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

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Primary Purpose

Status

Not yet recruiting

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Diosmin and Hesperidin Combination

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

19 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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 or IL-1β antagonists.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Intervention group

Control group

Arm Description

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

Conventional Therapy (Methotrexate) only

Outcomes

Primary Outcome Measures

Anti inflammatory Effect

Measure the change in serum level of IL-1β at baseline and after treatment in both groups

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.

Secondary Outcome Measures

Hepatoprotective Effect

Measure the change in serum level of Liver enzymes (ALT & AST) at baseline and after treatment in both groups.

Full Information

NCT ID

NCT05756179

First Posted

February 21, 2023

Last Updated

March 3, 2023

Sponsor

Alexandria University

1. Study Identification

Unique Protocol Identification Number

NCT05756179

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

July 2023 (Anticipated)

Primary Completion Date

September 2024 (Anticipated)

Study Completion Date

September 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Alexandria University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rheumatoid Arthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intervention group

Arm Type

Active Comparator

Arm Description

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

Arm Title

Control group

Arm Type

No Intervention

Arm Description

Conventional Therapy (Methotrexate) only

Intervention Type

Drug

Intervention Name(s)

Diosmin and Hesperidin Combination

Other Intervention Name(s)

Dafrex tablet, Diosmin Plus 500 mg tablet

Intervention Description

Diosmin 450 mg and Hesperidin 50 mg Combination

Primary Outcome Measure Information:

Title

Anti inflammatory Effect

Description

Measure the change in serum level of IL-1β at baseline and after treatment in both groups

Time Frame

3 months

Title

Effect on disease activity

Description

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.

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Hepatoprotective Effect

Description

Measure the change in serum level of Liver enzymes (ALT & AST) at baseline and after treatment in both groups.

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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 or IL-1β antagonists.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

AHMED ABDELBAR, MSc

Phone

00201021914588

Email

dr.ahmed_post@yahoo.com

Overall Study Officials: