Efficacy and safety of Wenbu Zhibi granule in patients with ankylosing spondylitis: a multicenter, randomized, double-blind, placebo-controlled trial

Phase 1

Recruiting

• Conditions: ankylosing spondylitis

• Registration Number: ITMCTR2100004482
• Lead Sponsor: The Affiliated Jiangnan Hospital of Zhejiang Chinese Medical University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Participants meeting the following requirement will be included.
(1) It is in accordance with as New York standard revised by American Society of Rheumatology in 1984;
(2) The diagnosis was in accordance with the New York criteria revised in 1984;
The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) was used to indicate the disease activity when the score was more than 4.
(3) Aged >= 18 years old and onset age <= 45 years old, both male and female;
(4) Sign informed consent and ensure the compliance of the experiment;
(5) Women of childbearing age were confirmed to have no pregnancy by testing, and there was no pregnancy plan during the whole trial period;
(6) There was no history of tuberculosis infection and active tuberculosis.

Exclusion Criteria

(1) Combined with other types of autoimmune diseases;
(2) Cancer and cancer patients;
(3) Patients with allergic constitution or allergic to the test drug or patients with serious adverse reactions after using the test drug;
(4) Lactation or pregnancy women;
(5) Patients with mania, depression and other mental disorders;
(6) People with a history of infectious diseases such as tuberculosis, hepatitis B and HIV carriers and other infectious diseases;
(7) Medical diseases with poor control, such as diabetes, hypertension and hyperlipidemia, etc;
(8) Those who had a history of opioid analgesics, sedative hypnotics and alcohol abuse;
(9) Combined with severe liver and kidney disease or severe damage of liver and kidney function;
(10) Patients with blood system diseases;
(11) Poor compliance, unable to meet the follow-up requirements.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the ASAS40 response rate;

Secondary Outcome Measures

Name	Time	Method
the ASAS5/6 response rate in patients;the ASAS partial remission response rate;the ASAS20 response rate;