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Rutin and Vitamin C for Oxidative Stress in Hemodialysis
NCT04955145Phase 3
Key facts
- Status
- Unknown
- Start
- Jun 2021
- Primary completion
- Jan 2022
- Countries
- 1
- Sponsor
- Ain Shams University
- Modality
- Covalent Small Molecules, Classical Binding Small Molecules, Nucleic Acid-Directed Small Molecules
- Drugs
- rutin
- Conditions
- end stage renal disease (ESRD)
01
Overview
Phase 3, randomised, open-label trial of rutin in end stage renal disease (ESRD) (3 arms), sponsored by Ain Shams University. Primary endpoints: Malondialdehyde at 4 months, Glutathione Peroxidase at 4 months and 3 more. Status: unknown.
02
Design
3 arms- Study design
- RandomizedOpen-label
Ruta C 60
Rutin 60mg + Vitamin C 160mg (2 tablets, 3 times daily)
Vitamin C
Vitamin C 500mg (1 capsule, 2 times daily)
Control
Standard therapy only
03
Who it enrols
Adult patients with ESRD on regular hemodialysis for at least 3 months. Excludes patients who took antioxidants in the prior 2 months, have active liver disease, or are pregnant.
04
Endpoints
Primary
Malondialdehyde
Glutathione Peroxidase
Tumor Necrosis Factor-alpha
C-Reactive Protein
Erythrocyte Sedimentation Rate
Secondary
Quality of Life
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