Evaluation of the Efficacy of Nanomicelle Curcumin Formulation in Children with Juvenile Idiopathic Arthritis(JIA)
Design
A clinical trial with a control group, with parallel groups, triple blind, randomized, phase 3 on 40 patients, www.randomization.com was used for randomization.
Settings and conduct
In this study In addition to receiving standard treatment(based on the severity of the disease and according to the instructions of ACR Guidline1) (methotrexate), patients in the control group will be given a volume equivalent of placebo syrup and in the intervention group curcumin syrup at a dose of 40 mg/d for 2 months.
The study is performed in Akbar Children's Hospital in Mashhad
The study is three-way blind: the subjects, evaluators, analysts, sample allocators to the groups.
Participants/Inclusion and exclusion criteria
Entry conditions:
1- All children between 6 and 16 years old referred to Akbar hospital Rheumatology subspecialty clinic who diagnosed suffering JIA according to ACR Guidline1
2- Obtain patient/patient's parents informed consent
Non-entry conditions:
1- Children under 6 years old and or teenagers older than 18 years old
2- 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
3- Consuming anticoagulant medicines like warfarin or anti-platelet medicines by patient
4- Diabetic patients
Intervention groups
.. In all patients, illness severity will be evaluated(based on ACR-Pedi30 Score) at the beginning, after 1 and 3 months from the start of treatment. at the end of research, illness severity will be statistically compared between intervention and control group and also difference of responses will be evaluated based on gender.
Main outcome variables
check JIA Activity Index
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191221045837N1
Registration date:2020-09-28, 1399/07/07
Registration timing:prospective
Last update:2020-09-28, 1399/07/07
Update count:0
Registration date
2020-09-28, 1399/07/07
Registrant information
Name
Zinat Heidari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3180 1584
Email address
heidarizn@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-22, 1399/08/01
Expected recruitment end date
2022-10-23, 1401/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Efficacy of Nanomicelle Curcumin Formulation in Children with Juvenile Idiopathic Arthritis(JIA)
Public title
Effect of Nano-Curcumin in Juvenile Idiopathic Arthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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
Age
From 6 years old to 16 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Triple blinded
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.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
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.
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
Control group: In the control group, patients will receive standard treatment of JIA and the volume equivalent of placebo syrup daily for 3 months.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Akbar pediatric hospital
Full name of responsible person
Zinat Heidari
Street address
Akbar pediatric hospital, Shahid Kaveh Boulevard, Mashhad, Khorasan Razavi.