Hesperidin and Diosmin Effect on Metabolic Syndrome

February 14, 2022 updated by: Hasnaa Osama, Beni-Suef University

Hesperidin-Diosmin Effect on Metabolic Syndrome and Diabetic Neuropathy Among Patients With Type 2 Diabetes Mellitus

The components of metabolic syndrome (MetS), particularly obesity and dyslipidemia, are linked to peripheral neuropathy (PN) among patients with diabetes or even without diabetes. Several studies revealed that complementary and herbal medicine could provide a potential for PN management and MetS components. Thus, designing clinical trials with interventions combinations to achieve a considerable improvement is highly recommended. Hesperidin and diosmin, citrus-derived flavonoids, have been reported to possess anti-hyperlipidemic, anti-inflammatory, analgesic, antioxidant, antidiabetic, and anti-hypertensive effect with high tolerability and safety profile

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

129

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • Egypt
      • Fayoum, Egypt, 13556
        • 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

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Type 2 diabetes adult patients who meet metabolic syndrome criteria and with diabetic neuropathy

Exclusion Criteria:

patients without any parameter of inclusion criteria

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control group
Active Comparator: Diosmin
Dietary supplement: dietary supplement flavonoids
patients were allocated to receive either hesperidin, diosmin, or combination of both and the fourth group was assigned as a control group without intervention
Active Comparator: Hesperidin group
Dietary supplement: dietary supplement flavonoids
patients were allocated to receive either hesperidin, diosmin, or combination of both and the fourth group was assigned as a control group without intervention
Active Comparator: Hesperidin and diosmin
Dietary supplement: dietary supplement flavonoids
patients were allocated to receive either hesperidin, diosmin, or combination of both and the fourth group was assigned as a control group without intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
metabolic syndrome components
Time Frame: 12 weeks
Waist circumference, (cm)
12 weeks
metabolic syndrome components
Time Frame: 12 weeks
FBG, mg/dl
12 weeks
metabolic syndrome components
Time Frame: 12 weeks
LDL, mg/dl
12 weeks
metabolic syndrome components
Time Frame: 12 weeks
HDL
12 weeks
metabolic syndrome components
Time Frame: 12 weeks
TGs, mg/dl
12 weeks
MNSI score for neuropathy
Time Frame: 12 weeks
neuropathy improvement if MNSI score decreased
12 weeks

Collaborators and Investigators

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

Sponsor

Beni-Suef University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

March 1, 2020

Primary Completion (Actual)

November 30, 2020

Study Completion (Actual)

November 12, 2021

Study Registration Dates

First Submitted

February 3, 2022

First Submitted That Met QC Criteria

February 14, 2022

First Posted (Actual)

February 17, 2022

Study Record Updates

Last Update Posted (Actual)

February 17, 2022

Last Update Submitted That Met QC Criteria

February 14, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMBSU REC FWA#: FWA00015574

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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