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A Randomized, Parallel-controlled, Clinical Study to Evaluate the Efficacy of Xuebi Prescription Compared With Placebo in the Treatment of Diabetic Peripheral Neuropathy(Qi Deficiency and Blood Stasis)
Charged by the sponsor in line with traditional Chinese medicine Qi deficiency and blood stasis syndrome 60 cases have DPN,they were randomly divided into Chinese herbal compound Xuebi prescription group and placebo group. The treatment groups were compared 24-week composite score.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Xuebi formula | Experimental | Xuebi formula , one dosage ,every day, treat 6 months. |
|
| Placebo | Placebo Comparator | placebo,has the same taste and color as Xuebi formula one dosage ,every day, treat 6 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xuebi formula | Drug |
| ||
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Scores of TCM clinical symptom and the clinical scoring system of Toronto (TCSS) |
| 24weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Nerve conduction velocity | Nerve conduction velocity are recorded at 0,12th,24th weeks. | 24Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events | Adverse events with records at any time. | 24Weeks |
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| qiang zhou, PHD | Contact | 15101016416 | 0086 | 15101016416@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiaolin Tong, PHD | Guang'anmen Hospital | Study Chair |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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