the Effect of Ginkgo Biloba on Rheumatoid Arthritis Patients
Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorAin Shams University
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Patients with known hypersensitivity to Ginkgo biloba
Patients receiving Ginkgo biloba for any other indications
Patients on biologic DMARDs
Patients with impaired liver functions (liver transaminases level ≥ three times upper normal limits), impaired kidney functions (estimated glomerular filtration rate (eGFR) < 30 ml/min),
Trial design
Design model
Parallel
Treatments tested in this trial
Ginkgo Biloba Extract (120 mg ) manufuctured by EMA PHARM
DrugGinkgo 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
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: ginkgo biloba groupExperimental treatment 1 intervention
Group B: control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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
Time frame
baseline and 12 weeksSecondary outcomes
1
calprotectin
Enzyme-linked immunosorbent assay (ELISA) method will be used to measure calprotectin concentrations at base line and after 12 weeks
Time frame
baseline and 12weeks2
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
Time frame
baseline and 12 weeks3
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.
Time frame
baseline and 12 weeksLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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