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

The Affiliated Jiangnan Hospital of Zhejiang Chinese Medical University0 个研究点开始时间: 待定最近更新: 2023年2月20日

试验速览

暂无简介。

•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.

•(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.

发起方

The Affiliated Jiangnan Hospital of Zhejiang Chinese Medical University