Hesperidin and Diosmin Effect on Metabolic Syndrome

• Sponsor: Beni-Suef University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05243238
• Collaborator: (none)
• Enrollment: 129
• Location: 1
• Arms: 4
• Actual Duration (Months): 20.4
• Patients Per Site Per Month: 6.3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Metabolic Syndrome and Diabetic Neuropathy	Dietary Supplement: dietary supplement flavonoids	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 129 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Hesperidin-Diosmin Effect on Metabolic Syndrome and Diabetic Neuropathy Among Patients With Type 2 Diabetes Mellitus
• Actual Study Start Date: Mar 1, 2020
• Actual Primary Completion Date: Nov 30, 2020
• Actual Study Completion Date: Nov 12, 2021

Arms and Interventions

Arm	Intervention/Treatment
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: 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 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
No Intervention: control group

Outcome Measures

Primary Outcome Measures

1. metabolic syndrome components [12 weeks]

   Waist circumference, (cm)

2. metabolic syndrome components [12 weeks]

   FBG, mg/dl

3. metabolic syndrome components [12 weeks]

   LDL, mg/dl

4. metabolic syndrome components [12 weeks]

   HDL

5. metabolic syndrome components [12 weeks]

   TGs, mg/dl

6. MNSI score for neuropathy [12 weeks]

   neuropathy improvement if MNSI score decreased

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University	Fayoum		Egypt	13556

Sponsors and Collaborators

• Beni-Suef University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hasnaa Osama, Lecturer of clinical pharmacy, Beni-Suef University
• ClinicalTrials.gov Identifier: NCT05243238
• Other Study ID Numbers: FMBSU REC FWA#: FWA00015574
• First Posted: Feb 17, 2022
• Last Update Posted: Feb 17, 2022
• Last Verified: Feb 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Diabetic Neuropathies; Metabolic Syndrome; Syndrome

Study Results

No Results Posted as of Feb 17, 2022