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IRCT20210906052392N1 IRCT 2021-10-20 Esfahan University of Medical Sciences Study of the effects of Salvadora persica extract on blood sugar and lipid profile in diabetic patients (type2) Study of the effects of Salvadora persica extract on blood sugar and lipid profile in diabetic patients (type2) 2021-10-08 anticipated 120 Complete https://irct.ir/trial/58552 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Sampling is done by easy sampling method. In this study, random allocation will be done by Stratified Permuted Blocked Randomization (by age-sex subgroups). In this method, eligible individuals with inclusion criteria will be selected and then they will be randomly divided into three groups of interventions and controls using three blocks. Finally, a table with 4 columns for men over 50, men under 50, women over 50, women under 50, each column in the rows containing the letters A, B, C randomly for three study groups. At the beginning of the patients' arrival, if the entry conditions are met, according to their age and gender, it is placed in a column and according to the English letters, it is placed in one of the study groups, Blinding description: In this study, neither the patient nor the researcher nor the analyzer knew in which intervention group or placebo. Patients are divided into three groups A, B, C. Drugs are also in three categories A, B, C that are assigned to patients. The analyzer does not know which group of patients will receive medication or placebo until the end of the analysis of the results. 2-3 Diabetes melitus type 2. Intervention 1: Intervention group: Group 1: Consumption of medicine for 8 weeks, syrup containing S. persica extract in a dose of 150 mg twice a day. Intervention 2: Intervention group: Group 2: Consumption of medicine for 8 weeks, syrup containing S. persica extract in a dose of 300 mg twice a day. Intervention 3: Control group: Take a placebo for 8 weeks, a syrup containing the same inactive substance twice a day. No - There is not a plan to make this available Justification or reason for not sharing IPD is Data confidentiality
public Akram Izadikhah
Soroush St. Mosalla St.
Isfahan Iran (Islamic Republic of) 8198674531 +98 31 3448 4777 a.izadikhah@resident.mui.ac.ir Esfahan University of Medical Sciences scientific Akram Izadikhah
Mosalla Street
Isfahan Iran (Islamic Republic of) 8198674531 +98 31 3448 4777 a.izadikhah@resident.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Having type 2 diabetes in the last 10 years Age 60-30 years HbA1c between 5.6 to 7.5 Patient consent to participate in the project 35 years 70 years Both Pregnancy or breastfeeding Use of injectable hypoglycemic drugs (injectable insulin) and oral sulfonylureas Renal or liver failure Treatment - Drugs Treatment - Drugs Placebo Intervention group: Group 1: Consumption of medicine for 8 weeks, syrup containing S. persica extract in a dose of 150 mg twice a day Intervention group: Group 2: Consumption of medicine for 8 weeks, syrup containing S. persica extract in a dose of 300 mg twice a day Control group: Take a placebo for 8 weeks, a syrup containing the same inactive substance twice a day Fasting blood sugar. Timepoint: Before the start of the study, the end of 8 weeks of intervention. Method of measurement: medical lab. Triglyceride, Cholesterol, HDL. Timepoint: Before the start of the study, the end of 8 weeks of intervention. Method of measurement: medical lab. Homa IR. Timepoint: Before the start of the study, the end of 8 weeks of intervention. Method of measurement: medical lab. AST, ALT. Timepoint: Before the start of the study, the end of 8 weeks of intervention. Method of measurement: medical lab. HbA1c. Timepoint: Before the start of the study, the end of 8 weeks of intervention. Method of measurement: medical lab. BMI. Timepoint: Before the start of the study, the end of 8 weeks of intervention. Method of measurement: medical lab. Constipation score. Timepoint: Before the start of the study, the end of 8 weeks of intervention. Method of measurement: Using the WEXNER questionnaire. Gastrointestinal symptoms score. Timepoint: Before the start of the study, the end of 8 weeks of intervention. Method of measurement: Researcher-made gastrointestinal symptoms questionnaire. Urinary symptoms score. Timepoint: Before the start of the study, the end of 8 weeks of intervention. Method of measurement: Researcher-made questionnaire on urinary symptoms. Score of skin symptoms. Timepoint: Before the start of the study, the end of 8 weeks of intervention. Method of measurement: Researcher-made skin symptoms questionnaire. Nervous Symptoms Score. Timepoint: Before the start of the study, the end of 8 weeks of intervention. Method of measurement: Researcher-made neurological symptoms questionnaire. Esfahan University of Medical Sciences Approved 2021-09-14 Research Ethics Committee Isfahan University of Medical Sciences, School of Medicine Hezar Jerib Street Isfahan Isfehan Iran (Islamic Republic of)