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

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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05756179

Enrollment

Registered

2023-03-06

Start date

2023-07-18

Completion date

2026-09-30

Last updated

2025-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Brief summary

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

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.

Interventions

DRUGDiosmin and Hesperidin Combination

Diosmin 450 mg and Hesperidin 50 mg Combination

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Hepatoprotective Effect	3 months	Measure the change in serum level of Liver enzymes (ALT & AST) at baseline and after treatment in both groups.

Countries

Egypt

Contacts

Primary ContactAHMED ABDELBAR, MSc

dr.ahmed_post@yahoo.com00201021914588

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026