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IRCT20170820035796N2 IRCT 2019-01-08 Mazandaran University of Medical Sciences Evaluation of the effect of lemon balm plant on primary blood pressure control The explanation of the causes of high blood pressure and its therapies in Persian medicine and the effect of Lemongrass herbal product in primary blood pressure control 2018-10-23 anticipated 48 Complete https://irct.ir/trial/34125 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Crossover, Purpose: Treatment, Randomization description: The patients are categorized into two groups A and B by block randomizarion method.In the first four weeks, group A receives drug and group B placebo and after the washout period, group A receives placebo and group B drug. Unit of randomization is individual and samples are allocated by the software "random allocation". The samples are grouped in 12 blocks of 4, Blinding description: melitropic and placebo capsules with quite the same shape and color and weight will be produced and packaged in quite the same and will be one color and one shape.After the washout period, melitropic and placebo will be changed for each patient. A code will be randomly assigned to each box with the help of software. The expert will give it to the patient accidentally and without knowledge of the type of medicine. Thus the nature of each code will be unclear until the results are analyzed. The investigator, expert and patient will not be aware of the code in the container. 3 Hypertension. Intervention 1: Intervention group: Miliotropic capsule containing 400 mg of lemon balm daily three times a day for 4 weeks. Intervention 2: Control group: The capsule contains 400 mg of lactose daily three times a day for 4 weeks. 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 No more information.
public Seyde Sedighe Yousefi
Traditional and Complementary Medicine Reseach Centre, Khazar Blvd., Khazar square
Sari Iran (Islamic Republic of) 48168-95475 +98 11 3324 4893 z.shekarriz@mazums.ac.ir Mazandaran University of Medical Sciences scientific Seyde Sedighe Yousefi
Traditional and Complementary Medicine Reseach Centre, Khazar Blvd., Khazar square
Sari Iran (Islamic Republic of) 48168-95475 +98 11 3324 4893 s.yousefi@mazums.ac.ir Mazandaran University of Medical Sciences Iran (Islamic Republic of) Men and women 30-75 years old ُُSystolic blood pressure greater than or equal to 140, and diastolic blood pressure greater than or equal to 90 mmHg being treated with blood pressure medication (one to three drugs based on the protocol), but the patient’s blood pressure is uncontrolled At least one month has elapsed since the onset of drug use Have informed consent to participate in the study. 30 years 75 years Both Blood pressure equal to or greater than 110/180 at the start of the study or during intervention History of secondary hypertension Major symptoms of major organ damage (such as renal failure, congestive heart failure, myocardial infarction, or cerebrovascular accidents) During the 6 months before the study The presence of any type of cardiac arrhythmia (such as second- or third-degree blocks) Symptomatic valvular disease Liver dysfunction Type 1 and type 2 diabetic patients with impaired renal and liver function to the extent that clinically significant (ie more than 1.5 times the maximum normal creatinine and alanine aminotransferase more than 3 times the normal maximum) Low platelet count More than 100,000 per microliter of blood History of treated or untreated malignancies Potassium greater than 1.5 or less than 3.5 mg / L in the first visit History of hypothyroidism or hyperthyroidism Pregnancy and lactation The presence of any medical or surgical disorder that could interfere with the study. I10 Essential (primary) hypertension Treatment - Drugs Placebo Intervention group: Miliotropic capsule containing 400 mg of lemon balm daily three times a day for 4 weeks Control group: The capsule contains 400 mg of lactose daily three times a day for 4 weeks Blood pressure. Timepoint: In baseline and 5 times follow up measurement every 2 weeks. Method of measurement: Sphygmomanometer. Mazandaran University of Medical Sciences Approved 2018-09-26 Ethics committee of Mazandaran University of Medical Sciences Deputy of Research and Technology Mazandaran University of Medical Sciences, Moalem Ave., Moalem Square Sari Mazandaran Iran (Islamic Republic of)