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IRCT20230612058459N1 IRCT 2023-06-27 Rafsanjan University of Medical Sciences The effect of achillea millefolium on blood inflammatory factors in patients with type 2 diabetes Investigation the effect of achillea millefolium oral supplement on some biochemical and inflammatory blood factors in patients with type 2 diabetes referred to Rafsanjan diabetes clinic, in 2023 2023-07-11 anticipated 31 Complete https://irct.ir/trial/70633 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Random classification by minimization method: In this method, classes are first formed based on the important variables desired by the researcher, which in this study are blood tests, then among the patients who meet the entry criteria, the first samples are randomly selected (on based on lion and line) are included in the study and are placed in one of the groups. For the following examples, the sum of the indicators in two groups is given attention and the sample is assigned to the group that has a lower sum, Blinding description: Drugs and placebo are similar in shape, packaging, color and smell. In order to blind patients, the pharmacist is asked to identify the drug and the placebo with numbers one and two so that the researcher does not know about the content of the capsules (drug or placebo). Patients are also given the capsules numbered 1 and 2 and the patient also doesn't know about the content of the capsules. The blinding will also be available for the analyzer, and after completing the analysis, the pharmacist will be asked to disclose the content of the capsules. 2-3 diabetes. Intervention 1: Intervention group: In this group, patients receive a 500 mg capsule of achillea millefolium (made by Rafsanjan Asans Daru company) daily for 12 weeks. Intervention 2: Control group: In this group, patients will receive placebo (a 500 mg capsule of cellulose, made by Rafsanjan Asans Daru company ) daily for 12 weeks. 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 Respecting the rights of patients
public Vahid mohammadi shahrokhi
Faculty of Medicine, Rafsanjan University of Medical Sciences
Rafsanjan Iran (Islamic Republic of) 7717933777 +98 34 3428 0038 v_md_sh@yahoo.com Rafsanjan University of Medical Sciences scientific Vahid Mohammadi shahrokhi
Faculty of Medicine, Rafsanjan University of Medical Sciences
Rafsanjan Iran (Islamic Republic of) 7717933777 +98 34 3428 0038 v_md_sh@yahoo.com Rafsanjan University of Medical Sciences Iran (Islamic Republic of) Having type II diabetes Age over 40 years old Inform consent for participate in the study History of diabetes for at least five years 40 years no limit Both Participate in another research project Having other physical illnesses in addition to diabetes Pregnancy and lactation Allergy to medicinal plants E08.40 Diabetes mellitus due to underlying condition with diabetic neuropathy, unspecified Treatment - Other Treatment - Other Intervention group: In this group, patients receive a 500 mg capsule of achillea millefolium (made by Rafsanjan Asans Daru company) daily for 12 weeks. Control group: In this group, patients will receive placebo (a 500 mg capsule of cellulose, made by Rafsanjan Asans Daru company ) daily for 12 weeks Mean blood inflammatory factors. Timepoint: At the beginning of the study (before the intervention) and 12 weeks after the intervention. Method of measurement: Biochemical autoanalyzer. Liver enzymes. Timepoint: At the beginning of the study (before the intervention) and 12 weeks after the intervention. Method of measurement: Biochemical autoanalyzer. Michigan neuropathy questionnaire. Timepoint: At the beginning of the study (before the intervention) and 12 weeks after the intervention. Method of measurement: questionnaire. Rafsanjan University of Medical Sciences Approved 2023-05-31 Ethics Committee of Rafsanjan University of Medical Sciences Central office of Rafsanjan University of Medical Sciences (RUMS), Imam Ali Blvd, Ali Ibn Abitaleb square Rafsanjan Kerman Iran (Islamic Republic of)