NCT04955145

Evaluation of The Effect of Rutin and Vitamin C on the Oxidative Stress in Hemodialysis Patients

Status unknown Phase 3 Last updated 15 July 2021

What this trial tests

Phase 3 trial testing RUTA C 60 in End Stage Renal Disease in 105 participants. Status unknown.

Timeline

20 June 2021

Primary endpoint
1 January 2022

1 February 2022

Quick facts

Lead sponsor	Ain Shams University
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	105
Start date	20 June 2021
Primary completion	1 January 2022
Estimated completion	1 February 2022
Sites	1 location across Egypt

Drugs / interventions tested

• RUTA C 60 — full drug profile →

Conditions studied

• End Stage Renal Disease — all drugs for End Stage Renal Disease →

Sponsor

Ain Shams University

Who can join

Adults 18 to 70, any sex, with End Stage Renal Disease. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• The change in Malondialdehyde(MDA) level from the baseline will be assessed at the end of the study (after the end of the intervention)
  Time frame: At baseline(pre-intervention)
  Micromole/L
• 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)
  Time frame: At end of the study (After the end of the intervention immediately)
  Micromole/L
• The change of Glutathione peroxidase(GSH-PX) level from the baseline will be assessed at end of the study(After end of the intervention)
  Time frame: At baseline(pre-intervention)
  Micromole/L
• 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)
  Time frame: At end of the study (After the end of the intervention immediately)
  Micromole/L
• 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)
  Time frame: At baseline(pre-intervention)
  pg/ml
• The change of Tumor necrosis factor-alpha(TNF-alpha) level from the baseline will be assessed at the end of the study
  Time frame: At end of the study(After the end of the intervention immediately)
  pg/ml

Sponsor's own description

The aim of the study is to evaluate the effect of rutin and vitamin C on selected oxidative stress and inflammatory markrers.

Patients will be recruited according to the inclusion and exclusion criteria and will be divided into 3 groups, Group 1: Patients will administer a combination of Vitamin C and Rutin (RUTA C 60 tablets) in a dose of 2 tablets 3 times daily for 4 months in addition to their standard therapy, Group 2: will administer vitamin C 500mg hard gelatin capsules (twice daily) in addition to their standard therapy for a period of 4 months, Group3 (Control group) will administer the standard therapy. Blood samples will be withdrawn for measurement of; MDA, TNF-α ,GSH-PX, C-RP levels and ESR.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Mitochondrial Oxidative Stress and Cell Death in Podocytopathies.
   Zhu YT, Wan C, Lin JH, Hammes HP, et al · · 2022 · cited 31× · PMID 35327595 · DOI 10.3390/biom12030403
2. Evaluation of the combination effect of rutin and vitamin C supplementation on the oxidative stress and inflammation in hemodialysis patients.
   Omar S, El Borolossy RM, Elsaid T, Sabri NA. · · 2022 · cited 15× · PMID 36160426 · DOI 10.3389/fphar.2022.961590
3. Acetylation in renal physiology and pathophysiology.
   Zhang JY, Wu J, Chen ZH, Liu SY, et al · · 2025 · cited 1× · PMID 41104330 · DOI 10.3389/fphar.2025.1660109