Effect and safety of the use of Viusid® on the quality of life of patients with Chronic Kidney Disease on Hemodialysis.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

RPCEC

Registry ID

RPCEC00000420

Enrollment

Registered

2023-03-27

Start date

2023-04-05

Completion date

Unknown

Last updated

2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease

Interventions

Experimental group: Viusid (1 vial, 30 mL), once a day, orally in single doses, for 6 months. The patients function as their own historical control.

Dietary Supplements

Administration, Oral

Viusid

Eligibility

Sex/Gender

All

Age

19 Years to No maximum

Inclusion criteria

Inclusion criteria: 1-Patients who meet the diagnostic criteria. 2-Patients who give their consent 3-Patients 19 years or older 4-Patients with 3 months or more on hemodialysis.

Exclusion criteria

Exclusion criteria: 1-Patients with active infection at the time of inclusion. 2-Pregnant or lactating patients. 3-Patients with a diagnosis of active immunological disease or mental disability. 4-Patients who are under treatment with chemotherapy or radiotherapy. 5-Patients with known hypersensitivity to products similar to Viusid® oral solution. 6-Patients who are receiving another investigational product.

Design outcomes

Primary

Measure	Time frame
Quality of life (QOL Questionnaire (SF-36). Measurement time: at the beginning and at month 6.	—

Secondary

Measure	Time frame
1-Presence and severity of symptoms and signs (palliative care symptom scale, POS-S Renal). Measurement time: at baseline and at month 6. 2-Nutritional status (hematological and biochemical parameters: a-hemoglobin, b-hematocrit, c-total leukocyte count, d-lymphocytes, e-prealbumin, f-albumin, g-total protein, h-cholesterol, i-creatinine, urea). Measurement time: at the beginning and at month 6. 3-Dynamic parameters (weight variation (pounds and/or kg) and BMI (kg/m2). Measurement time: at the beginning, month 3 and months 6. 4-Parameters of the inflammatory state (a-Hemogram indices (of 5 parts), b-Prealbumin, c-Albumin, d-C-reactive protein, e-Transferrin, f-Erythropoietin resistance index, g-Neutrophil/lymphocyte index, Platelet/lymphocyte index). Measurement time: beginning, month 3 and month 6. 5-Safety (AE of the study: intensity, severity, causality, attitude towards treatment and result. Questioning, physical examination and batch of the PI. Measurement time Month 3 and month 6.	—

Measure

Time frame

1-Presence and severity of symptoms and signs (palliative care symptom scale, POS-S Renal). Measurement time: at baseline and at month 6. 2-Nutritional status (hematological and biochemical parameters: a-hemoglobin, b-hematocrit, c-total leukocyte count, d-lymphocytes, e-prealbumin, f-albumin, g-total protein, h-cholesterol, i-creatinine, urea). Measurement time: at the beginning and at month 6. 3-Dynamic parameters (weight variation (pounds and/or kg) and BMI (kg/m2). Measurement time: at the beginning, month 3 and months 6. 4-Parameters of the inflammatory state (a-Hemogram indices (of 5 parts), b-Prealbumin, c-Albumin, d-C-reactive protein, e-Transferrin, f-Erythropoietin resistance index, g-Neutrophil/lymphocyte index, Platelet/lymphocyte index). Measurement time: beginning, month 3 and month 6. 5-Safety (AE of the study: intensity, severity, causality, attitude towards treatment and result. Questioning, physical examination and batch of the PI. Measurement time Month 3 and month 6.

—

Countries

Cuba

Contacts

Public ContactIvis Mendoza Hernandez

National Coordinating Clinical Trials Center (CENCEC)

ivis@cencec.sld.cu

Outcome results

None listed

Source: RPCEC (via WHO ICTRP) · Data processed: Aug 25, 2026