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Macular edema is the main cause of low vision in diabetics. They continue looking for new treatment alternatives. The nutritional supplement Alzer, is a powerful antioxidant that together with Diamel, a supplement that has shown efficacy in metabolic control, could be a therapeutic option. Objective: To evaluate the therapeutic efficacy of the Alzer Diamel combination in mild and moderate macular edema. Material and method: A randomized double-blind phase II clinical trial versus placebo will be conducted in 64 patients, who will be randomly assigned to two groups, one will receive Alzer + Diamel and another will receive placebo from Alzer and Diamel. All patients will undergo clinical, biochemical and ophthalmological evaluation during the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I | Experimental | 32 patients with mild or moderate diabetic macular edema. |
|
| Group II | Placebo Comparator | 32 patients with mild or moderate diabetic macular edema |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral treatment Alzer y Diamel | Dietary Supplement | Alzer: Administration way: Oral Dosage: one 500 mg tablet 3 times a day (1500 mg daily) Frequency: after breakfast, lunch and dinner. Duration: one year. Diamel: Administration way: Oral Dosage: two 660mg capsules 3 times a day (3960 mg daily) Frequency: before breakfast, lunch and dinner. Duration: one year. |
| Measure | Description | Time Frame |
|---|---|---|
| Macular retinal thickness | macular retinal measure | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Visual acuity | visual acuity test | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Juana Elvira Maciques RodrÃguez, Dr. | National Institute of Endocrinology, Cuba | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institute of Endocrinology | Vedado | La Habana | 10400 | Cuba |
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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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| Placebo | Dietary Supplement | Placebo treatment |
|