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Decision of the investigator
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The purpose of the study is to determine whether Viusid administration improves malnutrition, atherosclerosis, erythropoietin response and the frequency of infection episodes in subjects with Chronic Inflammatory Syndrome under hemodialysis treatment. The duration of this double-blind placebo controlled phase 3 clinical trial will be 60 weeks. All patients enrolled in the study will be receiving the standard treatment for Chronic Inflammatory Syndrome including hemodialysis and administration of a hypercaloric and hyperproteic diet. Efficacy assessment will be carried out 12 weeks after the end of Viusid or placebo treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Viusid in combination with standard treatment for Chronic Inflammatory Syndrome including hemodialysis and the administration of a hypercaloric and hyperproteic diet |
|
| B | Placebo Comparator | Placebo in combination with standard treatment for Chronic Inflammatory Syndrome including hemodialysis and the administration of a hypercaloric and hyperproteic diet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Viusid | Dietary Supplement | 3 Viusid bags (Orally administered) per day, for 60 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Body mass index (BMI) at week 72 (end of the treatment) | 72 weeks | |
| Carotidal Doppler at week 72 (end of the treatment) | 72 weeks | |
| C reactive protein at weeks 72 (end of the treatment) | 72 weeks | |
| Hemoglobin at week 72 (end of the treatment) | 72 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Cholesterol at week 72 | 72 weeks | |
| Triglycerides at week 72 | 72 weeks | |
| Frequency of infection episodes at week 72 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mirna Atiés Sánchez, MD | Institute of Nephrology "Dr. Abelardo Buch López" | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Nephrology "Dr. Abelardo Buch López" | Havana | 10400 | Cuba |
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| ID | Term |
|---|---|
| C551853 | Viusid |
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| Placebo |
| Dietary Supplement |
3 Placebo bags (Orally administered) per day, for 60 weeks. |
|
| 72 weeks |
| Creatinine at week 72 | 72 weeks |
| Uric acid at week 72 | 72 weeks |
| Glutamic-pyruvic transaminase (GPT)at week 72 | 72 weeks |
| Glutamic-oxaloacetic transaminase (GOT)at week 72 | 72 weeks |
| Blood glucose concentrations at week 72 | 72 weeks |
| Gasometry at week 72 | 72 weeks |
| Adverse effects at week 72 | 72 weeks |
| Albumin at week 72 | 72 weeks |
| KTV at week 72 | 72 weeks |
| Phosphocalcic metabolism at week 72 | 72 weeks |
| Hematocrit at week 72 | 72 weeks |