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IRCT20191221045837N4 IRCT 2021-12-08 Mashhad University of Medical Sciences Evaluation of the Efficacy of Ginger Supplementation with Pellet Formulation in Children with Juvenile Idiopathic Arthritis(JIA) Evaluation of the Efficacy of Ginger Supplementation with Pellet Formulation in Children with Juvenile Idiopathic Arthritis(JIA) 2022-01-05 anticipated 50 Complete https://irct.ir/trial/51039 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization Randomization tool: https://www.sealedenvelope.com/ How to make a random sequence: To perform this method, the number of intervention groups (two groups A and B), the volume of each block (4 in each block) and sample size (50 patients) were entered into the website. Then, the site creates a randomization list of 13 blocks, each contains 4 patients, Blinding description: Patients, evaluators, data analysts, and technicians are blinded. N/A juvenile idiopathic arthritis (JIA). Intervention 1: Intervention group: included patients will receive standard treatment of JIA and ginger pellets (containing hydro-alcoholic ginger extract equivalent to 250 mg of ginger rhizome powder, standardized based on Shogaol and phenolic acids contents) twice a day for 3 months. Intervention 2: Control group: Included patients will receive standard treatment of JIA and placebo pellets (twice daily) for 3 months. Yes - There is a plan to make this available What will be shared: At the end of study, all medical records of patients will be shared. When: The access period starts 6 months after the publication. To whom: Researchers affiliated to academic, scientific and industrial institutes Conditions: No one is allowed to use the documents except the principal researcher. Where to obtain: Send an email to Dr. Zeinat Heydari. heidarizn@mums.ac.ir How to obtain: Send an email to Dr. Zeinat Heydari. heidarizn@mums.ac.ir Comments:
public Zinat Heidari
Faculty of Pharmacy, University Campus, Azadi Square, Mashhad, Khorasan Razavi.
Mashhad Iran (Islamic Republic of) 9177948954 +98 51 3180 1584 heidarizn@mums.ac.ir Mashhad University of Medical Sciences scientific Zinat Heidari
Faculty of Pharmacy, University Campus, Azadi Square, Mashhad, Khorasan Razavi.
Mashhad Iran (Islamic Republic of) 9177948954 +98 51 3180 1584 heidarizn@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Children (aged 6-16 years) referred to rheumatology clinic of Akbar hospital, who have been diagnosed with JIA according to the ACR Guideline. Obtaining informed consent of the patient / patient's parents 6 years 16 years Both A child with a history of underlying disease, including cardiac, renal, hepatic, biliary, gastrointestinal, or rheumatic disorders (other than JIA), at the time of enrollment Use of anticoagulants (such as warfarin) or antiplatelet agents Diabetic patients M08 Juvenile arthritis Treatment - Drugs Treatment - Drugs Intervention group: included patients will receive standard treatment of JIA and ginger pellets (containing hydro-alcoholic ginger extract equivalent to 250 mg of ginger rhizome powder, standardized based on Shogaol and phenolic acids contents) twice a day for 3 months. Control group: Included patients will receive standard treatment of JIA and placebo pellets (twice daily) for 3 months. Disease severity will be assessed at baseline, end of the first month, and end of the third month of treatment using the ACR-Pedi30 Score. The core criteria for ACR Pedi 30 score are: 1) physician global assessment of disease activity (PhGA); 2) parent/patient global assessment of overall well-being; 3) functional ability; 4) number of joints with active arthritis; 5) number of joints with limited range of motion; and 6) ESR. Timepoint: At baseline, end of the first month, and end of the third month of treatment. Method of measurement: 1) physician global assessment of disease activity (PhGA); 2) parent/patient global assessment of overall well-being; 3) functional ability; 4) number of joints with active arthritis; 5) number of joints with limited range of motion; and 6) ESR. Mashhad University of Medical Sciences Approved 2020-10-10 Ethics committee of Mashhad University of Medical Sciences Central department of Mashhad University of Medical Sciences, next to Alton Tower, Daneshgah Street, Mashhad, Khorasan Razavi Province, Iran. Mashhad Razavi Khorasan Iran (Islamic Republic of)