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Clinical Trial Details

Trial ID: L0780
Source ID: NCT04955145
Associated Drug: Ruta C 60
Title: Evaluation of The Effect of Rutin and Vitamin C on the Oxidative Stress in Hemodialysis Patients
Acronym:
Status: UNKNOWN
Study Results: NO
Results:
Conditions: End Stage Renal Disease
Interventions: DRUG: RUTA C 60
Outcome Measures: Primary: The change in Malondialdehyde(MDA) level from the baseline will be assessed at the end of the study (after the end of the intervention), Micromole/L, At baseline(pre-intervention)|The change of Malondialdehyde(MDA) level from the baseline(Pre-intervention) will be assessed at the end of the study (after the end of the intervention), Micromole/L, At end of the study (After the end of the intervention immediately)|The change of Glutathione peroxidase(GSH-PX) level from the baseline will be assessed at end of the study(After end of the intervention), Micromole/L, At baseline(pre-intervention)|The change of Glutathione peroxidase(GSH-PX) level from the baseline(pre-intervention) will be assessed at end of the study(After end of the intervention immediately), Micromole/L, At end of the study (After the end of the intervention immediately)|The change of Tumor necrosis factor-alpha(TNF-alpha) level from the baseline will be assessed at the end of the study (after the end of the intervention immediately), pg/ml, At baseline(pre-intervention)|The change of Tumor necrosis factor-alpha(TNF-alpha) level from the baseline will be assessed at the end of the study, pg/ml, At end of the study(After the end of the intervention immediately)|The change of C-Reactive protein(C-RP) level from the baseline will be assessed at the end of the study, mg/L, At baseline(pre-intervention)|The change of C-Reactive protein(C-RP) level from the baseline will be assessed at the end of the study, mg/L, At end of the study(After the end of the intervention immediately)|The change in Erythrocyte sedimentation rate from the baseline will be assessed at the end of the study Erythrocyte sedimentation rate (ESR), mm/hour, At baseline(pre-intervention)|The change in Erythrocyte sedimentation rate from the baseline will be assessed at the end of the study, mm/hour, At end of the study(After the end of the intervention immediately) | Secondary: Quality of life of end stage renal disease patients on hemodialysis, The Kidney Disease Quality of Life short form questionnaire 36 Physical function Physical role Pain General health Physical component summary Emotional well-being Emotional role Social function Energy/fatigue Mental component summary Symptoms and problems Effects of kidney disease Burden of kidney disease Work status Cognitive function Quality of social interaction Sexual function Sleep Social support Dialysis staff encouragement Patient satisfaction Kidney disease component summary SF, short form. For each domain and, summary measure, the score ranges from 0 to 100, with a higher score indicating better quality of life., At baseline(pre-intervention)|Quality of life of end stage renal disease patients on hemodialysis, The Kidney Disease Quality of Life short form questionnaire 36 Physical function Physical role Pain General health Physical component summary Emotional well-being Emotional role Social function Energy/fatigue Mental component summary Symptoms and problems Effects of kidney disease Burden of kidney disease Work status Cognitive function Quality of social interaction Sexual function Sleep Social support Dialysis staff encouragement Patient satisfaction Kidney disease component summary SF, short form. For each domain and, summary measure, the score ranges from 0 to 100, with a higher score indicating better quality of life., At end of the study(After the end of the intervention immediately)
Sponsor/Collaborators: Sponsor: Ain Shams University
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 105
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2021-06-20
Completion Date: 2022-02
Results First Posted:
Last Update Posted: 2021-07-19
Locations: Ain shams university hospitals, Cairo, Egypt
URL: https://clinicaltrials.gov/show/NCT04955145