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IRCT20220821055757N1 IRCT 2023-04-10 Khoram-Abad University of Medical Sciences Investigating the effect of ginger capsules on blood pressure. Investigation of the effect of the formulated ginger rhizome capsule on blood pressure in prehypertensive patients. 2023-03-21 anticipated 84 Complete https://irct.ir/trial/65596 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Prevention of high blood pressure, without complications and acceptable to patients, Randomization description: Patients will be divided into two groups using the stratified blocked randomization method. In this way, considering the gender (female, male), a stratum will be formed and within this stratum, the samples in the form of four blocks will be randomly assigned to the desired groups.classes are considered in order to match the two study groups of gender and BMI (thin and normal, obese and overweight).in this study, four classes are formed and the samples are randomly assigned to the subject group in the form of blocks of four.study will be assigned.in the present study,76 people were treated, 38 patients were treated with the original drug and 38 patients were treated with placebo.In this study, the 4-layer randomized block method is used to randomly assign patients to two groups A (drug group) and group B (control group). To do this, first by considering the classes as the age range (70-30) and over 70 years within each class, a list of blocks is written and numbers are assigned to them. (AABB (1) - ABAB (2) -ABBA (3) -BBAA (4) - BABA (5) - BAAB (6)). Then, using a table of random numbers, the numbers between one to 6 (for example, 1,4,5, etc.) are randomly selected, and finally the list of treatment assignments will be formed based on a sequence of letters A and B, Blinding description: This study is a double blind and the patient, the treatment evaluator are unaware of the experimental group.medicines are made in the same way,the patient and the person who gives the medicine to the patient have no information about the type and content of the medicine. 3 Prehypertension. Intervention 1: The intervention group: In this group, a capsule containing 26 mg of the active constituents gingerol is used at a daily dose of 1 capsule for 2 months (After purchasing the gingerol standard kit from KIA ZIST Hamedan company, the capsules were prepared in the laboratory of Khorram Abad Faculty of Pharmacy). Intervention 2: Control group: Actually, they are the placebo group, which have the characteristics of the intervention group, but they receive capsules containing 400 mg of wheat starch. 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 Due to the exclusive formulation of the drug,i have no decision to share the data at the moment.
public Hossein Beiranvand
No.49,Farabi Alley2,Nasser Khosrow St
Koram Abad Iran (Islamic Republic of) 133456789765432 +98 66 3327 3230 beiranvand_hossein@yahoo.com Khoram-Abad University of Medical Sciences scientific Hossein Beiranvand
No.49,Farabi Alley2,Nasser Khosrow St
Koram Abad Iran (Islamic Republic of) 133456789765432 +98 66 3327 3230 beiranvand_hossein@yahoo.com Khoram-Abad University of Medical Sciences Iran (Islamic Republic of) Patients who have received a diagnosis of hypertension within the maximum last three months. Patient consent to enter the study. The age of the patients is between 30 and 70 years. 30 years 70 years Both Patients with diabetes. Patients with high blood pressure. Patients with blood disorders. Treatment - Drugs Placebo The intervention group: In this group, a capsule containing 26 mg of the active constituents gingerol is used at a daily dose of 1 capsule for 2 months (After purchasing the gingerol standard kit from KIA ZIST Hamedan company, the capsules were prepared in the laboratory of Khorram Abad Faculty of Pharmacy). Control group: Actually, they are the placebo group, which have the characteristics of the intervention group, but they receive capsules containing 400 mg of wheat starch. Systolic and diastolic blood pressure (main variable). Timepoint: At the beginning of the study (before intervention) and 4, 8 weeks after the start of taking ginger capsules. Method of measurement: Mercury sphygmomanometer. Cholesterol. Timepoint: At the beginning of the study (before intervention) and 4, 8 weeks after the start of taking ginger capsules. Method of measurement: Chemistry Analyzer. Triglycerides. Timepoint: At the beginning of the study (before intervention) and 4, 8 weeks after the start of taking ginger capsules. Method of measurement: Chemistry Analyzer. Low Density Lipoprotein (LDL). Timepoint: At the beginning of the study (before intervention) and 4, 8 weeks after the start of taking ginger capsules. Method of measurement: Chemistry Analyzer. Nitric oxide metabolites. Timepoint: At the beginning of the study (before intervention) and 4, 8 weeks after the start of taking ginger capsules. Method of measurement: Nitric oxide assay kit. Khoram-Abad University of Medical Sciences Approved 2021-01-20 Ethics committee of Lorestan University of Medical Sciences Lorestan, Khorramabad, 3 km of Khorramabad Road, Tehran, Pardis University Complex, Vice Chancellor for Research and Technology, Lorestan University of Medical Sciences, Office of Research Ethics Committee Khorramabad Lorestan Iran (Islamic Republic of)