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This study is a multicenter, randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of Yuxuebi tablet in treating night pain of Ankylosing Spondylitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Yuxuebi tablet | Experimental | take 5 tablets once, 3 times a day, for 42(±3)days. |
|
| Placebo tablet | Placebo Comparator | take 5 tablets once, 3 times a day, for 42(±3)days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Yuxuebi tablet | Drug | 0.5g/ tablet |
| |
| Placebo tablet |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Visual analogue scale (VAS) for night pain | Baseline, at day 7, day 14, day 28, day 42 during treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Visual analogue scale (VAS) for whole day | Baseline, at day 7, day 14, day 28, day 42 during treatment | |
| BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) | Baseline, at day 28, day 42 during treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guang'anmen Hospital | Beijing | China |
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| ID | Term |
|---|---|
| D013167 | Spondylitis, Ankylosing |
| ID | Term |
|---|---|
| D000089183 | Axial Spondyloarthritis |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
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| Drug |
0.5g/ tablet |
|
| BASFI (Bath Ankylosing Spondylitis Functional Index) | Baseline, at day 28, day 42 during treatment |
| BASMI (Bath Ankylosing Spondylitis Metrology Index) | Baseline, at day 28, day 42 during treatment |
| Syndrome score of traditional Chinese medicine | The Evaluation Scale of Syndrome score ranges from 0 (best score) to 15 (worst score). | Baseline, at day 28, day 42 during treatment |
| SF-36 (The Medical Outcomes Study 36-item short-form health survey) | Baseline, at day 42 during treatment |
| ESR (Erythrocyte Sedimentation Rate) | Baseline, at day 14, day 28, day 42 during treatment |
| CRP (C-Reactive Protein) | Baseline, at day 14, day 28, day 42 during treatment |
| The First People's Hospital of Guangzhou | Guangzhou | China |
|
| The First People's Hospital of Jinzhong | Jinzhong | China |
|
| Nanchong Central Hospital | Nanchong | China |
|
| Shenzhen Traditional Chinese Medicine Hospital | Shenzhen | China |
|
| D013122 |
| Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D000844 | Ankylosis |
| D007592 | Joint Diseases |
| D001168 | Arthritis |