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IRCT20140519017756N34 IRCT 2018-01-30 Iran University of Medical Sciences Impact of mao’ljabn or cheese-water on primary hypertension A clinical trial comparing the effects of placebo and the Iranian traditional medicinal product of mao’ljabn or cheese-water on primary hypertension 2017-11-22 anticipated 112 Complete https://irct.ir/trial/29170 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants are allocated into study groups via simple random allocation, Blinding description: The participants are explained about the study objectives and procedures. Nonetheless, neither the patients nor the researchers know who has received the experimental drug. 2 hypertension. Intervention 1: Intervention Group (cheese-water): 50 grams of cheese-water powder dissolved in bristled water consumed twice daily before meals in the morning and evening for 6 weeks. Intervention 2: Control Group (maltodextrin): 50 grams of maltodextrin powder diluted in bristled water consumed twice daily before meals in the morning and evening for 6 weeks. Yes - There is a plan to make this available What will be shared: Deidentified Individual Participant Data Set can be provided to other researchers. When: after the study report is published as a paper and for 2 years since the paper is published To whom: researchers who ask for it Conditions: no certain criteria Where to obtain: the personal email of researchers How to obtain: personal correspondence Comments:
public Dr Maryam Navabzadeh
Ghaffari St.
Birjand Iran (Islamic Republic of) 9717853577 +98 56 3239 5000 mnavab94@gmail.com Iran University of Medical Sciences scientific Dr Maryam Navabzadeh
Ghaffari St.
Birjand Iran (Islamic Republic of) 9717853577 +98 56 3239 5000 mnavab94@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Being in stage 1 hypertension (i.e., systolic blood pressure greater than or equal to 140, and diastolic blood pressure greater than or equal to 90 mmHg based on the new definition of the Joint National Committee-8 Being treated with blood pressure medication (one to a maximum of three drugs based on the protocol), but the patient’s blood pressure is uncontrolled and still in stage 1 hypertension A minimum of one month passed from the onset of drug consumption Body mass index below 30 Age between 18 and 80 years 18 years 80 years Both Stage 2 or above according to hypertension classification of the Joint National Committee-VIII Blood pressure greater than or equal to 110/180 mmHg History of secondary hypertension (e.g., hyperaldosteronism, pheochromocytoma, renal artery stenosis, Cushing's syndrome) Endocrine disruption symptoms such as renal failure, congestive heart failure, myocardial infarction, or cerebrovascular accidents from the 6 months prior to the study onset The presence of any type of cardiac arrhythmia (such as second- or third-degree blocks) Symptomatic heart valve disease (except for mitral valve prolapse) Type 1 and type 2 diabetic patients Clinically significant renal and hepatic dysfunction, i.e., creatinine greater than 1.5 times the maximum normal and alanine aminotransferase more than 3 times the normal maximum Number of platelets less than -100,000 or partial thromboplastin time more than 1.5 Pregnancy or breastfeeding intentions Known or potential allergy to the tested product Participation in any other clinical trials at the same time or within the last 30 days History of malignancy treated or untreated in the last 5 years Chronic oral or intravenous treatment with corticosteroids Serum potassium greater than 5.2 or less than 3.5 milliequivalents in the first visit Consuming contraceptive pills or psychiatric drugs History of drug abuse, alcohol abuse, etc. Any disruption (medical or surgical) that can interfere with the study according to the investigator or another serious illness The patient's inappropriate cooperation in the project or compromising the patient’s safety or the incidence of any potential adverse effect by the drug Childbirth during the project I10 Essential (primary) hypertension Treatment - Drugs Placebo Intervention Group (cheese-water): 50 grams of cheese-water powder dissolved in bristled water consumed twice daily before meals in the morning and evening for 6 weeks. Control Group (maltodextrin): 50 grams of maltodextrin powder diluted in bristled water consumed twice daily before meals in the morning and evening for 6 weeks Systolic and diastolic blood pressure. Timepoint: Every two weeks from the study onset to two weeks after intervention. Method of measurement: Sphygmomanometer. Sleep quality. Timepoint: Every two weeks from the study onset to two weeks after intervention. Method of measurement: Pittsburgh Sleep Quality Index. Weight loss or gain. Timepoint: Every two weeks from the study onset to two weeks after intervention. Method of measurement: Digital scale. Iran University of Medical Sciences Approved 2017-11-21 Ethics Committee of Iran University of Medical Sciences Hemmat Highway Tehran Tehran Iran (Islamic Republic of)