Effect of Diosmin and Hesperidin in Treatment of Patients With Rheumatoid Arthritis

NCT05756179 — Phase 3, Recruiting, 80 participants, Alexandria University

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

Clinical Study Evaluating the Effect of Diosmin and Hesperidin in Treatment of Patients With Rheumatoid Arthritis

Registry	NCT05756179
Status	Recruiting
Phase	Phase 3
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	80 (Estimated)
Sponsor	Alexandria University (Other)
Conditions	Rheumatoid Arthritis
Interventions	Diosmin and Hesperidin Combination (Drug)
Dates	start 2023-07-18, primary completion 2025-09-01 (estimated), completion 2026-09-01 (estimated), first posted 2023-03-06, last updated 2025-04-25
Locations	1 site in Egypt

-Summary

Evaluating the effect of the flavonoids combination (diosmin and hesperidin) as adjuvant therapy on patients with rheumatoid arthritis

Expand all sections · Collapse all

+Detailed description

Evaluation of the anti inflammatory and antioxidant effects of the flavonoids combination (diosmin and hesperidin) as adjuvant therapy on patients with rheumatoid arthritis.

Clinical and functional assessment of disease activity.

Evaluation of hepatoprotective effect against methotrexate induced liver adverse events.

+Arms and interventions

Arm	Type	Interventions	Description
Intervention group	Active comparator	Drug: Diosmin and Hesperidin Combination	Diosmin 450 mg and Hesperidin 50 mg Combination /tablet/ twice daily for 3 months + Conventional Therapy (Methotrexate)
Control group	No intervention		Conventional Therapy (Methotrexate) only

Diosmin and Hesperidin Combination (Drug), also known as Diosmin Plus 500 mg tablet: Diosmin 450 mg and Hesperidin 50 mg Combination

+Outcome measures

Primary outcomes

Anti inflammatory Effect [3 months]: Measure the change in serum level of IL-1β (interleukin 1β) at baseline and after treatment in both groups
Effect on disease activity [3 months]: Measure the change in the disease activity at baseline and after 3 months of therapy for each patient in both groups using Disease Activity Score-CRP (DAS28-CRP) which is calculated by a computer based formula consists of several variables: number of swollen joints (0-28), number of tender joints (0-28) and C reactive protein (CRP) (mg/l). A DAS28 value of >5.1 indicates high disease activity, DAS28 ranged from 3.3 to 5.1 indicates moderate disease activity and DAS28 ≤3.2 indicates low disease activity.

Secondary outcomes

Hepatoprotective Effect [3 months]: Measure the change in serum level of Liver enzymes (ALT \& AST) at baseline and after treatment in both groups.

+Eligibility

Sex: All, ages: 19 Years to 65 Years

Inclusion Criteria:

* Patients with mild to moderate disease activity.
* Patient age must be more than 18 years.

Exclusion Criteria:

* Pregnant and lactating females.
* Patients with liver, renal impairment or any other inflammatory diseases.
* Patients on TNF-α (tumor necrosis factor- α) or IL-1β (interleukin-1β) antagonists.

+Locations (1)

Facility	City	Country	Status
Alexandria university hospital	Alexandria	Egypt	Recruiting

+Investigators

AHMED ABDELBAR, MSc, Principal investigator, College of Pharmacy - Arab Academy for Science and Technology
AHMED ELMALLAH, PhD, Study chair, Faculty of Pharmacy - Alexandria University
MANAL TAYEL, MD, Study chair, Faculty of Medicine - Alexandria Univeristy
ABEER IBRAHIM, MD, Study chair, Faculty of Medicine - Alexandria Univeristy
NOHA HAMDI, PhD, Study director, Faculty of Pharmacy - Alexandria University