View older revisions Content changed at 2024-07-30, 1403/05/09

Protocol summary

Study aim
Determining the effect of jujube extract syrup on hemodynamic parameters in patients with hypertension
Design
Clinical trial with a control group, with parallel groups, without blinding, randomized, phase 3 on 34 patients. PASS software will be used for randomization.
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
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
Intervention groups
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.
Main outcome variables
Systolic and diastolic blood pressure; Pulse; Heart beat; Complete blood count

General information

Reason for update
There was a typo in the Persian title.
Acronym
IRCT registration information
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
Registration date
2024-07-24, 1403/05/03
Registrant information
Name
Nasim Khajavian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5725 7678
Email address
khajavian.n@gmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-02, 1403/04/12
Expected recruitment end date
2024-09-02, 1403/06/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of the Ziziphus Jujuba extract syrup administration on hemodynamic parameters in hypertensive patients
Public title
Ziziphus Jujuba extract syrup in hypertension
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 30 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 34
Randomization (investigator's opinion)
Randomized
Randomization description
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
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of School of Medicine of Mashhad University of Medical Sciences
Street address
Faculty of Medicine, East Gate of University Campus, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Approval date
2024-03-12, 1402/12/22
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1403.091

Health conditions studied

1

Description of health condition studied
Hypertension
ICD-10 code
I10
ICD-10 code description
Essential (primary) hypertension

Primary outcomes

1

Description
The percentage of people who have blood pressure above 140.80 mm Hg
Timepoint
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.
Method of measurement
Digital sphygmomanometer

Secondary outcomes

empty

Intervention groups

1

Description
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%
Category
Treatment - Drugs

2

Description
Control group: They use their common hypertension drugs to control their blood pressure for 2 months
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Bohlool hospital
Full name of responsible person
Reza Mohebbati
Street address
Sadi Ave., Parastar Blvd.
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5723 6833
Email
mohebbatir@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
3rd floor, University of Medical Sciences, next to Hoize cinema, University St.
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
TafaghodiM@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Reza Mohebbati
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Gonabad University of Medical Sciences campus, On the side of Asian Road
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
009857223028
Email
mohebbatir@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Reza Mohebbati
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Gonabad University of Medical Sciences campus, On the side of Asian Road
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
009857223028
Email
mohebbatir@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Reza Mohebbati
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Gonabad University of Medical Sciences campus, On the side of Asian Road
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
009857223028
Email
mohebbatir@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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