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A randomized, open-label , positive drug controlled (Neurotropin,Japan organs Pharmaceutical Co., Ltd. ), multi-center study to evaluate Analgecine's efficacy and safety for the treatment of neuropathic pain.
The study was designed to evaluate the efficacy and safety of Analgecine for the treatment of neuropathic pain for 2 weeks. It was a randomized, open-label , positive drug controlled, multi-center study phase III clinical trial. Patients were recruited with age between 18 and 80 and visual analysis scale (VAS) between 3 and 8. After randomization, subjects were divided into 2 groups: 1) Treatment with Analgecine as experiment group; 2) Treatment with Neurotropin as positive control group. There are 3 measurement time points on day 0, 7, 14 after treatment to score patients pain with VAS. The changes of the VAS score at day 14 were compared between groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Analgecine | Experimental | 3ml, 2 times per day, continuous infusion for two weeks. |
|
| Neurotropin | Active Comparator | 3ml, 2 times per day, continuous infusion for two weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Analgecine | Biological | Extraction from rabbit skin extract through vaccinia virus inoculation inflammation as an antigen immune reaction. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of visual analog scale on pain | Pain was scored by VAS 10 points (visual analog scale). The degree of pain gradually increases from 0 to 10. The subtraction mark rate of VAS value before and after treatment and the grade decrease of associated symptoms will be regarded as the main curative effects indexes. | 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lu-Ning Wang | Chinese PLA General Hospital | Study Director |
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| ID | Term |
|---|---|
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
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| ID | Term |
|---|---|
| C010491 | neurotropin |
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| Neurotropin | Biological | a natural bio-product obtained from rabbit skin extract through vaccinia virus inoculation inflammation as an antigen immune reaction. |
|
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |