Effect of Diosmin/Hesperidin Combination on Platinum Comp... | NCT07598214

Studies
Effect of Diosmin/Hesperidin Combination on Platinum Compounds-Induced Nephropathy in Cancer Patients

NCT07598214

Sponsor

Beni-Suef University

Status

Recruiting

Last Update Posted

May 20, 2026Actual

Enrollment

100Estimated

Phase

Phase 4

Conditions

Cancer Patients

Interventions

diosmin/hesperdin

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
FWA00015574	Other Identifier	FWA #

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 3, 2025Actual

Primary Completion Date

Nov 3, 2026Estimated

Completion Date

Dec 3, 2026Estimated

First Submitted Date

Feb 1, 2026

First Submission Date that Met QC Criteria

May 17, 2026

First Posted Date

May 20, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 17, 2026

Last Update Posted Date

May 20, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
control	Experimental	patients will take no intervention	Combination Product: diosmin/hesperdin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
diosmin/hesperdin	Combination Product	combination of Diosmin and Hesperidin	control

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
marwa mohsen, PhD	Contact	01202203223		marwa.mohsen@pharm.bsu.edu.eg

Overall Officials

Name	Affiliation	Role
marwa mohsen	clinical pharmacy department, Beni Suef University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Medicine	Recruiting	Banī Suwayf		0000	Egypt

Intervention Browse Module

MeSH Terms

ID	Term
D004145	Diosmin

Ancestor Terms

ID	Term
D047309	Flavones
D005419	Flavonoids
D002867	Chromones
D001578	Benzopyrans
D011714

Browse Leaves

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Browse Branches

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