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

Alexandria University

Status and phase: Enrolling; Phase 3

Conditions: Rheumatoid Arthritis

Treatments: Drug: Diosmin and Hesperidin Combination

Study type: Interventional

Funder types: Other

Identifiers

NCT05756179

0201734

Details and patient eligibility

About

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

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 19 to 65 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

80 participants in 2 patient groups

Intervention group

Active Comparator group

Description:

Diosmin 450 mg and Hesperidin 50 mg Combination /tablet/ twice daily for 3 months + Conventional Therapy (Methotrexate)

Treatment:

Drug: Diosmin and Hesperidin Combination

Control group

No Intervention group

Description:

Conventional Therapy (Methotrexate) only