Investigating the effect of oral supplement of achillea millefolium on HbA1C and peripheral neuropathy in type 2 diabetic patients

Determination the effect of oral supplement of achillea millefolium on HbA1C and peripheral neuropathy in type 2 diabetic patients

A double blinded, randomized, controlled clinical trial with a parallel group design

In this randomized double blind clinical trial, the research population are patients with type 2 diabetes who will referred to the Diabetes Clinic in Rafsanjan. These patients will selected by convenient sampling method and will be assigned to intervention and control groups using minimization methods. The intervention group will receive achillea millefolium for 12 weeks. In the control group, the patients will receive cellulose as a placebo similar to those in the intervention group.

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 and history of diabetes for at least five years are inclusion criteria. 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 and use of anticoagulant drugs are exclusion criteria.

Intervention group: In this group, patients receive a 500 mg capsule of achillea millefolium, made by Rafsanajn Asans Daru Company, daily for 12 weeks. Control group: In this group, patients will receive placebo (a 500 mg capsule of cellulose, made by Rafsanajn Asans Daru Company), daily for 12 weeks.

Peripheral neuropathy, HbA1C

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.

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.