Investigating the effect of extract of rosa canina fruit on orthostatic hypotension in people with type 2 diabetes

Determining the effectiveness of Nestern on orthostatic hypotension in people with type 2 diabetes

A clinical trial with a control group, double-blind, randomized, phase 3 on 60 patients. For randomization, simple randomization method is used through Random allocation software version 2.0.

This study will be conducted in Yazd diabetes center on patients with type 2 diabetes and orthostatic hypotension. One group will receive placebo and one group will receive capsules containing Rosa canola plant extract based on the random allocation list prepared by the statistician. Drug and placebo are marked in similar packages with letters A and B, and only the pharmaceutical company knows which package is drug or placebo, and the researcher, statistical consultant, patients, and supervisor do not know about this.

Inclusion criteria: age over 18 years; suffering from type 2 diabetes; Suffering from orthostatic hypotension based on internal specialist's diagnosis. Exclusion criteria: recent stroke or heart attack, having heart rhythm disorders, uncontrolled blood pressure, end-stage renal disease (ESRD), neuromuscular disease, heart failure (CHF), HA1C level more than 9, GFR level less than 30, people who are treated with prazosin and tamsulosin, unwillingness to treatment

People with type 2 diabetes who have orthostatic hypotension

Improvement of orthostatic hypotension in patients with type 2 diabetes

In this study, one of the groups is denoted by the letter A and the other group by the letter B. Then, the random allocation list is prepared by using the simple randomization method and through the Random allocation software version 2.0 by the statistical consultant. In this way, it is determined which of the types of drug packages each patient will receive based on the order of entry into the study(A or B). The drug and placebo are packed in similar containers by the drug supplier and labeled with the letters A and B. Which letter indicates which intervention is determined by the drug supplier during labeling, and Until the completion of the study, no one other than her/him will be informed about this issue.

Patient: Capsules containing medicine and placebo are completely similar in terms of shape, color and packaging. Due to the fact that rosa canina has a pleasant smell and the drug and placebo can be distinguished by the smell, so somerosa canina essential oil will be added to the content of the placebo so that they are almost similar in smell. Principal Investigator: The concerned resident will receive identical sealed medication packages marked with the letter A or B and will not be informed of which drug/placebo is contained in each medication package. Statistical consultant: She prepares the randomization list for two letters A and B, but she will not know which letter represents the intervention and which represents the control.