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

NCT04955145 | Unknown Phase 3

• 1 other identifier: ACUC-Fb-ASU RHDIRB2020110301
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

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 Blood samples will be withdrawn for measurement of; MDA, TNF-α ,GSH-PX, C-RP levels and ESR.

Conditions

End Stage Renal Disease

Keywords

Oxidative stress, antioxidants, hemodialysis, vitamin C and Rutin

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (2)

• Quality of life of end stage renal disease patients on hemodialysis

  At baseline(pre-intervention)

• Quality of life of end stage renal disease patients on hemodialysis

  At end of the study(After the end of the intervention immediately)

Study Arms (3)

Ruta C 60 group

ACTIVE COMPARATOR

Ascorbic Acid/Rutoside 60 tablet , each tablet contains: Rutin 60mg and Ascorbic acid 160mg Dosage:2 tablets three times daily for 4 months

Drug: RUTA C 60

C- Retard group

ACTIVE COMPARATOR

Ascorbic acid 500mg capsule dosage: 1 capsule two times daily for 4 months

Drug: RUTA C 60

Control group

NO INTERVENTION

No intervention

Interventions

RUTA C 60 DRUG

Rutin known as vitamin p or rotoside and C-retard is Ascorbic acid

Also known as: C-retard

C- Retard group; Ruta C 60 group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age of patients \> 18 year old.
• hemodialysis in the last 3 months or longer.
• hemodialysis frequency 3 times per week or more.

You may not qualify if:

• Treatment with antioxidant agents \[such as vitamin C and E during the 2 preceding months prior to the study.
• Active liver disease
• pregnant patients or patients planning pregnancy.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain shams university hospitals

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Samia Mohamed Omar, Master student

  Faculty of pharmacy-Ain shams university

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Samia Mohamed Omar, Master student

CONTACT

(02)1011409183; samia.omar18@pharma.asu.edu.eg

Nagwa Ali Sabri, Professor

CONTACT

(02)1223411984; Nagwa.sabri@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 4, 2021
• First Posted: July 8, 2021
• Study Start: June 20, 2021
• Primary Completion: January 1, 2022
• Study Completion: February 1, 2022
• Last Updated: July 19, 2021

Record last verified: 2021-07

Locations

EG (1)