Hemodialysis PatientsNCT06314243
The Impact of Pumpkin Seed Oil Supplementation on Hemodialysis Patients
A study testing Pumpkin Seed Oil " Ronkin®, KMT PHARMA, Egypt. " in people with Hemodialysis Patients, run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodialysis Patients
- What is being tested?
- Pumpkin Seed Oil " Ronkin®, KMT PHARMA, Egypt. "
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteEgypt
- Study dates
- 4 Sep 2024to 10 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients older than 18.
- Patients undergoing regular HD for at least 3 months prior to enrollment.
- Not participate in any other clinical trials.
- Physically stable.
Who cannot join
- Patients taking antioxidant supplements prior to the study's two-month time frame.
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Adult Nephrology and Dialysis Unit, Ain Shams University Hospital, Cairo, Egypt.
Cairo, 11766
About this study
Official title: The Impact of Pumpkin Seed Oil Supplementation on the Clinical Outcome in Hemodialysis Patients
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 don't to see if PSO supplementation improves their systemic inflammation, oxidative stress, and lipid profile.
Read the 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.
- Conditions
- Hemodialysis Patients
- Being tested
- Pumpkin Seed Oil " Ronkin®, KMT PHARMA, Egypt. "
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pumpkin Seed Oil " Ronkin®, KMT PHARMA, Egypt. "Dietary supplement
Also called Pepon
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%)
| Study group | Role | What they receive |
|---|---|---|
| Pumpkin Seed Oil group | Experimental | 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. " Receives: Dietary Supplement: Pumpkin Seed Oil " Ronkin®, KMT PHARMA, Egypt. " |
| Control group | No intervention | Group 2 (Control group): consists of 28 patients who will not receive the intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the effect of PSO supplementation on oxidative stress in hemodialysis patients.
To evaluate the effect of PSO supplementation on oxidative stress via measuring malondialdehyde (MDA) as oxidative stress marker.
Measured: 12 weeks
To evaluate the effect of PSO supplementation on the systemic inflammation in hemodialysis patients.
To evaluate the effect of PSO supplementation on the systemic inflammation via measuring interleukin-6 (IL-6) as inflammatory marker.
Measured: 12 weeks
Secondary outcomes (1)
To evaluate the effect of PSO supplementation on the lipid profile in hemodialysis patients.
To evaluate the effect of PSO supplementation on the lipid profile, include triglyceride (TG), total cholesterol (TC), LDL, and HDL measurements.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start4 Sep 2024
- Primary completion31 Dec 2024
- Study completion10 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodialysis PatientsStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merna Nasry, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06314243
- Sponsor's protocol ID
- RHDIRB2020110301 REC #241
- Status last verified
- Jul 2024
- First submitted
- 11 Mar 2024
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Pumpkin Seed Oil Supplementation on the Clinical Outcome in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT06314243
- Acronym / sponsor ID
- RHDIRB2020110301 REC #241
- Conditions
- Hemodialysis Patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 4 Sep 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 10 Jul 2025 (actual)
- First posted
- 18 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 don't 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Pumpkin Seed Oil group | Experimental | Dietary Supplement: Pumpkin Seed Oil " Ronkin®, KMT PHARMA, Egypt. "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. " |
| Control group | No intervention | –Group 2 (Control group): consists of 28 patients who will not receive the intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female patients older than 18.
- Patients undergoing regular HD for at least 3 months prior to enrollment.
- Not participate in any other clinical trials.
- Physically stable.
Key exclusion criteria (7 listed)
- Patients taking antioxidant supplements prior to the study's two-month time frame.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pumpkin Seed Oil " Ronkin®, KMT PHARMA, Egypt. "Also: PeponRonkin 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%) | Dietary supplement | Pumpkin Seed Oil group |
Primary outcome
To evaluate the effect of PSO supplementation on oxidative stress in hemodialysis patients.
Time frame: 12 weeks
To evaluate the effect of PSO supplementation on oxidative stress via measuring malondialdehyde (MDA) as oxidative stress marker.
To evaluate the effect of PSO supplementation on the systemic inflammation in hemodialysis patients.
Time frame: 12 weeks
To evaluate the effect of PSO supplementation on the systemic inflammation via measuring interleukin-6 (IL-6) as inflammatory marker.
1 secondary outcome
To evaluate the effect of PSO supplementation on the lipid profile in hemodialysis patients.
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pumpkin Seed Oil " Ronkin®, KMT PHARMA, Egypt. " in people with Hemodialysis Patients, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the effect of PSO supplementation on oxidative stress in hemodialysis patients. (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.