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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05756179
• Other study ID #: 0201734
• Status: Recruiting
• Phase: Phase 3
• Start date: July 18, 2023
• Est. completion date: September 2025

Study information

• Verified date: February 2023
• Source: Alexandria University
• Contact: AHMED ABDELBAR, MSc
• Phone: 00201021914588
• Email: dr.ahmed_post[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: September 2025
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 65 Years

Eligibility

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-a or IL-1ß antagonists.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Diosmin and Hesperidin Combination
Diosmin 450 mg and Hesperidin 50 mg Combination

Locations

Country	Name	City	State
Egypt	Alexandria university hospital	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anti inflammatory Effect	Measure the change in serum level of IL-1ß at baseline and after treatment in both groups	3 months
Primary	Effect on disease activity	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.	3 months
Secondary	Hepatoprotective Effect	Measure the change in serum level of Liver enzymes (ALT & AST) at baseline and after treatment in both groups.	3 months