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

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

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2100004482
Enrollment
Unknown
Registered
2020-12-16
Start date
2021-01-01
Completion date
Unknown
Last updated
2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ankylosing spondylitis

Interventions

Sponsors

The Affiliated Jiangnan Hospital of Zhejiang Chinese Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
the ASAS40 response rate;

Secondary

MeasureTime frame
the ASAS5/6 response rate in patients;the ASAS partial remission response rate;the ASAS20 response rate;

Countries

China

Contacts

Public ContactRenfu Quan

The Affiliated JiangNan Hospital of Zhejiang Chinese Medical University

quanrenfu@126.com+86 13336021097

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026