The Impact of Pumpkin Seed Oil Supplementation on Hemodialysis Patients
NCT ID: NCT06314243
Last Updated: 2025-08-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
46 participants
INTERVENTIONAL
2024-09-04
2025-07-10
Brief Summary
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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 don't to see if PSO supplementation improves their systemic inflammation, oxidative stress, and lipid profile.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
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.
TREATMENT
NONE
Study Groups
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Pumpkin Seed Oil group
Group 1 (Pumpkin Seed Oil group): consists of 28 patients who will receive one capsule containing 1010 mg PSO once daily for 12 weeks, " Ronkin®, KMT PHARMA, Egypt. "
Pumpkin Seed Oil " Ronkin®, KMT PHARMA, Egypt. "
Ronkin soft gelatin capsules, each containing 1010 mg of pumpkin seed oil (Latin name: Curcurbita pepo), standardized to contain palmitic acid (8-15%), stearic acid (3-8%), oleic acid (15-35%), linoleic acid (40-65%), and other fatty acids (≤ 2.4%)
Control group
Group 2 (Control group): consists of 28 patients who will not receive the intervention.
No interventions assigned to this group
Interventions
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Pumpkin Seed Oil " Ronkin®, KMT PHARMA, Egypt. "
Ronkin soft gelatin capsules, each containing 1010 mg of pumpkin seed oil (Latin name: Curcurbita pepo), standardized to contain palmitic acid (8-15%), stearic acid (3-8%), oleic acid (15-35%), linoleic acid (40-65%), and other fatty acids (≤ 2.4%)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients undergoing regular HD for at least 3 months prior to enrollment.
* Not participate in any other clinical trials.
* Physically stable.
Exclusion Criteria
* Patients with autoimmune, liver, cancer diseases and acquired immunodeficiency syndrome (AIDS).
* Sensitivity to pumpkin seed oil.
* Patients taking warfarin.
* History of drug or alcohol abuse.
* Pregnant or breastfeeding women and women with the possibility of getting pregnant.
* Smokers.
18 Years
ALL
No
Sponsors
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Ain Shams University
OTHER
Responsible Party
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Merna Nasry
Demonstrator of Clinical Pharmacy Department, Faculty of pharmacy, Ain Shams University
Locations
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Adult Nephrology and Dialysis Unit, Ain Shams University Hospital, Cairo, Egypt.
Cairo, , Egypt
Countries
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Other Identifiers
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RHDIRB2020110301 REC #241
Identifier Type: -
Identifier Source: org_study_id
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