Effect of Diosmin/Hesperidin Combination on Platinum Compounds-Induced Nephropathy in Cancer Patients (Dios/Hes-PT)

May 17, 2026 updated by: Hasnaa Osama, Beni-Suef University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Banī Suwayf, Egypt, 0000
        • Recruiting
        • Faculty of medicine
        • Contact:
          • beni suef university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients of 18 to 75 year-age must have histologically or cytologically confirmed cancer by the Laboratory of Pathology receiving a platinum compound chemotherapy.

Exclusion Criteria:

  • -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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: control
patients will take no intervention
Combination product: diosmin/hesperdin
combination of Diosmin and Hesperidin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
serum creatinine level
Time Frame: 6 months following treatment
Serum creatinine will be measured in mg/dl every 2 weeks during the study period.
6 months following treatment
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.
6 months following treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hemoglobin level
Time Frame: 6 months following treatment
Hemoglobin levels will be measured in g/dl every 2 weeks during the study period.
6 months following treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beni-Suef University

Investigators

  • Principal Investigator: marwa mohsen, clinical pharmacy department, Beni Suef University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 3, 2025

Primary Completion (Estimated)

November 3, 2026

Study Completion (Estimated)

December 3, 2026

Study Registration Dates

First Submitted

February 1, 2026

First Submitted That Met QC Criteria

May 17, 2026

First Posted (Actual)

May 20, 2026

Study Record Updates

Last Update Posted (Actual)

May 20, 2026

Last Update Submitted That Met QC Criteria

May 17, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMBSUREC/03122024/Mahmoud
  • FWA00015574 (Other Identifier: FWA #)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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