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| ID | Type | Description | Link |
|---|---|---|---|
| SFDA-2006L03870 |
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| Name | Class |
|---|---|
| Nanjing Medical University | OTHER |
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The main objective of this study is to evaluate the effectiveness and safety of the propionyl-L-carnitine hydrochloride tablets among Chinese population in comparison with the placebo, for treatment of the peripheral arterial diseases (intermittent claudication) with oral supplementation of 2g daily for a 4 months continuous administration.
This is a randomized, multi-centre, double-blind and placebo controlled clinical study. Propionyl-L-Carnitine (PLC) is a kind of natural derivative of L-Carnitine (LC) and is produced in the body and concentrated by 90% in the skeletal muscle and myocardium via an enzyme-mediated reaction involving propionyl-CoA and LC. For oral adminsitration, PLC shows that the decrease of the leg muscle carnitine of the PAD patient appears to correlate with poor exercise performance. It has recently been shown that the severity of the impairment in walking distance is correlated with the impairment in carntine metabolism at the muscle level. 2g daily of PLC supplementation can significantly improve the walking ability in patients with IC with a maximum walking capacity between 50 and 250 meters on the treadmill.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propionyl-L-carnitine Tablets | Drug | 500mg tablets, oral administration of 2g daily |
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| Measure | Description | Time Frame |
|---|---|---|
| To compare the difference between pre-and post-the treatment of each group | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Statistically describe the variance of ABI, CT and other indexes at the end of 4th month | 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jianxin Li, MD | Xuanwu Hospital, Beijing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuanwu Hospital Capital Medical University | Beijing | Beijing Municipality | 100053 | China |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |