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Clinical study of the correlation between disease activity and anxious depression in patients with ankylosing spondylitis

Evaluation of the effectiveness of Tongdu Shujin Decoction combined with Adamumab in the treatment of ankylosing spondylitis and the correlation between patients' disease activity and anxious depression

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300071418
Enrollment
Unknown
Registered
2023-05-15
Start date
2023-05-15
Completion date
Unknown
Last updated
2023-06-12

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

Conditions

Ankylosing spondylits

Interventions

Tongdu Shujin decoction group: Tongdu Shujin Decoction a dose per day + adalimumab 40mg subcutaneously injected every two weeks for 12 weeks.
Control group:Adalimumab was injected subcutaneously with 40mg every two weeks for 12 weeks.

Sponsors

The First Affiliated Hospital of Henan University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria. The inclusion criteria are as follows: (1) Meet the AS diagnostic criteria of 1984; (2) 18-40 of age, male or female; (3) Participation in the study was voluntary, and all patients signed informed consent forms.

Exclusion criteria

Exclusion criteria: The exclusion criteria are as follows: (1) Pregnant women, children, prisoners, and other vulnerable groups; (2) Patients with other serious illnesses that require treatment (such as blood diseases, tumors, etc.); (3) Patients with other rheumatic immune system diseases; (4) Patients with allergies to the study drug; (5) Patients had mental disorders and were unable to communicate with others.

Design outcomes

Primary

MeasureTime frame
Ankylosing Spondylitis Disease Activity Score;

Secondary

MeasureTime frame
The changes of IL-6, IL-17 and TNF-a in serum of patients;Changes of anxiety depression related scales HADS and PHQ-9 in patients;Changes of patients' pain scale McGill and fatigue scale FSS;

Countries

China

Contacts

Public ContactWen Fu

The First Affilliated Hospital of Henan University of Chinese Medicine

1129499199@qq.com+86 185 3924 6658

Outcome results

None listed

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