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IRCT20210815052186N1 IRCT 2021-09-05 Khoram-Abad University of Medical Sciences "The Effect of Garlic Extract on Lowering Blood Pressure in Prehypertensive Individuals" 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 2021-09-22 anticipated 110 Complete https://irct.ir/trial/58303 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: 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, Blinding description: 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. 3 Prehypertension. Intervention 1: Intervention group: The intervention group will receive a 500 mg capsule containing standardized garlic extract (allicin, The exact dose will be determined during the practical work), The study period will be eight weeks (56 days), the daily dose of the capsule for the intervention group is two per day. Intervention 2: Control group: The control or comparison group will receive a 500 mg capsule containing starch (containing 500 mg of starch).The study period will be eight weeks (56 days), the daily dose of the capsule for the control group is two per day. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is "There is no more information."
public Afshin Nazari
School of Medicine, Campus of Lorestan University of Medical Sciences, 4 km of Khorramabad-Borujerd road
Khorramabad Iran (Islamic Republic of) 6815144316 +98 66 3332 3704 nazary257@yahoo.com Khoram-Abad University of Medical Sciences scientific Elham Rahmatinia
School of Medicine, Campus of Lorestan University of Medical Sciences, 4 km of Khorramabad-Borujerd road
Khorramabad Iran (Islamic Republic of) 6815144316 +98 66 3332 3704 Elham_rahmatinia@ymail.com Khoram-Abad University of Medical Sciences Iran (Islamic Republic of) "People in Their 30s and 70s (Men and Women) Who Have Recently or At Least Three Months Received a Diagnosis of Pre-hypertension" 30 years 70 years Both People with Allergies to Garlic and its Side Effects People with Cardiovascular Problems and Diseases. Patients Who Have Previously been Diagnosed with High Blood Pressure and are Taking Antihypertensive Drugs. People with Diabetes. People who Have recently had surgery. People Who Have Recently Received Anesthetics. People with Blood Disorders Who are Taking Anticoagulants People with a History of Gallstones. People with a History of Hypoglycemia. Pregnant and Lactating Women I10 Essential (primary) hypertension Treatment - Drugs Placebo Intervention group: The intervention group will receive a 500 mg capsule containing standardized garlic extract (allicin, The exact dose will be determined during the practical work), The study period will be eight weeks (56 days), the daily dose of the capsule for the intervention group is two per day. Control group: The control or comparison group will receive a 500 mg capsule containing starch (containing 500 mg of starch).The study period will be eight weeks (56 days), the daily dose of the capsule for the control group is two per day. Blood pressure (Systolic, Diastolic, Pulse pressure, Mean arterial pressure). Timepoint: "Measurement of blood pressure at the beginning of the study (before the intervention) and 4 weeks after the intervention and at the end of the study (8 weeks after the start of the study)". Method of measurement: "Mercury Barometer". Nitric oxide metabolite level. Timepoint: Before the intervention, four weeks after the intervention, end of the intervention (eight weeks after the intervention). Method of measurement: Grace method. Triglyceride. Timepoint: Before the intervention, four weeks after the intervention, end of the intervention (eight weeks after the intervention). Method of measurement: Autoanalyzer device. Cholesterol. Timepoint: Before the intervention, four weeks after the intervention, end of the intervention (eight weeks after the intervention). Method of measurement: Autoanalyzer device. Low Density Lipoprotein (LDL). Timepoint: Before the intervention, four weeks after the intervention, end of the intervention (eight weeks after the intervention). Method of measurement: Autoanalyzer device. High Density Lipoprotein (HDL). Timepoint: Before the intervention, four weeks after the intervention, end of the intervention (eight weeks after the intervention). Method of measurement: Autoanalyzer. Khoram-Abad University of Medical Sciences Approved 2021-07-05 Ethics Committee of Lorestan University of Medical Sciences School of Medicine, Campus University of Medical Sciences, 4 km of Khorramabad-Borujerd road Khorramabad Lorestan Iran (Islamic Republic of)