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this study is to be carried out to examine the effect of Investigation product on diabetic individuals suffering from diabetic neuropathic pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neuropaway | Active Comparator |
| |
| Microcystalline cellulose | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NeuropAWAY | Other | 2 capsules thrice daily to be taken half an hour prior to meal. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| effect of investigational product on diabetic individual suffering from diabetic neuropathy assessed by 11 point numeric rating scale. | pain intensity will be assessed by 11 point numeric rating scale where 0 indicates no pain and 10 indicates worst possible pain | 42 days |
| Measure | Description | Time Frame |
|---|---|---|
| effect of investigational product on diabetic individual suffering from diabetic neuropathy assessed by Brief pain inventory. | 42 days | |
| effect of investigational product on diabetic individual suffering from diabetic neuropathy assessed by insomnia Severity index. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stress Test Clinic | Mumbai | Maharashtra | 400047 | India | ||
| Shantaee |
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| Microcystalline cellulose |
| Other |
2 capsules thrice daily to be taken half an hour prior to meal. |
|
| 42 Days |
| effect of investigational product on diabetic individual suffering from diabetic neuropathy assessed by Neuropathy total symptom score - 6 . | 42 Days |
| Mumbai |
| Maharashtra |
| 400067 |
| India |
| ID | Term |
|---|---|
| D003929 | Diabetic Neuropathies |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
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