Rheumatoid ArthritisPhase 3NCT05756179
Effect of Diosmin and Hesperidin in Treatment of Patients With Rheumatoid Arthritis
A Phase 3 study testing Diosmin and Hesperidin Combination in people with Rheumatoid Arthritis, run by Alexandria University at 1 site in Egypt.
Trial summary
Evaluating the effect of the flavonoids combination (diosmin and hesperidin) as adjuvant therapy on patients with rheumatoid arthritis Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Diosmin and Hesperidin Combination
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 18 Jul 2023to Sep 2026
- Phase
- Phase 3
- 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 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with mild to moderate disease activity.
- Patient age must be more than 18 years.
Who cannot join
- 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 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
Official title: Clinical Study Evaluating the Effect of Diosmin and Hesperidin in Treatment of Patients With Rheumatoid Arthritis
Evaluating the effect of the flavonoids combination (diosmin and hesperidin) as adjuvant therapy on patients with rheumatoid arthritis
Read the 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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Diosmin and Hesperidin Combination
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diosmin and Hesperidin CombinationDrug
Also called Diosmin Plus 500 mg tablet
Diosmin 450 mg and Hesperidin 50 mg Combination
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Active comparator | Diosmin 450 mg and Hesperidin 50 mg Combination /tablet/ twice daily for 3 months + Conventional Therapy (Methotrexate) Receives: Drug: Diosmin and Hesperidin Combination |
| Control group | No intervention | Conventional Therapy (Methotrexate) only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti inflammatory Effect
Measure the change in serum level of IL-1β (interleukin 1β) at baseline and after treatment in both groups
Measured: 3 months
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.
Measured: 3 months
Secondary outcomes (1)
Hepatoprotective Effect
Measure the change in serum level of Liver enzymes (ALT \& AST) at baseline and after treatment in both groups.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2023
- Study start18 Jul 2023
- Primary completionSep 2025 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Alexandria 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- AHMED ABDELBAR, MSc, Principal investigator, College of Pharmacy - Arab Academy for Science and TechnologyAHMED ELMALLAH, PhD, Study chair, Faculty of Pharmacy - Alexandria UniversityMANAL TAYEL, MD, Study chair, Faculty of Medicine - Alexandria UniveristyABEER IBRAHIM, MD, Study chair, Faculty of Medicine - Alexandria UniveristyNOHA HAMDI, PhD, Study director, Faculty of Pharmacy - Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05756179
- Sponsor's protocol ID
- 0201734
- Status last verified
- Apr 2025
- First submitted
- 21 Feb 2023
- Last updated
- 25 Apr 2025
- 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 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study Evaluating the Effect of Diosmin and Hesperidin in Treatment of Patients With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT05756179
- Acronym / sponsor ID
- 0201734
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 18 Jul 2023 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 6 Mar 2023 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Active comparator | Drug: Diosmin and Hesperidin CombinationDiosmin 450 mg and Hesperidin 50 mg Combination /tablet/ twice daily for 3 months + Conventional Therapy (Methotrexate) |
| Control group | No intervention | –Conventional Therapy (Methotrexate) only |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with mild to moderate disease activity.
- Patient age must be more than 18 years.
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| Diosmin and Hesperidin CombinationAlso: Diosmin Plus 500 mg tabletDiosmin 450 mg and Hesperidin 50 mg Combination | Drug | Intervention group |
Primary outcome
Anti inflammatory Effect
Time frame: 3 months
Measure the change in serum level of IL-1β (interleukin 1β) at baseline and after treatment in both groups
Effect on disease activity
Time frame: 3 months
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.
1 secondary outcome
Hepatoprotective Effect
Time frame: 3 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 25 Apr 2025.
- 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.
AHMED ABDELBAR, MSc principal investigator
College of Pharmacy - Arab Academy for Science and Technology
AHMED ELMALLAH, PhD study chair
Faculty of Pharmacy - Alexandria University
MANAL TAYEL, MD study chair
Faculty of Medicine - Alexandria Univeristy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Diosmin and Hesperidin Combination in people with Rheumatoid Arthritis, run by Alexandria 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 2 inclusion and 3 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 25 Apr 2025. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 AHMED ABDELBAR, MSc (00201021914588, dr.ahmed_post@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anti inflammatory Effect (time frame: 3 months). 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 25 Apr 2025.