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IRCT20220516054879N3 IRCT 2022-12-25 Rasht University of Medical Sciences effect of nettle extract on insulin resistance Evaluation of the effect of nettle (urtica dioica) extract on medical parameters and insulin resistance in pediatric patients with obesity 2022-12-22 anticipated 64 Complete https://irct.ir/trial/67416 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Type of randomization, details of any restrictions (such as blocking and block size): Permuted block randomization method of 4 is used to randomize people in two groups. Considering that group A is the intervention group and group B is the control group.The randomization process will be as follows. The entire randomization file is available as an Excel file (randomization was done with SAS software version 9) The method used to generate a random allocation sequence by mentioning the name of the software or site used: Randomization was done with SAS software version 9 Allocation concealment method: Group assignment will be done through closed envelopes. Randomization implementation process: The randomization process will be carried out under the supervision of the project manager and by him and with the direct supervision of the statistician and the supervisor, Blinding description: Since it is not possible to make a placebo for us due to the taste and smell of the product; One group of patients receives nettle syrup in addition to following the diet, and in the other group, only the diet is controlled.Therefore, the patients are not blinded to the treatment group, and they are only researchers and statistical experts analyzing the information blinded to the treatment group. 2-3 Insulin resistance - obesity - children. Intervention 1: Intervention group: In addition to following the diet, nettle syrup (hydroalcoholic extract) of Zarband company is received in the form of 5 cc twice a day for 12 weeks. Intervention 2: Control group: the diet alone is observed for 12 weeks. No - There is not a plan to make this available Justification or reason for not sharing IPD is Preservation of patients' privacy and compliance with ethical principles
public Maryam Shahrokhi
Rasht - Namjo Street - Shahid Siyadati Street - 17 Shahrivar Hospital
Rasht Iran (Islamic Republic of) 414465379 0098133369019 shahrokhi.mail85@gmail.com Rasht University of Medical Sciences scientific Maryam Shahrokhi
Rasht - Namjo Street - Shahid Siyadati Street - 17 Shahrivar Hospital
Rasht Iran (Islamic Republic of) 4144654379 +98 13 3336 9019 shahrokhi.mail85@gmail.com Rasht University of Medical Sciences Iran (Islamic Republic of) Children 12 to 18 years old BMI greater than 85th percentile for age and sex Allergy to nettle and its products (if exposed and reported by the patient) Not suffering from hypotension (lower blood pressure less than 90 on 60 mm Hg) Absence of heart and kidney failure (according to medical examinations and laboratory results) 12 years 18 years Both patient reluctance to participate in the study, Patient taking lithium, warfarin and antihypertensive drugs, Fluid retention due to reduced heart and kidney function E66 Overweight and obesity Treatment - Other Lifestyle Intervention group: In addition to following the diet, nettle syrup (hydroalcoholic extract) of Zarband company is received in the form of 5 cc twice a day for 12 weeks. Control group: the diet alone is observed for 12 weeks Fasting blood suger. Timepoint: month 0, 1, 3. Method of measurement: blood test. Fasting insulin levels. Timepoint: month 0, 1, 3. Method of measurement: blood test. Homa insulin resistance factor. Timepoint: month 0, 1, 3. Method of measurement: blood test. Rasht University of Medical Sciences Approved 2022-12-07 Ethics Committee of Gilan University of Medical Sciences Rasht-Namjo Street-Shahid Siadati Street-in front of 17 Shahrivar Hospital-Deputy for Research and Technology Rasht Guilan Iran (Islamic Republic of)