The Effects of Garlic Extract(Dosage Form) on Blood Pressure in Pre-Hypertensive Individuals and Measuring Lipid Profiles and Nitric Oxide Metabolites in the Individuals

The aim of this study was to investigate the effect of garlic extract (dosage form) on blood pressure in prehypertensive individuals and to measure lipid profiles and nitric oxide metabolites in these individuals.

Two arm parallel group randomised, double blinded, sham controlled clinical trial with 110 patients.

This double-blind randomized clinical trial (RCT) study was performed on pre-hypertensive individuals referred to Khorramabad Health Center in 1400. The study lasts for eight weeks. During this period, individuals in the treatment group will receive two capsules daily at a dose of 500 mg and individuals in the placebo group will receive two placebo capsules daily. Variables are measured once at the beginning of the study, once at the end of the fourth week and again at the end of the study. The individuals (both in the treatment group and the control group) will receive the drug in sealed envelopes that are coded. Coding is done by the design partner. The researcher as well as the volunteers do not know the contents of the envelopes, in other words, they are blind.

"People in their 30s and 70s (men and women) who have recently or at least three months been diagnosed with prehypertension" will be included in the study. People with sensitivity to garlic and its side effects; people with cardiovascular problems and diseases; Hypertensive patients; Diabetic patients; people who have recently had surgery or received anesthesia; people with blood disorders who are taking anticoagulants; people with a history of gallstones and history of hypoglycemia; and pregnant women and breastfeeding will not be included in this study.

Treatment group: Recipient of 500 mg garlic capsule Control group: Recipient of 500 mg placebo capsule

Blood pressure, Lipid profiles, Nitric oxide

In order to equalize the distribution of two important confounders of age and sex, classes based on these two variables are created as "age group 30 to 50 years / age group 50 to 70 years" and "men / women" and then randomly Block Randomization is divided into two groups of treatment and control. The size of each block is 4 items, so that 6 different combinations of 4 blocks are created and are selected randomly by placing the blocks. Using this method, the sample size in the two study arms will be equal (balance) and the difference between the two groups in terms of sample size will be a maximum of half a block (two people). Using this method of random allocation, maximum power can be expected in the study results.All tests will be performed using stata14 software.

In this study, volunteers receiving medication are blind to the study. Also, the main researcher who has other roles such as patient care, data collection and analysis, and evaluation of outcomes is blind to the study.The patient will receive the drug (intervention or control) in sealed envelopes that are coded. Coding is done by the design partner and the researcher (who also has other roles) as well as the patient in relation to the contents of the envelope, They are blind.