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RecruitingNCT07745426Updated Aug 4, 2026

Clinical Study Comparing Diosmin vs Rebamipide as Adjuvant Therapies vs Conventional Therapy in Patients With Rheumatoid Arthritis

A Phase 2 interventional study of Diosmin and Rebamipide 100mg in Rheumatoid Arthritis (RA), sponsored by Tanta University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-08-04.

Sponsored by Tanta University · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
66
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

This study will be a randomized controlled parallel study that will be conducted on 66 patients with active rheumatoid arthritis who will be diagnosed with RA according to American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR, 2010). The patients will be recruited from Outpatient Clinic of Rheumatology, Physical Medicine, Rheumatology and Rehabilitation Department, Tanta University Hospital, Tanta, Egypt. The study duration will be 3 months. The patients will be randomized into three groups:

- Group 1 (control group): will include 22 patients who will receive the conventional therapy for RA for 3 months.

- Group 2 (diosmin group): will include 22 patients who will receive the conventional therapy for RA plus 1000 mg diosmin once daily for 3 months.

- Group 3 (rebamipide group): will include 22 patients who will receive the conventional therapy for RA plus 100 mg rebamipide three times daily for 3 months.

02

Conditions studied

  • Rheumatoid Arthritis (RA)

Keywords

  • rheumatoid arthritis
  • diosmin
  • rebamipide
03

In context

Arthritis, Rheumatoid

2,888 studies on the registry are indexed under Arthritis, Rheumatoid; 390 are open to participants now.

This study's planned enrollment of 66 is below the median of 94 across 1,984 interventional studies indexed under Arthritis, Rheumatoid.

Browse Arthritis, Rheumatoid studies →

Lead sponsor

Tanta University is the lead sponsor of 963 studies on the registry; 304 are open to participants now.

Of its 16 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients with active rheumatoid arthritis (not in remission) according to American College of Rheumatology/European League Against Rheumatism (ACR/EULAR). i.e.,28 joints disease activity score (DAS-28) >2.6.
  • Both sexes.
  • Age ranges between 18 and 70 years old.
  • Patients receiving conventional DMARDs

Exclusion criteria

Exclusion Criteria:

  • Pregnant and lactating females.
  • Patients receiving biological DMARDs or targeted synthetic DMARDs.
  • Patients with renal and hepatic dysfunction.
  • Patients with other inflammatory/autoimmune diseases, active infection, or malignancies.
  • Patients with bleeding disorders, receiving warfarin or other anticoagulants.
  • Patients receiving antioxidants.
  • Patients with hypersensitivity to study medications.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
66 participants (estimated)

Study arms

  • Active comparator
    Group 1 (control group):

    will include 22 patients who will receive the conventional therapy for RA for 3 months.

    Drug: Convential medical treatment

  • Active comparator
    Group 2 (diosmin group):

    will include 22 patients who will receive the conventional therapy for RA plus 1000 mg diosmin once daily for 3 months.

    Drug: Diosmin · Drug: Convential medical treatment

  • Active comparator
    Group 3 (rebamipide group):

    will include 22 patients who will receive the conventional therapy for RA plus 100 mg rebamipide three times daily for 3 months.

    Drug: Rebamipide 100mg · Drug: Convential medical treatment

Interventions

  • DrugDiosmin

    1000 mg diosmin once daily for 3 months

  • DrugRebamipide 100mg

    100 mg rebamipide three times daily for 3 months

  • DrugConvential medical treatment

    conventional medical treatment for RA

06

What researchers measure

Primary outcomes

  1. The change in Disease Activity score-CRP (DAS28-CRP)

    disease activity will be assessed through: Calculation of 28-joint count Disease Activity Score (DAS28) using C- reactive protein level (CRP) according to the following formula: DAS28-CRP = \[0.56\*√ (tender joint count) + 0.28\*√ (swollen joint count) + 0.36\*ln (CRP+1)\]\*1.10 + 1.15\]

    Time frame: At baseline and after three months of the intervention

  2. The change in The Health Assessment Questionnaire-Disability Index (HAQ-DI) score

    the functional status of the participants will be assessed through: The Health Assessment Questionnaire-Disability Index (HAQ-DI)

    Time frame: At baseline and after three months of the intervention

Secondary outcomes

  1. The change in serum level of C- reactive protein (CRP)

    Time frame: three months

  2. The change in serum level of Tumor necrosis factor-alpha (TNF-α)

    Time frame: three months

  3. The change in serum level of Matrix metalloproteinase-3 (MMP-3)

    Time frame: three months

07

Study locations

1 of 1 sites recruiting
  • Faculty of Pharmacy Tanta University
    Tanta, Egypt
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07745426
Lead sponsor
Tanta University
Responsible party
Khlood Mohamed Kettana (clinical pharmacy assistant lecturer, Tanta University) — Principal investigator
First posted
Aug 4, 2026
Start date
Aug 1, 2026 (estimated)
Primary completion
Aug 1, 2027 (estimated)
Completion
Aug 1, 2027 (estimated)
Last update
Aug 4, 2026

Study contacts

khlood mohamed kettana, assistant lecturer
Contact
khlood.kettana@pharm.tanta.edu.eg
01091100037

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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