Hesperidin and Diosmin Effect on Metabolic Syndrome

NCT ID: NCT05243238

Last Updated: 2022-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

129 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-01

Study Completion Date

2021-11-12

Brief Summary

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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

Detailed Description

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Conditions

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Metabolic Syndrome and Diabetic Neuropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Hesperidin group

Group Type ACTIVE_COMPARATOR

dietary supplement flavonoids

Intervention Type DIETARY_SUPPLEMENT

patients were allocated to receive either hesperidin, diosmin, or combination of both and the fourth group was assigned as a control group without intervention

Diosmin

Group Type ACTIVE_COMPARATOR

dietary supplement flavonoids

Intervention Type DIETARY_SUPPLEMENT

patients were allocated to receive either hesperidin, diosmin, or combination of both and the fourth group was assigned as a control group without intervention

Hesperidin and diosmin

Group Type ACTIVE_COMPARATOR

dietary supplement flavonoids

Intervention Type DIETARY_SUPPLEMENT

patients were allocated to receive either hesperidin, diosmin, or combination of both and the fourth group was assigned as a control group without intervention

control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

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

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beni-Suef University

OTHER

Sponsor Role lead

Responsible Party

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Hasnaa Osama

Lecturer of clinical pharmacy

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University

Al Fayyum, , Egypt

Site Status

Countries

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Egypt

References

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Osama H, Hamed EO, Mahmoud MA, Abdelrahim MEA. The Effect of Hesperidin and Diosmin Individually or in Combination on Metabolic Profile and Neuropathy among Diabetic Patients with Metabolic Syndrome: A Randomized Controlled Trial. J Diet Suppl. 2023;20(5):749-762. doi: 10.1080/19390211.2022.2107138. Epub 2022 Aug 10.

Reference Type DERIVED
PMID: 35946912 (View on PubMed)

Other Identifiers

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FMBSU REC FWA#: FWA00015574

Identifier Type: -

Identifier Source: org_study_id

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