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

Ankylosing Spondylitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03932006
• Other study ID #: [2015]2-159
• Status: Recruiting
• Phase: Phase 4
• Start date: June 30, 2016
• Est. completion date: May 31, 2019

Study information

• Verified date: April 2019
• Source: Sun Yat-sen University
• Contact: Jieruo Gu, Prof
• Phone: +8620-85252055
• Email: gujieruo[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: May 31, 2019
• Est. primary completion date: May 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Spondylitis
• Spondylitis, Ankylosing

Intervention

Drug:
• Fengshigutong Capsule plus Imrecoxib
Fengshigutong Capsule 1.2g twice a day,Imrecoxib 0.1g twice a day,orally
• Fengshigutong Capsule
Fengshigutong Capsule 1.2g twice a day,orally
• Imrecoxib
Imrecoxib 0.1g twice a day,orally

Locations

Country	Name	City	State
China	Rheumatology Department, the Third Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the proportions of patients reaching Assessment in Ankylosing Spondylitis 20%	ASAS20 was defined as an improvement of =20% and absolute improvement of =1 unit (0-10-cm VAS) from baseline in =3 of the following 4 domains (and absence of deterioration in any domain): patient's global assessment of disease activity (PTGA), pain assessment (mean of total and nocturnal pain scores), Bath Ankylosing Spondylitis Functional Index (BASFI), and clinical inflammation (mean of 2 morning stiffness-related scores on the BASDAI)	4 week
Secondary	the proportions of patients reaching Assessment in Ankylosing Spondylitis 50%	defined as 20% improvement in 5 of the following 6 domains: PTGA, pain assessment, BASFI, clinical inflammation, spinal mobility, and C-reactive protein (CRP)	4 week
Secondary	ASAS20 response	ASAS20 was defined as an improvement of =20% and absolute improvement of =1 unit (0-10-cm VAS) from baseline in =3 of the following 4 domains (and absence of deterioration in any domain): patient's global assessment of disease activity (PTGA), pain assessment (mean of total and nocturnal pain scores), Bath Ankylosing Spondylitis Functional Index (BASFI), and clinical inflammation (mean of 2 morning stiffness-related scores on the BASDAI)	4 week
Secondary	ASAS5/6 response	defined as 20% improvement in 5 of the following 6 domains: PTGA, pain assessment, BASFI, clinical inflammation, spinal mobility, and C-reactive protein (CRP)	4 week