI) ≥4 on a 0-10-cm visual analog scale or the Ankylosing Spondylitis Disease Activity Score using the C-reactive protein level (ASDAS-CRP) ≥1.3
• NSAIDs washout period of at least 7 days prior to randomization
• DMARDs washout period of at least 4 weeks prior to randomization
• Corticosteroids washout period of at least 2 weeks prior to randomization
• Biological agents washout period of at least 3 months prior to randomization.

Exclusion criteria

• Peptic ulcer
• Unstable cardiac diseases
• Hematologic disorders
• Psychosis
• Malignancy
• Multiple sclerosis
• severe COPD
• fibromyalgia and other rheumatic disease
• Corticosteroids were injected into the articular cavity within 3 months
• Chinese medicine was taken within 28 days
• Pregnant and lactating women
• Alcohol and drug abuse
• Spinal cord compression

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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180 participants in 3 patient groups

Fengshigutong Capsule plus Imrecoxib

Experimental group

Description:

Fengshigutong Capsule 1.2g twice a day,Imrecoxib 0.1g twice a day,orally

Treatment:

Drug: Fengshigutong Capsule plus Imrecoxib

Fengshigutong Capsule

Experimental group

Description:

Fengshigutong Capsule 1.2g twice a day,orally

Treatment:

Drug: Fengshigutong Capsule

Imrecoxib

Active Comparator group

Description:

Imrecoxib 0.1g twice a day,orally

Treatment:

Drug: Imrecoxib