Protocol summary
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Study aim
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Determining the effect of jujube extract syrup on hemodynamic parameters in patients with hypertension
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Design
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Clinical trial with a control group, with parallel groups, without blinding, randomized, phase 3 on 34 patients. PASS software will be used for randomization.
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Settings and conduct
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This study will be with the participation of patients with primary or uncontrolled hypertension refer to Bahlul clinic. after
Examination of people the samples will be randomly assigned to two groups of control and intervention by the method of 4 permutation blocks. For subsequent measurements, within two month (every two weeks), the patient's blood pressure will be recorded at the office of the same specialist doctor. became. In addition to the routine treatment, the intervention group was given jujube syrup and they were asked to consume 5 cc twice a day. It should be noted that the participants in the intervention group will not be deprived of changing their routine treatment and adding a new drug due to blood pressure control in the present plan. In order to ensure regular consumption and prevent forgetting to take the medicine, a table including the number of study days to fill the desired cell in the intake rounds will also be given to them.
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Participants/Inclusion and exclusion criteria
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Entry conditions: non-diabetic people, willing to participate in the study, having systolic blood pressure above 14 and diastolic above 8 confirmed by a doctor and not controlled for at least one year, age 30 to 60 years
Conditions of non-entry: having cardiovascular diseases, pregnancy, breastfeeding
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Intervention groups
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Control group: usual treatment protocol
Intervention group: (in addition to routine treatment) jujube syrup was given and they were asked to consume 5 cc (equivalent to one tablespoon) twice a day.
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Main outcome variables
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Systolic and diastolic blood pressure; Pulse; Heart beat; Complete blood count
General information
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Reason for update
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There was a typo in the Persian title.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20240622062206N1
Registration date:
2024-07-24, 1403/05/03
Registration timing:
registered_while_recruiting
Last update:
2024-07-30, 1403/05/09
Update count:
1
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Registration date
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2024-07-24, 1403/05/03
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2024-07-02, 1403/04/12
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Expected recruitment end date
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2024-09-02, 1403/06/12
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effect of the Ziziphus Jujuba extract syrup administration on hemodynamic parameters in hypertensive patients
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Public title
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Ziziphus Jujuba extract syrup in hypertension
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Non-diabetic people
Having systolic blood pressure above 14 and diastolic above 8, confirmed by a doctor and not controlled for at least one year
Willingness to participate in the study
Exclusion criteria:
Having cardiovascular diseases
Pregnancy
Breastfeeding
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Age
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From 30 years old to 60 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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No information
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Sample size
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Target sample size:
34
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Based on the method of the permutation blocks of size 4, individuals are randomly divided into two groups. Samples will be divided into two experimental and control groups based on permutation blocks (blocks of size 4). It will be listed according to six possible ways (AABB, ABAB, ...) randomly and the arrangement of receiving intervention will be determined accordingly
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2024-03-12, 1402/12/22
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Ethics committee reference number
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IR.MUMS.MEDICAL.REC.1403.091
Health conditions studied
1
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Description of health condition studied
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Hypertension
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ICD-10 code
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I10
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ICD-10 code description
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Essential (primary) hypertension
Primary outcomes
1
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Description
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The percentage of people who have blood pressure above 140.80 mm Hg
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Timepoint
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Measurement of high blood pressure at the beginning of the study (before the start of the intervention) and 2, 4, 6 and 8 weeks after starting jujube syrup consumption.
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Method of measurement
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Digital sphygmomanometer
Intervention groups
1
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Description
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Intervention group: about 10 grams of dried seedless jujube is mixed and mixed with 300 cc of 80% ethanol for 6 hours, and then extraction is done with different filters and pulp is removed, and finally the extract is concentrated under the temperature of the incubator. In the next step, according to the optimal dose of jujube extract in animal blood pressure studies (200 mg/kg of animal weight) (10), the human dose is calculated as one-seventh and 30 mg per kilogram of human weight. Therefore, for humans A total dose of 60 kg is 1800 mg of extract. The syrup will be prepared with a concentration of 900 mg of extract per 5 cc and each person will use 10 cc of syrup per day for two months. 900 mg in 5 cc, the concentration of jujube extract in the syrup will be 18%
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Category
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Treatment - Drugs
2
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Description
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Control group: They use their common hypertension drugs to control their blood pressure for 2 months
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Mashhad University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available