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| Name | Class |
|---|---|
| Gencor Pacific Limited, Hong Kong | INDUSTRY |
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The goal of this clinical trial is to assess the efficacy of Levagen+ supplementation for the symptoms of diabetic peripheral neuropathy (DPN) in patients with DPN.
Participants will have remote visits and attend a local pathology centre for blood draws. They will take the study product for 12 weeks, from baseline to week 12 they will have remote visits every 3 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Levagen+ | Experimental | Take 1 capsule twice daily with water after food. Each capsule will contain: A175mg containing 150 mg of palmitoylethanolamide (PEA). Total daily dose of 350mg Levagen+ containing 300 mg PEA. |
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| Placebo | Placebo Comparator | Take 1 capsule twice daily with water after food. Each capsule will contain microcrystalline cellulose [MCC]. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levagen+ | Dietary Supplement | Participants will take 1 capsule twice daily with water after food. Each capsule will contain: A175mg containing 150 mg of palmitoylethanolamide (PEA). Total daily dose of 350mg Levagen+ containing 300 mg PEA |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to the end of the study period in overall severity of neuropathic pain | Change from baseline to the end of the study period in overall severity of neuropathic pain, as assessed by the Brief Pain Inventory Short Form for Diabetic Peripheral Neuropathy (BPI-DPN). This is a self-reported scale, higher scores indicate greater pain and interference. | Baseline to week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to the end of the study period in Neuropathic Pain Symptom Inventory | Change from baseline to the end of the study period in Neuropathic Pain Symptom Inventory (NPSI). This is a self-administered questionnaire used to evaluate neuropathic pain intensity across 5 categories, namely "superficial spontaneous pain", "deep spontaneous pain", "paroxysmal pain", "evoked pain", and "dysesthesia / paraesthesia". There are 10 pain descriptors and 2 items related to abnormal sensations. The scale ranges from 0 (no pain at all) to 10 (worst pain imaginable). The total scores of all items are combined to find the total pain intensity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amanda Rao | Contact | +61(0)731024486 | research@rdcglobal.com.au |
| Name | Affiliation | Role |
|---|---|---|
| Ramasamy Venkatesh | Gencor Pacific | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RDC Clinical | Recruiting | Fortitude Valley | Queensland | 4006 | Australia |
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| ID | Term |
|---|---|
| C005958 | palmidrol |
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Randomized, single-blind, placebo-controlled, parallel dose response study
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| Placebo | Other | Participants will take 1 capsule twice daily with water after food. Each capsule will contain microcrystalline cellulose [MCC] |
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| Baseline to week 12 |
| Change from baseline to the end of the study period in Safety via Adverse Event reporting | Change from baseline to the end of the study period in safety via Adverse Event reporting and incident rate ratio between placebo and Levagen+ | Baseline to week 12 |
| Change from baseline to the end of the study period in Safety Markers (FBC) | Change from baseline to the end of the study period in safety Markers (FBC - Full Blood Count) via blood test. | Baseline to week 12 |
| Change from baseline to the end of the study period in Safety Markers (E/LFT) | Change from baseline to the end of the study period in safety Markers (E/LFT) via blood test. | Baseline to week 12 |
| Change from baseline to the end of the study period in Safety (Vitals - BP) | Change from baseline to the end of the study period in Safety Markers vital signs (blood pressure) | Baseline to week 12 |
| Change from baseline to the end of the study period in Safety (Vitals - heart rate) | Change from baseline to the end of the study period in Safety Markers vital signs (heart rate) | Baseline to week 12 |
| Change from baseline to the end of the study period in Medical Outcomes Study - Sleep Scale (MOS-Sleep) | Change from baseline to the end of the study period in Medical Outcomes Study - Sleep Scale (MOS-Sleep). This is a self-administered 12-item questionnaire that includes a Sleep Problem Index and evaluates 6 dimensions of sleep difficulty, namely: "sleep disturbance", "sleep adequacy", somnolence", "quantity of sleep/optimal sleep", "awakening short of breath or with headache", and "occurrence of snoring". The Sleep Problem Index summarises information across 9 items and is rated on a scale of 1 (all of the time) to 6 (none of the time). | Baseline to week 12 |
| Change from baseline to the end of the study period in Depression Anxiety and Stress Scale (DASS-21) | Change from baseline to the end of the study period in Depression Anxiety and Stress Scale (DASS-21). The DASS-21 is a self-reported questionnaire derived from the original 42-item DASS and is a quantitative measure of distress. It consists of 3 subscales: the depression subscale (DASS-D), anxiety subscale (DASS-A) and stress subscale (DASS-S). Each subscale contains 7 items which are rated on a 4-point severity/frequency scale. The scores for each subscale are calculated by summing the scores for the relevant items. Higher scores indicate greater distress. | Baseline to week 12 |
| Change from baseline to the end of the study period in Glycaemic control (HbA1c) | Change from baseline to the end of the study period in Glycaemic control (HbA1c) | Baseline to week 12 |
| Change from baseline to the end of the study period in Glycaemic control (fasting blood glucose) | Change from baseline to the end of the study period in Glycaemic control (fasting blood glucose) | Baseline to week 12 |
| Change from baseline to the end of the study period in Anthropometry (weight) | Change from baseline to the end of the study period in Anthropometry (weight). | Baseline to week 12 |
| Change from baseline to the end of the study period in Anthropometry (height) | Change from baseline to the end of the study period in Anthropometry (height). | Baseline to week 12 |
| Change from baseline to the end of the study period in Anthropometry (BMI) | Change from baseline to the end of the study period in Anthropometry (BMI). | Baseline to week 12 |
| Change from baseline to the end of the study period in use of rescue medication for pain | Change from baseline to the end of the study period in use of rescue medication for pain. Participants will be allowed to use a rescue medication as needed, with use documented via participant diaries including date, time, dosage, reason for use. Data will be analysed based on total usage, frequency, and the proportion of participants requiring rescue medication. | Baseline to week 12 |