Rheumatoid Arthritis (RA)Phase 2/3NCT07709312
the Effect of Ginkgo Biloba on Rheumatoid Arthritis Patients
A Phase 2/3 study testing Ginkgo Biloba Extract (120 mg ) manufuctured by EMA PHARM in people with Rheumatoid Arthritis (RA) and Manegmentof Rheumatoid Arthritis, run by Ain Shams University.
Trial summary
this study aims to measure The Effect of Gingko Biloba on the Clinical Outcome of Rheumatoid Arthritis Patients ,the outcomes are hsCRp,calprotectin,DAS-28,HAQ-DI Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis (RA), Manegmentof Rheumatoid Arthritis
- What is being tested?
- Ginkgo Biloba Extract (120 mg ) manufuctured by EMA PHARM
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2026to 15 Jan 2027
- Phase
- Phase 2/3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (older than 18 years) -
- With moderate to high disease activity defined as DAS-28 score ≥ 3.2
- Patients receiving stable regimen of one or more csDMARDs for the past 6 months Exclusion criteria
- Patients with known hypersensitivity to Ginkgo biloba
- Patients receiving Ginkgo biloba for any other indications
- Patients on biologic DMARDs
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- Patients with impaired liver functions (liver transaminases level ≥ three times upper normal limits), impaired kidney functions (estimated glomerular filtration rate (eGFR) < 30 ml/min),
- Patients with any of the following comorbidities: congestive heart failure, history of myocardial infarction, severe anemia, active infections, other inflammatory diseases, and malignancies.
- Patients with other autoimmune diseases
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effect of Gingko Biloba on the Clinical Outcome of Rheumatoid Arthritis Patients
this study aims to measure The Effect of Gingko Biloba on the Clinical Outcome of Rheumatoid Arthritis Patients ,the outcomes are hsCRp,calprotectin,DAS-28,HAQ-DI
Read the detailed description
Rheumatoid arthritis (RA) is a systemic progressive inflammatory disease characterized by joint injury and cartilage destruction. Up-regulation of T-helper17 (Th17) cells and down-regulation of regulatory T (Treg) cells are among the features of RA pathogenesis which led to inflammation.The first line management strategy of RA is based on using conventional synthetic disease modifying anti-rheumatic drugs
, however,many RA patients either do not respond or develop resistant to csDMARDs. Meanwhile, several biologic DMARDs have been reported to improve RA outcomes but the high cost make them unaffordable for many patients. Hence, alternative low-cost strategies are needed to control RA disease activity and improve patients' QOL.
Ginkgolide B (GB) is an extract of the leaves of Ginkgo biloba containing terpene lactones (which most notably include ginkgolides and diterpenes) and ginkgo flavone glycosides (which most notably contain ginkgetin, bilobetin, and sciadopitysin). The anti-inflammatory and anti-apoptotic activities of GB have been proven in diabetes and osteoarthritis. GBLE has also an antioxidant action as a free radical scavenger, an improving effect on blood flow or microcirculation, and a stimulating effect on neurotransmitters. However, to the best of our knowledge, no studies have evaluated the benefits of GB in RA patients.
Thus, the current study is the first randomized controlled trial to evaluate the efficacy and safety of GB on inflammation and quality of life in RA patients.
- Being tested
- Ginkgo Biloba Extract (120 mg ) manufuctured by EMA PHARM
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ginkgo Biloba Extract (120 mg ) manufuctured by EMA PHARMDrug
Ginkgo biloba leaf extract (GBLE) has an antioxidant action as a free radical scavenger, an improving effect on blood flow or microcirculation, and a stimulating effect on neurotransmitters. Besides a direct scavenging action on active oxygen species, GBLE exerts an anti-inflammatory effect on inflammatory cells by suppressing the production of active oxygen and nitrogen species. GBLE inhibited the increase in the products of the oxidative decomposition low-density lipoprotein (LDL), reduced the cell death in various types of neuropathies, and prevented the oxidative damage to mitochondria
| Study group | Role | What they receive |
|---|---|---|
| ginkgo biloba group | Experimental | Ginkgo biloba group: 25 patients will receive Ginkgo biloba treatment (120 mg twice daily for 12 weeks) in addition to their standard treatment. Receives: Drug: Ginkgo Biloba Extract (120 mg ) manufuctured by EMA PHARM |
| control group | No intervention | Control group: 25 patients will receive standard treatment for 12 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
HsCRP
- Blood samples will be drawn from the patients at baseline and after 12 weeks of intervention Blood samples will be collected at baseline ,centrifuged and stored as serum at -80 °C until analysis.
- Hs-CRP will be evaluated by for each patient at baseline and after 12 weeks using commercial ELISA kits
Measured: baseline and 12 weeks
Secondary outcomes (3)
calprotectin
Enzyme-linked immunosorbent assay (ELISA) method will be used to measure calprotectin concentrations at base line and after 12 weeks
Measured: baseline and 12weeks
DAS-28
Disease activity will be assessed using DAS-28-CRP scale which required physical examination of specific 28 joints by a blinded rheumatologist to evaluate tender joints count (TJC) and swollen joints count (SJC), serum CRP levels, and patient global health assessment (GH) of disease severity assessed on a scale from 0 to 100 mm. The activity score can be calculated according to the following formula
Measured: baseline and 12 weeks
Quality of life assessment
Patient's QOL will be assessed by Health Assessment Questionnaire Disability index (HAQ-DI) (Yoshikawa, Naito et al.1999). It comprises eight categories assessing the ability of patients to perform activities of daily living. Each category includes two or three questions scored from 0 (without any difficulty) to 3 (unable to do). The score of each category is the highest score among the scores of the included questions. If an aid or assistance device is used or if help is required from another individual, then the minimum score for that section is 2. The final score is calculated by summation of the scores for various categories divided by the number of categories resulting in a score from 0 to 3 where higher scores indicate poor QOL. The QOL scale is presented in the appendix.
Measured: baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start15 Oct 2026 (estimated)
- Primary completion15 Jan 2027 (estimated)
- Study completion15 Jan 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 Ain Shams 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nuran Sameh, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07709312
- Sponsor's protocol ID
- RHDIRB2020110301 REC#460
- Status last verified
- Oct 2026
- First submitted
- 12 Jul 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Gingko Biloba on the Clinical Outcome of Rheumatoid Arthritis Patients
- ClinicalTrials.gov ID
- NCT07709312
- Acronym / sponsor ID
- RHDIRB2020110301 REC#460
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 15 Jan 2027 (estimated)
- Study completion
- 15 Jan 2027 (estimated)
- First posted
- 16 Jul 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 aims to measure The Effect of Gingko Biloba on the Clinical Outcome of Rheumatoid Arthritis Patients ,the outcomes are hsCRp,calprotectin,DAS-28,HAQ-DI
Detailed description
Rheumatoid arthritis (RA) is a systemic progressive inflammatory disease characterized by joint injury and cartilage destruction. Up-regulation of T-helper17 (Th17) cells and down-regulation of regulatory T (Treg) cells are among the features of RA pathogenesis which led to inflammation.The first line management strategy of RA is based on using conventional synthetic disease modifying anti-rheumatic drugs
, however,many RA patients either do not respond or develop resistant to csDMARDs. Meanwhile, several biologic DMARDs have been reported to improve RA outcomes but the high cost make them unaffordable for many patients. Hence, alternative low-cost strategies are needed to control RA disease activity and improve patients' QOL.
Ginkgolide B (GB) is an extract of the leaves of Ginkgo biloba containing terpene lactones (which most notably include ginkgolides and diterpenes) and ginkgo flavone glycosides (which most notably contain ginkgetin, bilobetin, and sciadopitysin). The anti-inflammatory and anti-apoptotic activities of GB have been proven in diabetes and osteoarthritis. GBLE has also an antioxidant action as a free radical scavenger, an improving effect on blood flow or microcirculation, and a stimulating effect on neurotransmitters. However, to the best of our knowledge, no studies have evaluated the benefits of GB in RA patients.
Thus, the current study is the first randomized controlled trial to evaluate the efficacy and safety of GB on inflammation and quality of life in RA patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ginkgo biloba group | Experimental | Drug: Ginkgo Biloba Extract (120 mg ) manufuctured by EMA PHARMGinkgo biloba group: 25 patients will receive Ginkgo biloba treatment (120 mg twice daily for 12 weeks) in addition to their standard treatment. |
| control group | No intervention | –Control group: 25 patients will receive standard treatment for 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adult patients (older than 18 years) -
- With moderate to high disease activity defined as DAS-28 score ≥ 3.2
- Patients receiving stable regimen of one or more csDMARDs for the past 6 months Exclusion criteria
- Patients with known hypersensitivity to Ginkgo biloba
- Patients receiving Ginkgo biloba for any other indications
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Ginkgo Biloba Extract (120 mg ) manufuctured by EMA PHARMGinkgo biloba leaf extract (GBLE) has an antioxidant action as a free radical scavenger, an improving effect on blood flow or microcirculation, and a stimulating effect on neurotransmitters. Besides a direct scavenging action on active oxygen species, GBLE exerts an anti-inflammatory effect on inflammatory cells by suppressing the production of active oxygen and nitrogen species. GBLE inhibited the increase in the products of the oxidative decomposition low-density lipoprotein (LDL), reduced the cell death in various types of neuropathies, and prevented the oxidative damage to mitochondria | Drug | ginkgo biloba group |
Primary outcome
HsCRP
Time frame: baseline and 12 weeks
* Blood samples will be drawn from the patients at baseline and after 12 weeks of intervention Blood samples will be collected at baseline ,centrifuged and stored as serum at -80 °C until analysis. * Hs-CRP will be evaluated by for each patient at baseline and after 12 weeks using commercial ELISA kits
3 secondary outcomes
calprotectin
Time frame: baseline and 12weeks
DAS-28
Time frame: baseline and 12 weeks
Quality of life assessment
Time frame: baseline and 12 weeks
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 6 Oct 2026.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Ginkgo Biloba Extract (120 mg ) manufuctured by EMA PHARM in people with Rheumatoid Arthritis (RA) and Manegmentof Rheumatoid Arthritis, run by Ain Shams University.
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 9 inclusion and 0 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: opening soon, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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 combined 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.
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 noran sameh ahmed, bachelor degree in pharmacy (201068397368, nuran.sameh@pharma.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HsCRP (time frame: baseline and 12 weeks). 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 6 Oct 2026.