the Effect of Ginkgo Biloba on Rheumatoid Arthritis Patients

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

Study Overview

• Status: Not yet recruiting
• Conditions: Rheumatoid Arthritis (RA); Manegmentof Rheumatoid Arthritis
• Intervention / Treatment: Drug: Ginkgo Biloba Extract (120 mg ) manufuctured by EMA PHARM

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 Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: noran sameh ahmed, bachelor degree in pharmacy; Phone Number: 201068397368; Email: nuran.sameh@pharma.asu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

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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.

6. Patients with other autoimmune diseases

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ginkgo biloba group; Ginkgo biloba group: 25 patients will receive Ginkgo biloba treatment (120 mg twice daily for 12 weeks) in addition to their standard treatment.	Drug: Ginkgo Biloba Extract (120 mg ) manufuctured by EMA PHARM; 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
No Intervention: control group; Control group: 25 patients will receive standard treatment for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	baseline and 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
calprotectin	Enzyme-linked immunosorbent assay (ELISA) method will be used to measure calprotectin concentrations at base line and after 12 weeks	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	baseline and 3 months
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.	at baseline and after 12 weeks

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Estimated): July 15, 2026
• Primary Completion (Estimated): October 15, 2026
• Study Completion (Estimated): October 15, 2026

Study Registration Dates

• First Submitted: July 12, 2026
• First Submitted That Met QC Criteria: July 12, 2026
• First Posted (Actual): July 16, 2026

Study Record Updates

• Last Update Posted (Actual): July 16, 2026
• Last Update Submitted That Met QC Criteria: July 12, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Skin and Connective Tissue Diseases; Arthritis, Rheumatoid; Ginkgo biloba extract
• Other Study ID Numbers: RHDIRB2020110301 REC#460

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No