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IRCT20150713023190N13 IRCT 2022-05-24 Rafsanjan University of Medical Sciences The effect of achillea millefolium on HbA1C and peripheral neuropathy in diabetic patients Investigating the effect of oral supplement of achillea millefolium on HbA1C and peripheral neuropathy in type 2 diabetic patients 2022-06-05 anticipated 70 Complete https://irct.ir/trial/63468 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Stratified randomization by minimization method: in this method, initially, the patients will categorize based on key variables, such as Michigan neuropathy questionnaire score and HbA1C variables. Afterwards, from the patients who will meet the inclusion criteria, the first participant will place in the intervention or control group by coin flip, and other participants will allocate to the study group with lower total of variables, 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 Confidentiality of data
public Tabandeh Sadeghi
Nursing and midwifery school, Parastar Ave
Rafsanjan Iran (Islamic Republic of) 7718796755 +98 34 3425 5900 t.b_sadeghi@yahoo.com Rafsanjan University of Medical Sciences scientific Tabandeh Sadeghi
Nursing and midwifery school, Parastar Ave
Rafsanjan Iran (Islamic Republic of) 7718796755 +98 34 3425 5900 t.b_sadeghi@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 Getting a score above 7 from the Michigan neuropathy questionnaire 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 Having psychiatric diseases Pregnancy Lactation History of hereditary neuropathies or underlying diseases that cause neuropathy such as chronic uremia Autoimmune diseases (rheumatism, multiple sclerosis, osteoarthritis) Allergy to medicinal plants Wounds or infections on the feet Lower extremity amputation Use of anticoagulant drugs E08.40 Diabetes mellitus due to underlying condition with diabetic neuropathy, unspecified Treatment - Other Placebo 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 of HBA1C. Timepoint: At the beginning of the study (before the intervention) and 12 weeks after the intervention. Method of measurement: Spectrophotometer device. Peripheral neuropathy score. Timepoint: At the beginning of the study (before the intervention) and 12 weeks after the intervention. Method of measurement: Michigan neuropathy questionnaire. Rafsanjan University of Medical Sciences Approved 2022-04-13 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)