the Effect of Ginkgo Biloba on Rheumatoid Arthritis Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ginkgo Biloba Extract (120 mg ) manufuctured by EMA PHARM.
- Who it may be relevant to
- Registry conditions: Rheumatoid Arthritis (RA), Manegmentof Rheumatoid Arthritis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Effect of Gingko Biloba on the Clinical Outcome of Rheumatoid Arthritis Patients
Overview
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.
Interventions
- 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
Primary outcome measures
- HsCRP [Time frame: baseline and 12 weeks]
Secondary outcome measures (3)
- calprotectin [Time frame: baseline and 12weeks]
- DAS-28 [Time frame: baseline and 3 months]
- Quality of life assessment [Time frame: at baseline and after 12 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07709312 · RHDIRB2020110301 REC#460