Effect of Nano curcumin supplementation on the severity of diabetic sensorimotor polyneuropathy in type 2 diabetic patients : a double- blind randomized clinical trial

Determination of the Effect of Nanocorcumin Supplementation Compared to Placebo on the severity of diabetic sensorimotor polyneuropathy in type 2 diabetic patients.

This study is conducted on 80 patients with diabetic polyneuropathy who have been admitted to the Diabetes Research Center.Patients are randomly divided into two groups: intervention and control groups and each participant is allocated a code.

This study is a double-blind, randomized, clinical trial on diabetic patients with neuropathy in Diabetic Research Center of Kermanshah University of Medical Sciences.Patients will be randomized into two groups of supplementation with curcumin and placebo for 8 weeks. Curcumin supplements are provided in the form of 80 mg capsules. A supplement will be consumed daily in the form of a capsules .Consuming supplement has been followed up in person every month .Meanwhile, once a week, the use of supplements is followed up by phone call.At the beginning and end of the study, from each person will taken two 24-hour meal reminders , and physical activity will be reviewed using the International Short Form Physical Activity Questionnaire (IPAQ).To determine the severity of neuropathy, the Toronto questionnaire will be used. Anthropometric evaluations are also performed. The study will be double blind, and the researcher and the patient will not get any supplementation information.

In this study, non-insulin type 2 diabetic patients with mild diabetic sensorimotor polyneuropathy will be included. People with other illnesses or those with neuropathies other than diabetic polyneuropathy will not be included in the study.

Receiving nano-curcumin supplements formed of nanomixel curcumin particles, an effective ingredient in turmeric, by the intervention group and receiving placebo formed of all formulations of the drug except of curcumin , by the control group in the form of gel capsules of 80 milligrams from the Minoo Pharmaceutical Company Are being prepared. A 80 mg supplement will be consumed daily as a lunch capsule.

Severity of sensory-motor movement polyneuropathy; Blood pressure levels of fasting blood glucose, HbA1C and BS2hpg

For random allocation of individuals by statistic expert, permute-block randomization will be used for the two groups of study; thus, four blocks of AABB, ABAB, ABBA, BBAA, BABA, and BAAB are selected 20 times randomly and with placement, and The letters of the selected blocks will be written after each other. Stratified randomization will be used to control age and gender variables, based on the following categories: age (30-45, 46-60) and gender (male, female).

The researcher and the patient do not have any information on the type of supplement that they receive and they are prepared in the same way as in the form of tablets and supplements like nano-curcumin. A person who is not aware of the packet content will be asked to complete the naming of the supplement and the placebo in groups A and B. After collecting data at the end of the study, the codes of supplements will be specified for the researchers