Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| No. BWS11J067 | Other Grant/Funding Number | Scientific Research Funds Project of Chinese PLA |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to access the effect (week 12/week 24) of puerarin injection on carotid intima-media thickness (CIMT) in rheumatoid arthritis (RA) patients despite routine anti-rheumatic treatment.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Puerarin injection 400 mg | Experimental | Patients were administrated with 400 mg intravenously infused puerarin injection once a day. Puerarin injection was prepared in 250 mL 0.9% sodium chloride injection before the use. The treatment course consisted of 2 weeks followed by a 15-day interval for 24 weeks. Furthermore, patients receive stable treatment with oral anti-rheumatic agents and/or non-steroidal anti-inflammatory drugs, prednisone, aspirin, statins, bone metabolism regulators and gastric mucosal protective agents on as-needed basis. |
|
| Control | Sham Comparator | Patients receive routine anti-rheumatic care only. Patients receive stable treatment with oral anti-rheumatic agents and/or non-steroidal anti-inflammatory drugs, prednisone, aspirin, statins, bone metabolism regulators and gastric mucosal protective agents on as-needed basis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Puerarin injection 400 mg | Drug | Patients receive treatment with oral anti-rheumatic agents and/or non-steroidal anti-inflammatory drugs, prednisone, aspirin, statins, bone metabolism regulators and gastric mucosal protective agents on as-needed basis.Furthermore, patients were administrated with 400 mg intravenously infused puerarin injection once a day.Each treatment course lasted for 2 weeks followed by a regular time interval of 15 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline in Carotid intima-media thickness at 24 weeks | Carotid intima-media thickness (CIMT) was using a high-resolution B-mode ultrasound machine (iU22 xMATRIX, Philips, Germany). CIMT was measured twice by a single experienced operator using an 10-MHz linear vascular probe. Patients were let resting in a relaxed supine position, with the head turned gently to the contralateral side when the electrocardiogram was recorded. The imaging system (QLab 6.0, Philips, Germany) was applied to measure the CIMT signals from the proximal internal carotid artery (the arterial segment 10 mm distal to the carotid bifurcation), the carotid bulb and the distal common carotid artery (the arterial segment 10 mm proximal to the carotid bulb). The mean CIMT was calculated from the value of five arterial segments. All the measurement and analysis procedures were performed by a single ultra sonographer and a single reader, who were blinded to patient profiles and group assignment. | At 0 week, 12 weeks, 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| low-density lipoprotein cholesterol (LDL-C) | at 0 week, 12 weeks, 24 weeks | |
| erythrocyte sedimentation rate (ESR) | at 0 week, 12 weeks, 24 weeks | |
| C reactive protein (CRP) |
| Measure | Description | Time Frame |
|---|---|---|
| Kidney function | from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 weeks | at 0 week, 12 weeks, 24 weeks |
| Liver function |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Min Yang, Ph.D. | General Hospital of Chengdu Military Area Command PLA | Principal Investigator |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30245282 | Derived | Yang M, Luo Y, Liu T, Zhong X, Yan J, Huang Q, Tao J, He Q, Guo M, Hu Y. The Effect of Puerarin on Carotid Intima-media Thickness in Patients With Active Rheumatoid Arthritis: ARandomized Controlled Trial. Clin Ther. 2018 Oct;40(10):1752-1764.e1. doi: 10.1016/j.clinthera.2018.08.014. Epub 2018 Sep 21. |
Not provided
Not provided
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D050197 | Atherosclerosis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C033607 | puerarin |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Control | Drug | Patients receive treatment with oral anti-rheumatic agents and/or non-steroidal anti-inflammatory drugs, prednisone, aspirin, statins, bone metabolism regulators and gastric mucosal protective agents on as-needed basis |
|
|
| at 0 week, 12 weeks, 24 weeks |
| Total cholesterol (TC) | at 0 week, 12 weeks, 24 weeks |
| triglycerides (TGs) | at 0 week, 12 weeks, 24 weeks |
| tumor necrosis factor (TNFα) | at 0 week，12 weeks, 24 weeks |
| interleukin-8 (IL-8) | at 0 week，12 weeks, 24 weeks |
| interleukin-1 (IL-1) | at 0 week，12 weeks, 24 weeks |
| interleukin-6 (IL-6) | at 0 week，12 weeks, 24 weeks |
| disease activity score in 28 joints (DAS28) | at 0 week，12 weeks, 24 weeks |
| homeostasis model assessment (HOMA-IR) | at 0 week，12 weeks, 24 weeks |
from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 weeks
| at 0 week, 12 weeks, 24 weeks |
| blood cell count | from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 weeks | at 0 week, 12 weeks, 24 weeks |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |