Evaluation of the Urtica Dioica effect on blood glucose parameters and lipidprofile in patients with type 2 diabetes: a randomized double-blind clinical trial

The effect of nettle plant on blood glucose parameters and lipid profiles of patients with type 2 diabetes: a double-blind clinical trial

A clinical trial with a control group, with a parallel group, random block and double-blind, will be conducted on 106 patients, each group consisting of 53 people.In order to randomly assign people to two groups and ensure the balance of the number of people in the groups, the block randomization method will be used. In this study, blocks with sizes of four will be created and randomly half of The people of each block will be placed in one group and half in another group SPSS 23 software will be used for data analysis.

Patients with type 2 diabetes will be from the clinics affiliated to the Endocrine and Metabolism Research Institute of Tehran University. The study sample will be allocated randomly and by random block method to two groups: 1- receiving the medicine 2- receiving placebo and study conducts for three months. The trial group receive 25 mg medicine every 12 hours

Inclusion: having type 2 diabetes, taking oral hypoglycemic drugs, aged 30 to 65 years Failure to enter: having type 1 diabetes, in case of insulin therapy during the last three months, and other specific types of diabetes

The criteria of response to treatment, including fasting and two-hour blood sugar reduction, will be evaluated in both the intervention and placebo groups. By following up the condition of the patients for 3 months after the start of the treatment, the improvement in the control of blood sugar levels in the patients between the two intervention and placebo groups will be evaluated.

FBS BP HbA1C level Anthropoid metric criteria Kidney function Liver function Inflammatory factors Serum insulin

Correction of information related to sampling time

In order to randomly assign people to two groups and ensure the balance of the number of people in the groups, the block randomization method will be used. In this study, blocks with sizes of four will be created and randomly half of The people of each block will be placed in one group and half in another group It is possible that half of the people will be assigned to group A (drug receiving group) and the other half will be assigned to group B (control group): 1-BAAB-6 ABBA-5 BABA-4 ABAB-3 BBAA-2 AABB Then, one of the numbers 1 to 6 will be assigned to each of the blocks of 4, and from blocks 1 to 6, simple random combinations (blocks) are made using the table of random numbers. Selection of blocks will continue until the division of 106 patients into two groups of 53 intervention and control. The selected blocks are written in a consecutive sequence and according to this sequence, the people included in the study will be assigned to one of two groups A or B. First sequence The results obtained are recorded using the block randomization method and a number from 1 to 106 will be assigned to each of the letters A and B in the created sequence, which indicates receiving the drug. Due to the unpredictability of the sequence created by the block randomization method, all researchers except the main researcher will remain unaware of the size and order of the blocks.

Conducting this research is such that neither patients nor clinical caregivers know information that may affect the results. After giving the patient's number, the clinical caregivers deliver the package prepared for his number to the patient without knowing its content, and the patient does not know whether the delivered package is a medicine or a placebo. The packages have already been prepared by the researcher. and numbered.