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IRCT20200506047325N2 IRCT 2023-05-31 Gorgan University of Medical Sciences Investigating the effective concentration of jujube fruit in primary hypertension Investigating the pharmacological effect of jujube fruit hydroalcoholic extract (Ziziphus jujuba Mill.) in patients with primary hypertension: a pilot study 2023-06-22 anticipated 40 Complete https://irct.ir/trial/69988 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The random assignment list will be computer generated with a 1:1 allocation, stratified by recruitment site, using random block size of four. Using concealed in sequentially numbered, sealed, opaque envelopes (SNOSE), participants will enter the blocks in such a way that an equal number of each assigned group. Allocation will be done by randomly selecting one of the arrangements and assigning the next part of the participants to the study groups according to the specified sequence. And kept by the hospital pharmacist of the center. 1 Essential (primary) hypertension. Intervention 1: Intervention group: recipient of routine drug treatment + Ziziphus jujuba fruit extract (7 g/day) for 4 weeks. Intervention 2: Intervention group: recipient of routine drug treatment + Ziziphus jujuba fruit extract (14 g/day) for 4 weeks. Intervention 3: Intervention group: recipient of routine drug treatment + Ziziphus jujuba fruit extract (28 g/day) for 4 weeks. Intervention 4: Control group: receiving routine medical treatment + placebo Ziziphus jujuba fruit extract 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 There is no further information
public Aref Salehi
Shastkola Road
Gorgan Iran (Islamic Republic of) 14395-477 +98 17 3245 1434 salehia@goums.ac.ir Gorgan University of Medical Sciences scientific Ayesheh Enayati
Shastkola Road
Gorgan Iran (Islamic Republic of) 14395-477 +98 17 3245 1434 enayati_phyto@yahoo.com Gorgan University of Medical Sciences Iran (Islamic Republic of) mmHg160 < blood pressure < mmHg 120 (Pre- and stage 1 hypertension) Voluntary participation in this clinical study and written consent 18 years no limit Both Other heart diseases Secondary hypertension Serum potassium> 5.5 mmol / L or <3.5mmol / L Doubling of serum creatinine in the last 6 months Severe complications of diabetes or seriousmacrovascular events within 6 months (e.g., cerebral hemorrhage, cerebral infarction, or acute myocardial infarction) Recent infection in the last 4 weeks Primary or secondary kidney disease (e.g., IgA nephropathy, membranous nephropathy, or lupus nephritis) Any cancer and malignancy Severe mental disorder Pregnant or lactating women or women who are planning to become pregnant or women who arenot using appropriate contraceptive methods Participate in other clinical trials Drug or jujube allergies Use of other herbal medicines to control the symptoms of the present disease History of smoking, drugs Other conditions that the researchers considered in appropriate in this clinical study I10 Essential (primary) hypertension Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: recipient of routine drug treatment + Ziziphus jujuba fruit extract (7 g/day) for 4 weeks Intervention group: recipient of routine drug treatment + Ziziphus jujuba fruit extract (14 g/day) for 4 weeks Intervention group: recipient of routine drug treatment + Ziziphus jujuba fruit extract (28 g/day) for 4 weeks Control group: receiving routine medical treatment + placebo Ziziphus jujuba fruit extract for 4 weeks Hypertension. Timepoint: Round 0: starting the study and receiving medication (face-to-face consultation)Round 1: 2 weeks after receiving the drug (telephone)The third round: the fourth week, the end of the medical treatment period (face-to-face consultation). Method of measurement: Mercury barometer. Change in serum creatinine (SCr). Timepoint: At the beginning of the study and at the end of the drug treatment period (4th week). Method of measurement: Blood and urine tests. EGFR. Timepoint: At the beginning of the study and at the end of the drug treatment period (4th week). Method of measurement: Blood and urine tests. Serum Albumin. Timepoint: At the beginning of the study and at the end of the drug treatment period (4th week). Method of measurement: Blood and urine tests. Lipid profiles. Timepoint: At the beginning of the study and at the end of the drug treatment period (4th week). Method of measurement: Blood tests. ECG. Timepoint: At the beginning of the study and at the end of the drug treatment period (4th week). Method of measurement: Electrocardiograph. Liver enzymes. Timepoint: At the beginning of the study and at the end of the drug treatment period (4th week). Method of measurement: Blood tests. Gorgan University of Medical Sciences Approved 2023-04-25 Ethics committee of Golestan University of Medical Sciences Shastkola Road gorgan Golestan Iran (Islamic Republic of)