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IRCT20191221045837N1 IRCT 2020-09-28 Mashhad University of Medical Sciences Effect of Nano-Curcumin in Juvenile Idiopathic Arthritis Evaluation of the Efficacy of Nanomicelle Curcumin Formulation in Children with Juvenile Idiopathic Arthritis(JIA) 2020-10-22 anticipated 40 Complete https://irct.ir/trial/50048 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: randomization method: Block randomization:This method is used to prevent significant imbalances in the number of participants assigned to each group. Block randomization ensures that no significant imbalance is established between groups at any time during randomization Randomization unit: individual Randomization tool: www.randomization.com website How to make a random sequence: For this method, the size of each block must first be specified (for example, a quadruple block). Then write a list of blocks and assign numbers to them (AABB (1) - ABAB (2) -ABBA (3) -BBAA (4) - BABA (5) - BAAB (6)) Then select random numbers between one and 6 (Eg 1 3 6, etc.) and finally specify the treatment allocation list based on previous random numbers (… AABB-ABBA-BAAB-) Allocation Concealment Method: Sealed Envelopes, Blinding description: The study is three-way blind in which the subjects, evaluators, analyzer, sample allocators will be unaware of the intervention and control groups. 2-3 Children with Juvenile Idiopathic Arthritis(JIA). Intervention 1: Intervention group: In the intervention group, patients with JIA will receive standard JIA treatment (according to the ACR 2019 Guideline) along with 40 mg daily curcumin syrup for 3 months. Intervention 2: Control group: In the control group, patients will receive standard treatment of JIA and the volume equivalent of placebo syrup daily for 3 months. Yes - There is a plan to make this available What will be shared: After the end of the study and data collection and data transfer to SPSS software, all patient data can be shared after unidentified individuals. When: Access period starts 6 months after the results are published To whom: Researchers working in academic, scientific and industrial institutes Conditions: No one is allowed to use the documents except the principal investigator. 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) All children between 6 and 16 years old referring to Akbar hospital Rheumatology subspecialty clinic who diagnosed suffering JIA according to ACR Guidline1 Obtain patient/patient's parents informed consent 6 years 16 years Both Children under 6 years old and or teenagers older than 16 years old Child with a history of underlying diseases including heart, kidney, liver, bile, digestive and or reumatoid ( any kind of reumatoid diseases except JIA) diseases simultaneous Consuming anticoagulant medicines like warfarin or anti-platelet medicines by patient Diabetic patients M08 Juvenile arthritis Treatment - Drugs Placebo Intervention group: In the intervention group, patients with JIA will receive standard JIA treatment (according to the ACR 2019 Guideline) along with 40 mg daily curcumin syrup for 3 months. Control group: In the control group, patients will receive standard treatment of JIA and the volume equivalent of placebo syrup daily for 3 months. In all patients, the severity of JIA disease will be assessed and recorded at baseline, at the end of the first month and at the end of the third month of treatment using the ACR-Pedi30 Score. The main factors examined in the ACR-Pedi30 Score are: 1- Physician evaluation of the disease activity (PhGA) 2- Evaluation of the patient or parents of the child from their child's health 3- Evaluation of joint function 4- Number of joints involved 5- Number of joints with limitations in Range of motion (ROM) 6- ESR measurement. Timepoint: At baseline, at the end of the first month and the end of the third month of treatment. Method of measurement: 1- Physician evaluation of the disease activity (PhGA) 2- Evaluation of the patient or parents of the child from their child's health 3- Evaluation of joint function 4- Number of joints involved 5- Number of joints with limitations in Range of motion (ROM) 6- ESR measurement. Mashhad University of Medical Sciences Approved 2019-12-07 Ethics committee of Mashhad University of Medical Sciences Razavi Khorasan Province, Mashhad, Daneshgah Avenue Mashhad Razavi Khorasan Iran (Islamic Republic of)