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IRCT20190112042332N1 IRCT 2019-01-26 Bagheiat-allah University of Medical Sciences Effect of Fenugreek, Cranberries, Chicory and Nettle seed extracts on blood glucose in type 2 diabetic patients Effect of Fenugreek, Cranberries, Chicory and Nettle seed extract on blood glucose in type 2 diabetic patients 2017-09-23 anticipated 100 Complete https://irct.ir/trial/36773 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Treatment assignment is randomly assigned, in a 1:1 ratio, at each site using a block size of 6. Herbal and placebo medicines are packed in packages that are quite similar to those labeled A and B.To select patients, each patient should first receive a number from 1 to 100 (total sample size) given randomized visits to patients from closed medicines, Blinding description: The treatment assignments are known to the study coordinator. Participants, treating clinicians, and outcome assessors are blinded to intervention group status. N/A Blood Glucose Control in Type 2 Diabetic patients. Intervention 1: Intervention group: Two Capsule containing one fourth of the effective dose of four medicinal herbs. Intervention 2: Control group: Two Capsule containing Rye bread powder, 1000 mg twice a day, morning and night after meals. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Khalil Mohamadzadeh
Baqiyatallah Hospital, Mullasadra Street, Vanak Square, Tehran
Tehran Iran (Islamic Republic of) 1435915371 +98 21 8805 0436 stu.khalil.mhmd@bmsu.ac.ir Bagheiat-allah University of Medical Sciences scientific Nahid Khalili
Baqiyatallah University of Medical sciences, Mullasadra Street, Vanak Square, Tehran
Tehran Iran (Islamic Republic of) 141556437 +98 21 8805 0436 stu.khalil.mhmd@bmsu.ac.ir Bagheiat-allah University of Medical Sciences Iran (Islamic Republic of) Male and female subjects between 20 and 70 years of age Noninsulin-dependent diabetes minimum of 2 years before the study enrollment Patients with diabetes Type 2 and on any antidiabetic medication (oral hypoglycemic agent, insulin) Patients willing to give informed consent Patients with out other comorbid conditions (cardiac, renal, macrovascular and microvascular complication) Non Gangren's diabetic foot ulcer Not Currently pregnant or breastfeeding, fertile women with out using any contraceptives methods Current daily tobacco smoker and Alcohol consumption with out any decision to change diet and physical style Not having a history of cancer less than 5 years and a depression 20 years 70 years Both Evidence of any unwanted side effects of the drug include increased liver enzymes or functional renal dysfunction or Lower blood glucose control in the requested serial tests Evidence of any unwanted gastrointestinal discomfort, such as diarrhea, nausea, or gastrointestinal intolerance of the combined medication Any unwillingness of participants to continue to participate in the plan E11 Type 2 diabetes mellitus Treatment - Drugs Placebo Intervention group: Two Capsule containing one fourth of the effective dose of four medicinal herbs Control group: Two Capsule containing Rye bread powder, 1000 mg twice a day, morning and night after meals Fasting Blood Glucose. Timepoint: Before, at the first of study, daily for 3 days, once 2days for 4 days , on the days of 15, 30, 45 and 60. Method of measurement: patients with check fasting blood glucose with Glucometer at Home. Liver Function Test. Timepoint: Before, After, At the end of first month, At the end of second month. Method of measurement: Liver Function Tests. Bagheiat-allah University of Medical Sciences Approved 2017-10-29 Research Ethics Committee of Baqiyatallah University of Medical Sciences Baqiyatallah University of Medical Sciences, Mullasadra Street,Vanak Square,Tehran Tehran Tehran Iran (Islamic Republic of)