Cancer PatientsPhase 4Dios/Hes-PTNCT07598214
Effect of Diosmin/Hesperidin Combination on Platinum Compounds-Induced Nephropathy in Cancer Patients
A Phase 4 study testing diosmin/hesperdin in people with Cancer Patients, run by Beni-Suef University at 1 site in Egypt.
Trial summary
The current study aims to investigate the protective properties of diosmin/hesperidin on cisplatin-induced nephrotoxicity. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cancer Patients
- What is being tested?
- diosmin/hesperdin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Feb 2025to 3 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of 18 to 75 year-age must have histologically or cytologically confirmed cancer by the Laboratory of Pathology receiving a platinum compound chemotherapy.
Who cannot join
- -History of allergic reactions attributed to drugs in the study.
- Pregnant women.
- Life expectancy less than 6 months
- Inability or unwillingness to comply with research protocols.
- Cancer patients with impaired renal function (creatinine clearance < 50 mL/min)
- Preexisting hearing loss.
- Patients taking nephrotoxic drugs; and those who have a history of allergic reactions to platinum-containing compounds.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine
Banī Suwayf, 0000
beni suef university
About this study
Official title: Evaluation of the Effect of Diosmin/Hesperidin Combination on Platinum Compounds-Induced Nephropathy in Cancer Patients: A Randomized Controlled Trial
The current study aims to investigate the protective properties of diosmin/hesperidin on cisplatin-induced nephrotoxicity.
Read the detailed description
The current study is a prospective randomized controlled clinical study that will be conducted on about 100 cancer patients.
Study duration The study will be conducted from January 2025 to September 2025
Study population Group I (control): includes 37 cancer patients administrating platinum compounds in their chemotherapeutic cycles as standard therapy.
Group II (Test group) includes 37 cancer patients administrating platinum compounds in their chemotherapeutic cycles as standard therapy plus 450 mg diosmin and 50 mg hesperidin combination orally twice daily.
- Conditions
- Cancer Patients
- Being tested
- diosmin/hesperdin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diosmin/hesperdinCombination product
combination of Diosmin and Hesperidin
| Study group | Role | What they receive |
|---|---|---|
| control | Experimental | patients will take no intervention Receives: Combination Product: diosmin/hesperdin |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum creatinine level
Serum creatinine will be measured in mg/dl every 2 weeks during the study period.
Measured: 6 months following treatment
blood urea level
blood urea levels will be measured in mg/dl every 2 weeks during the study period.
Measured: 6 months following treatment
Secondary outcomes (1)
hemoglobin level
Hemoglobin levels will be measured in g/dl every 2 weeks during the study period.
Measured: 6 months following treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study start3 Feb 2025
- Primary completion3 Nov 2026 (estimated)
- Study completion3 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer PatientsStudies of the same condition, open and under way.
- More trials run by Beni-Suef 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hasnaa Osama, Beni-Suef University
- Investigators
- marwa mohsen, Principal investigator, clinical pharmacy department, Beni Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07598214
- Sponsor's protocol ID
- FMBSUREC/03122024/Mahmoud
- Other IDs
- FWA00015574
- Acronym
- Dios/Hes-PT
- Status last verified
- May 2026
- First submitted
- 1 Feb 2026
- Last updated
- 20 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Diosmin/Hesperidin Combination on Platinum Compounds-Induced Nephropathy in Cancer Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07598214
- Acronym / sponsor ID
- Dios/Hes-PT / FMBSUREC/03122024/Mahmoud
- Conditions
- Cancer Patients
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 3 Feb 2025 (actual)
- Primary completion
- 3 Nov 2026 (estimated)
- Study completion
- 3 Dec 2026 (estimated)
- First posted
- 20 May 2026 (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 current study aims to investigate the protective properties of diosmin/hesperidin on cisplatin-induced nephrotoxicity.
Detailed description
The current study is a prospective randomized controlled clinical study that will be conducted on about 100 cancer patients.
Study duration The study will be conducted from January 2025 to September 2025
Study population Group I (control): includes 37 cancer patients administrating platinum compounds in their chemotherapeutic cycles as standard therapy.
Group II (Test group) includes 37 cancer patients administrating platinum compounds in their chemotherapeutic cycles as standard therapy plus 450 mg diosmin and 50 mg hesperidin combination orally twice daily.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| control | Experimental | Combination Product: diosmin/hesperdinpatients will take no intervention |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients of 18 to 75 year-age must have histologically or cytologically confirmed cancer by the Laboratory of Pathology receiving a platinum compound chemotherapy.
Key exclusion criteria (7 listed)
- -History of allergic reactions attributed to drugs in the study.
- Pregnant women.
- Life expectancy less than 6 months
- Inability or unwillingness to comply with research protocols.
- Cancer patients with impaired renal function (creatinine clearance < 50 mL/min)
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 |
|---|---|---|
| diosmin/hesperdincombination of Diosmin and Hesperidin | Combination product | control |
Primary outcome
serum creatinine level
Time frame: 6 months following treatment
Serum creatinine will be measured in mg/dl every 2 weeks during the study period.
blood urea level
Time frame: 6 months following treatment
blood urea levels will be measured in mg/dl every 2 weeks during the study period.
1 secondary outcome
hemoglobin level
Time frame: 6 months following treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 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.
marwa mohsen principal investigator
clinical pharmacy department, Beni Suef University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing diosmin/hesperdin in people with Cancer Patients, run by Beni-Suef 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 1 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: looking for participants now, as of the sponsor's last update on 20 May 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact marwa mohsen, PhD (01202203223, marwa.mohsen@pharm.bsu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum creatinine level (time frame: 6 months following treatment). 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 20 May 2026.