Rheumatoid Arthritis (RA)Phase 2NCT07745426
Clinical Study Comparing Diosmin vs Rebamipide as Adjuvant Therapies vs Conventional Therapy in Patients With Rheumatoid Arthritis
A Phase 2 study testing Diosmin, Rebamipide 100mg and Convential medical treatment in people with Rheumatoid Arthritis (RA), run by Tanta University at 1 site in Egypt.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Rheumatoid Arthritis (RA)
- What is being tested?
- Diosmin, Rebamipide 100mg and Convential medical treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2026to 1 Aug 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
- Conditions
- Rheumatoid Arthritis (RA)
- Being tested
- Diosmin, Rebamipide 100mg, Convential medical treatment
- Keywords
- rheumatoid arthritis, diosmin, rebamipide
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiosminDrug
1000 mg diosmin once daily for 3 months
Rebamipide 100mgDrug
100 mg rebamipide three times daily for 3 months
Convential medical treatmentDrug
conventional medical treatment for RA
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (control group): | Active comparator | will include 22 patients who will receive the conventional therapy for RA for 3 months. Receives: Drug: Convential medical treatment |
| Group 2 (diosmin group): | Active comparator | will include 22 patients who will receive the conventional therapy for RA plus 1000 mg diosmin once daily for 3 months. Receives: Drug: Diosmin; Drug: Convential medical treatment |
| Group 3 (rebamipide group): | Active comparator | will include 22 patients who will receive the conventional therapy for RA plus 100 mg rebamipide three times daily for 3 months. Receives: Drug: Rebamipide 100mg; Drug: Convential medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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]
Measured: At baseline and after three months of the intervention
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)
Measured: At baseline and after three months of the intervention
Secondary outcomes (3)
The change in serum level of C- reactive protein (CRP)
Measured: three months
The change in serum level of Tumor necrosis factor-alpha (TNF-α)
Measured: three months
The change in serum level of Matrix metalloproteinase-3 (MMP-3)
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid Arthritis (RA)Studies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khlood Mohamed Kettana, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07745426
- Sponsor's protocol ID
- 36265MD41021/1/26
- Status last verified
- Jul 2026
- First submitted
- 29 Jul 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study Comparing Diosmin vs Rebamipide as Adjuvant Therapies vs Conventional Therapy in Patients With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT07745426
- Acronym / sponsor ID
- 36265MD41021/1/26
- Conditions
- Rheumatoid Arthritis (RA)
- Keywords
- rheumatoid arthritis, diosmin, rebamipide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 4 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 (control group): | Active comparator | Drug: Convential medical treatmentwill include 22 patients who will receive the conventional therapy for RA for 3 months. |
| Group 2 (diosmin group): | Active comparator | Drug: Diosmin, Drug: Convential medical treatmentwill include 22 patients who will receive the conventional therapy for RA plus 1000 mg diosmin once daily for 3 months. |
| Group 3 (rebamipide group): | Active comparator | Drug: Rebamipide 100mg, Drug: Convential medical treatmentwill include 22 patients who will receive the conventional therapy for RA plus 100 mg rebamipide three times daily for 3 months. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diosmin1000 mg diosmin once daily for 3 months | Drug | Group 2 (diosmin group): |
| Rebamipide 100mg100 mg rebamipide three times daily for 3 months | Drug | Group 3 (rebamipide group): |
| Convential medical treatmentconventional medical treatment for RA | Drug | Group 1 (control group):, Group 2 (diosmin group):, Group 3 (rebamipide group): |
Primary outcome
The change in Disease Activity score-CRP (DAS28-CRP)
Time frame: At baseline and after three months of the intervention
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]
The change in The Health Assessment Questionnaire-Disability Index (HAQ-DI) score
Time frame: At baseline and after three months of the intervention
the functional status of the participants will be assessed through: The Health Assessment Questionnaire-Disability Index (HAQ-DI)
3 secondary outcomes
The change in serum level of C- reactive protein (CRP)
Time frame: three months
The change in serum level of Tumor necrosis factor-alpha (TNF-α)
Time frame: three months
The change in serum level of Matrix metalloproteinase-3 (MMP-3)
Time frame: three months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Diosmin, Rebamipide 100mg and Convential medical treatment in people with Rheumatoid Arthritis (RA), run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact khlood mohamed kettana, assistant lecturer (01091100037, khlood.kettana@pharm.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in Disease Activity score-CRP (DAS28-CRP) (time frame: At baseline and after three months of the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.