This study aims to evaluate the efficacy of Barij syrup in hypertensive patients. informed consent ( blinded study). Therefore patients aren't aware of their therapeutic group they will be assigned. In addition, neither patients nor medical staff will be aware of the type of oils in the container (Barij syrup or placebo). Only the researcher is aware of the code written on the container of the syrups ; so, this study is a double-blind, parallel clinical trial. Hypertensive patients with SBP /DBP ≥ 140/90 mmHg were eligible for inclusion. fifty of patients attending the Shahid beheshti who meet our inclusion criteria will take part in this study. By using random numbers (created by throwing coin and dice ) subjects will randomly allocate to one of two experimental groups: a placebo and a test group. Thus, 25 cases in each treatment arm receive placebo or Barij syrup . In the intervention group, 30 ml oral Barij syrup is administered daily for 3 months . Patients in the control group receive placebo in the same way. Systolic and diastolic pressure (during intervention) will be checked as primary outcomes.
Design
Randomised controlled clinical trial and double blind, parallel study
Settings and conduct
This study is conducted at Shahid Beheshti Hospital in Qom and is blinded by placebo
Participants/Inclusion and exclusion criteria
Inclusion criteria :Patient with stage I hypertension (Systolic Blood Pressure 140-159 mmHg, Diastolic Blood Pressure) 90-99 mmHg) Exclusion criteria:Pregnant women or women planning to get pregnant, Being allergic to Barıj syrups, Suffering from intestinal diseases such as Crohn's disease, colitis, peptic ulcer, irritable bowel syndrome (IBS), History of myocardial infarction, coronary bypass surgery during last 6 month
Intervention groups
Patient with stage 1 hypertension
Main outcome variables
Systolic blood pressure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170112031893N1
Registration date:2018-04-07, 1397/01/18
Registration timing:prospective
Last update:2018-04-07, 1397/01/18
Update count:0
Registration date
2018-04-07, 1397/01/18
Registrant information
Name
Hossein Yusefi
Name of organization / entity
Qom University of medical science
Country
Iran (Islamic Republic of)
Phone
+98 25 3886 0146
Email address
driran1399@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-21, 1397/02/01
Expected recruitment end date
2019-04-21, 1398/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Barij blood pressure syrup products in patients with hypertension: a double blind randomized placebo controlled trial
Public title
Evaluation of Barij blood pressure syrup products in patients with hypertension
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient with stage I hypertension (Systolic Blood Pressure (SBP) 140-159 mmHg, Diastolic Blood Pressure (DBP) 90-99 mmHg) and not using a particular anti-hypertensive therapy
Exclusion criteria:
Pregnant women or women planning to get pregnant
Being allergic to Barıj syrups
Suffering from intestinal diseases such as Crohn's disease, colitis, peptic ulcer, irritable bowel syndrome (IBS)
History of myocardial infarction; coronary bypass surgery during last 6 month
Age
From 25 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization by Throwing coin and dice
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, patients, statistical analyst and physicians are not aware of the allocation of drugs and placebo, and someone outside the group is aware of the allocation of treatment.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Qom University of Medical Sciences
Street address
Vice chancellor for research of Qom University of Medical Sciences, Safashar road, Qom, Iran
City
qom
Province
Ghoum
Postal code
87366-37169
Approval date
2018-02-06, 1396/11/17
Ethics committee reference number
IR.MUQ.REC.1396.135
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
Systolic blood pressure
Timepoint
Prior to study, second week, fourth week , eighth week and at the end of study
Method of measurement
In mmHg using mercuric manometer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Barij syrup. (A natural combination of chicory, tangerine, malt extract, sesame, sour lemon, sweet almond produced by Barij company ) 30 ml oral Barij syrup is administered daily for three months
Category
Treatment - Drugs
2
Description
Control group: Placebo syrup 30 ml daily for three months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahıd beheshtı hospital
Full name of responsible person
Seyyed fakhreddin hejazi
Street address
Clinical Research Development Center, Shahid Beheshti Hospital, Shahid Beheshti Blvd, Azadegan Sq, Qom, Iran
City
qom
Province
Ghoum
Postal code
3719976739
Phone
+98 25 3886 0146
Email
Huqom1394@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Barij Essence Company
Full name of responsible person
Mohsen Taghizadeh
Street address
Barij Essence Company, Kashan
City
Kashan
Province
Isfehan
Postal code
3716987366
Phone
+98 25 3886 0146
Email
taghizadeh_m@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Barij Essence Company
Proportion provided by this source
75
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry
2
Sponsor
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
hossein saghafi
Street address
Namber 83, Alley 4, Alley 1.1, Safashahr Street
City
Qom
Province
Ghoum
Postal code
3716987366
Phone
+98 25 3285 2720
Email
huqom1394@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ghoum University of Medical Sciences
Proportion provided by this source
25
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
Ghoum University of Medical Sciences
Full name of responsible person
Hossein moradi
Position
Professor of Iranian traditional medicine
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Faculty of Traditional Iranian Medicine, Third Floor, Faculty of Dentistry,Saheli St. Qom.Iran
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3770 7843
Email
moradi.medicine@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Hossein moradi
Position
Professor of Iranian traditional medicine
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Faculty of Traditional Iranian Medicine, Third Floor, Faculty of Dentistry,Saheli St. Qom.Iran
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3770 7843
Email
moradi.medicine@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Muhammad hosseın yusefi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Internal medicine
Street address
Clinical Research Development Center, Shahid Beheshti Hospital, Shahid Beheshti Blvd, Azadegan Sq, Qom, Iran
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3886 0146
Email
driran1390@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
With attention due to the type of study and publication of the article, there was no need to mention this
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not 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