|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ChiCTR |
|
Last refreshed on:
|
11 December 2017 |
|
Main ID: |
ChiCTR-ONB-17013805 |
|
Date of registration:
|
2017-12-10 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Clinical Research on TCM Treatment of Ankylosing Spondylitis
|
|
Scientific title:
|
Clinical Research on TCM Treatment of Ankylosing Spondylitis |
|
Date of first enrolment:
|
2018-02-01 |
|
Target sample size:
|
Chinese medicine group and Western medicine group:180; |
|
Recruitment status: |
Pending |
|
URL:
|
http://www.chictr.org.cn/showproj.aspx?proj=23720 |
|
Study type:
|
Observational study |
|
Study design:
|
Before-After control
|
|
Phase:
|
New Treatment Measure Clinical Study
|
|
|
Countries of recruitment
|
|
China
| | | | | | | |
|
Contacts
|
|
Name:
|
Su Xiaojun
|
|
Address:
|
518 Guazhou Road, Qilihe District, Lanzhou, Gansu, China
730050
|
|
Telephone:
|
+86 13659473497 |
|
Email:
|
929782833@qq.com |
|
Affiliation:
|
Gansu Provincial Hospital of Traditional Chinese Medicine |
|
|
Name:
|
Su Xiaojun
|
|
Address:
|
518 Guazhou Road, Qilihe District, Lanzhou, Gansu, China
730050
|
|
Telephone:
|
+86 13659473497 |
|
Email:
|
929782833@qq.com |
|
Affiliation:
|
Gansu Provincial Hospital of Traditional Chinese Medicine |
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria: (1) meeting the diagnostic criteria of Western medicine;
(2) meeting the dialectical criteria of traditional Chinese medicine diagnosis;
(3) aged 18 to 50 years old;
(4) voluntarily participating in clinical research and signing informed consent form;
(5) The judgment criteria for the disease activity were BASDAI=4 and spine pain score =4;
(6) Approved by the Medical Ethics Committee of Gansu Provincial Hospital of Traditional Chinese Medicine: Sulfasalazine methotrexate , Leflunomide, to be discontinued after 1 month before entering the group; the use of biological agents need to be discontinued more than 3 months before enrollment; use of non-steroidal anti-inflammatory drugs, need to be discontinued after 2 weeks before enrollment.
Exclusion criteria: (1) those who do not meet the inclusion criteria;
(2) pregnant women or lactating women in pregnancy or in the near future;
(3) other seronegative spondyloarthropathies;
(4) patients with advanced spinal rigidity and severe joint deformities; ) With acute ophthalmia need corticosteroid treatment;
(6) those who can not tolerate the test drug;
(7) merger heart, cerebrovascular, liver, kidney and hematopoietic system and other serious primary diseases.
Age minimum:
52
Age maximum:
18
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Ankylosing spondylitis
|
|
Intervention(s)
|
|
Chinese medicine group and Western medicine group:Drug intervention;
|
|
Primary Outcome(s)
|
|
asessment in ankylosing spondylitis,ASAS;
|
|
Source(s) of Monetary Support
|
|
Gansu Provincial Hospital funded self-funded hospital
|
|
Ethics review
|
Status: Approved
Approval date: 10/11/2017
Contact:
Li yumei
+86 0931-2687005
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|