Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07709312

the Effect of Ginkgo Biloba on 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

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Rheumatoid Arthritis (RA) Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Manegmentof Rheumatoid Arthritis Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

1. Adult patients (older than 18 years) 2. With moderate to high disease activity defined as DAS-28 score ≥ 3.2 3. Patients receiving stable regimen of one or more csDMARDs for the past 6 months

-

Exclusion criteria

  • 1. Patients with known hypersensitivity to Ginkgo biloba 2. Patients receiving Ginkgo biloba for any other indications 3. Patients on biologic DMARDs 4. Patients with impaired liver functions (liver transaminases level ≥ three times upper normal limits), impaired kidney functions (estimated glomerular filtration rate (eGFR) < 30 ml/min), 5. 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

Treatment and study plan

Ginkgo Biloba Extract (120 mg ) manufuctured by EMA PHARM

Drug

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

Primary outcomes

  1. 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

Secondary outcomes

  1. calprotectin

    Time frame: baseline and 12weeks

    Enzyme-linked immunosorbent assay (ELISA) method will be used to measure calprotectin concentrations at base line and after 12 weeks

  2. DAS-28

    Time frame: baseline and 3 months

    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

  3. Quality of life assessment

    Time frame: at baseline and after 12 weeks

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

noran sameh ahmed, bachelor degree in pharmacy

CONTACT

[email protected]

201068397368

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

The Effect of Gingko Biloba on the Clinical Outcome of Rheumatoid Arthritis Patients

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 16, 2026
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.