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IRCT20220516054879N2 IRCT 2022-07-06 Rasht University of Medical Sciences Evaluation of the effect of extract of nettle (Urtica Dioica) on blood glucose in adolescent patients with type 1 diabetes , A Randomized Double Blinded Controlled Trial Evaluation of the effect of extract of nettle (Urtica Dioica) on blood glucose in adolescent patients with type 1 diabetes , A Randomized Double Blinded Controlled Trial 2022-07-23 anticipated 50 Complete https://irct.ir/trial/63748 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization type, details of any restrictions (such as blocking and block size): Due to the equality and lack of diagnosis of the type of treatment by the participants, the block randomization method will be used. According to the number of sample sizes, the size of the blocks is 4. The method used to generate a random allocation sequence using the name of the software or site used: Random blocking will be assigned to research units in numbers 1 to 30, respectively. Then a table with 6 rows called blocks and each block will have 5 sections and each section will be named with A and B, will be considered. In the next step, the numbers are placed in each house in order. After all the numbers are placed in the blocks, the people who had the number in house A will receive the intervention medicine and the people who had the number in house B will be considered as the control group. The website https://www.sealedenvelope.com is used for randomization. Allocation Concealment method: The numbered Sequentially Envelopes: sealed, opaque envelopes method is used to hide random allocation. Randomization process (who will determine the random allocation sequence, who will register participants, who will assign participants to interventions): The randomization process will be performed under the supervision of the project manager and by him and with the direct supervision of a statistician and the supervisor, Blinding description: the investigator and data analyzer were blinded. 2-3 Type 1 diabetes - insulin - children. Intervention 1: Intervention group received insulin with 5 cc of zardband company nettle syrup (Hydroalcoholic extract) twice a day for 12 weeks. Intervention 2: Control group received routine insulin. No - There is not a plan to make this available Justification or reason for not sharing IPD is Patient privacy and ethical principles
public Maryam Shahrokhi
17shahrivar Hospital-Shahid Siadati Street-Namjoo Street-Rasht
Rasht Iran (Islamic Republic of) 414465379 +98 13 3336 9019 shahrokhi.mail85@gmail.com Rasht University of Medical Sciences scientific Maryam Shahrokhi
17shahrivar Hospital-Shahid Siadati Street-Namjoo Street- Rasht
Rasht Iran (Islamic Republic of) 4144654379 +98 13 3336 9019 shahrokhi.mail85@gmail.com Rasht University of Medical Sciences Iran (Islamic Republic of) 12-18 years old Patients with type 1 diabetes treated with insulin and with improper blood sugar control (A1C greater than 6.5 mg / dl) provided that their BUN and serum creatinine are satisfactory and the patient does not classified as a patient with renal impairment.(BUN 8-20 mg / dL and creatinine less than 1.5 mg / dL.) 12 years 18 years Both Patient reluctance Patient taking lithium, warfarin and antihypertensive drugs Due to the existence of drug interactions according to the WHO source History of previous allergies to nettle edible products Change of more than 0.3 units in the parameters of patient's renal function E10 Insulin-dependent diabetes mellitus Treatment - Other N/A Intervention group received insulin with 5 cc of zardband company nettle syrup (Hydroalcoholic extract) twice a day for 12 weeks. Control group received routine insulin Fasting blood glucose sugar reduction. Timepoint: The variable will be measured at the beginning of the study, 4, 8 and 12 weeks after the start of the study. Method of measurement: Home glucose testing devices or blood tests. A1C reduction. Timepoint: This variable will be measured at the beginning of the study and 12 weeks after the start of the study. Method of measurement: blood test. Insulin dose reduction. Timepoint: This variable will be measured at the beginning of the study and 12 weeks after the start of the study. Method of measurement: blood test. Rasht University of Medical Sciences Approved 2022-06-01 ethics committee of guilan university of medical sciences Dputy of research and technology, In front of 17 shahrivar hospital, Shaid siadati street,Namjoo street, Rasht Rasht Guilan Iran (Islamic Republic of)