MedDataX Logo

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

NCT ID: NCT03932006

Last Updated: 2019-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2019-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ankylosing Spondylitis

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

ankylosing spondylitis Fengshigutong Capsule imrecoxib

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Fengshigutong Capsule plus Imrecoxib

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

Group Type EXPERIMENTAL

Fengshigutong Capsule plus Imrecoxib

Intervention Type DRUG

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

Fengshigutong Capsule

Fengshigutong Capsule 1.2g twice a day,orally

Group Type EXPERIMENTAL

Fengshigutong Capsule

Intervention Type DRUG

Fengshigutong Capsule 1.2g twice a day,orally

Imrecoxib

Imrecoxib 0.1g twice a day,orally

Group Type ACTIVE_COMPARATOR

Imrecoxib

Intervention Type DRUG

Imrecoxib 0.1g twice a day,orally

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Fengshigutong Capsule plus Imrecoxib

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

Intervention Type DRUG

Fengshigutong Capsule

Fengshigutong Capsule 1.2g twice a day,orally

Intervention Type DRUG

Imrecoxib

Imrecoxib 0.1g twice a day,orally

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Gu Jieruo

Division of Rheumatology of Third Affiliated Hospital of Sun Yat-sen University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jieruo Gu, Prof

Role: STUDY_DIRECTOR

Rheumatology Department, the Third Affiliated Hospital of Sun Yat-sen University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Rheumatology Department, the Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Jieruo Gu, Prof

Role: CONTACT

Phone: +8620-85252055

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Jieruo Gu, Prof

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

[2015]2-159

Identifier Type: -

Identifier Source: org_study_id