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The purpose of the study is to evaluate the efficacy on overall neuropathic sensory symptom improvement of Thioctacid tablet 600mg once daily vs. placebo in 6-weeks' treatment in Chinese diabetic patients with distal symmetric polyneuropathy (DSP).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Thioctacid Oral Placebo Tablet | Placebo Comparator |
| |
| Thioctacid Oral Tablet | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lipoic acid | Drug | Tablet, 600mg, for oral use, 30 min before breakfast, once daily for 6 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the efficacy on overall neuropathic sensory symptom improvement of Thioctacid tablet 600mg once daily vs. placebo in 6-weeks' treatment in Chinese diabetic patients with distal symmetric polyneuropathy (DSP) | Changes from baseline in Total Symptom Score (TSS) from week 1 to week 6 will be computed and summarized in an Area Under the Curve (AUC). | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate each sensory symptom improvement of Thioctacid tablet 600mg once daily vs. placebo in 6-weeks' treatment in Chinese diabetic patients with DSP | Changes in the individual symptom scores of the TSS (Stabbing pain, burning, paraesthesia, numbness) | 6 weeks |
| To evaluate onset time of Thioctacid tablet 600mg once daily vs. placebo in 6-weeks' treatment in Chinese diabetic patients with DSP |
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Inclusion Criteria:
Subjects must fulfil all of the following criteria to be appropriate to enter into Registry (Visit 2)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Qi Wan | Jiangsu Provincial People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiangsu Provincial People's Hospital | Nanjing | Jiangsu | 210029 | China |
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| ID | Term |
|---|---|
| D008063 | Thioctic Acid |
| ID | Term |
|---|---|
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
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| Placebo | Other | Tablet, placebo, 1-week single-blind placebo treatment then, 30 min before breakfast, once daily for 6 weeks |
|
| 6 weeks |
| To evaluate response rate of Thioctacid tablet 600mg once daily vs. placebo in 6-weeks' treatment in Chinese diabetic patients with DSP | 6 weeks |
| To evaluate the tolerability and safety of Thioctacid tablet 600mg once daily vs. placebo in 6-weeks' treatment in Chinese diabetic patients with DSP | Number of adverse events and standard laboratory tests will be the Measures of Safety and Tolerability | 6 weeks |
| Affiliated Hospital of Nantong University | Nantong | Jiangsu | 226001 | China |
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| The Second Affiliated Hospital of Soochow University | Suzhou | Jiangsu | 215004 | China |
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| The First Affiliated Hospital of Soochow University | Suzhou | Jiangsu | 215006 | China |
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| Wuxi No.2 People's Hospital | Wuxi | Jiangsu | 214002 | China |
|
| D003067 |
| Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D005227 | Fatty Acids |
| D008055 | Lipids |