Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06314243
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-14
First Post:
2024-03-11
Brief Title:
The Impact of Pumpkin Seed Oil Supplementation on Hemodialysis Patients
Sponsor:
Ain Shams University
Organization:
Ain Shams University
Study Overview
Official Title:
The Impact of Pumpkin Seed Oil Supplementation on the Clinical Outcome in Hemodialysis Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to investigate the effects of Pumpkin Seed Oil PSO supplementation on systemic inflammation oxidative stress and lipid profile in hemodialysis patients
The main question it aims to answer is
Does PSO have a promising effect on systemic inflammation oxidative stress and lipid profile in hemodialysis patients
Patients on regular hemodialysis who take PSO supplementation will be compared to those who dont to see if PSO supplementation improves their systemic inflammation oxidative stress and lipid profile
The main question it aims to answer is
Does PSO have a promising effect on systemic inflammation oxidative stress and lipid profile in hemodialysis patients
Patients on regular hemodialysis who take PSO supplementation will be compared to those who dont to see if PSO supplementation improves their systemic inflammation oxidative stress and lipid profile
Detailed Description:
This study aims to investigate the effects of PSO supplementation on systemic inflammation oxidative stress and lipid profile in hemodialysis patients via assessment of IL-6 MDA lipid profile and kidney function tests
Patients Methods
Design Prospective randomized Open label - controlled clinical trial
Patients A total of 56 patients on regular hemodialysis HD will be enrolled in the study These patients will be randomly allocated into two equal groups
Group 1 PSO group consists of 28 patients who will receive one capsule containing 1010 mg PSO once daily for 12 weeks Ronkin KMT PHARMA Egypt
Group 2 Control group consists of 28 patients who will not receive the intervention
Setting Adult Nephrology and Dialysis Unit Ain Shams University Hospital Cairo Egypt
Blood samples will be taken in the dialysis unit and will be sent to Ain Shams University labs for analysis
Patients Methods
Design Prospective randomized Open label - controlled clinical trial
Patients A total of 56 patients on regular hemodialysis HD will be enrolled in the study These patients will be randomly allocated into two equal groups
Group 1 PSO group consists of 28 patients who will receive one capsule containing 1010 mg PSO once daily for 12 weeks Ronkin KMT PHARMA Egypt
Group 2 Control group consists of 28 patients who will not receive the intervention
Setting Adult Nephrology and Dialysis Unit Ain Shams University Hospital Cairo Egypt
Blood samples will be taken in the dialysis unit and will be sent to Ain Shams University labs for analysis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None