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IRCT20120215009014N229 IRCT 2018-08-22 Hamedan University of Medical Sciences Anti-diabetic effect of herbal formulation versus placebo in diabetic patients Anti-diabetic effect of herbal formulation versus placebo in diabetic patients: a triple-blind randomized clinical trial 2018-09-23 anticipated 58 Complete https://irct.ir/trial/33050 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The patients will be randomly assigned to intervention and control groups using block randomization, Blinding description: Patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. The analyzer will be unaware of the type of interventions Therefore, the trial will be run as triple blind. 2 Diabetes mellitus. Intervention 1: Intervention group: Routine treatment of diabetes plus herbal formulation capsule 100 mg daily for 3 months. Intervention 2: Control group: Routine treatment of diabetes plus placebo capsule daily for 3 months. 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 It depends on the situations and the results of the study as well as approval of the financial supporting organization.
public Mohammad Amin Shakeri Rad
School of Pharmacy, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
Hamadan Iran (Islamic Republic of) 6517838695 +98 81 3838 0572 shakeri.amin.kourosh@gmail.com Hamedan University of Medical Sciences scientific Dr. Dara Dastan
School of Pharmacy, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
Hamadan Iran (Islamic Republic of) 6517838695 +98 81 3838 0572 d.dastan@umsha.ac.ir Hamedan University of Medical Sciences Iran (Islamic Republic of) Age of 30 to 60 years; Type 2 diabetes; Hemoglobin A1c above 7% 30 years 60 years Both Renal disorder; Liver disorder; Gastric disorder; Cardiovascular diseases E08 Diabetes mellitus due to underlying condition Treatment - Drugs Placebo Intervention group: Routine treatment of diabetes plus herbal formulation capsule 100 mg daily for 3 months Control group: Routine treatment of diabetes plus placebo capsule daily for 3 months Measuring fasting blood sugar. Timepoint: Before intervention and 3 and 6 months after intervention. Method of measurement: By laboratory test. Measuring blood sugar. Timepoint: Before intervention and 3 and 6 months after intervention. Method of measurement: By laboratory test. Measuring hemoglobin A1c. Timepoint: Before intervention and 3 and 6 months after intervention. Method of measurement: By laboratory test. Hamedan University of Medical Sciences Approved 2018-07-21 Ethics Committee of Hamadan University of Medical Sciences Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave Hamadan Hamadan Iran (Islamic Republic of)