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A clinical trial comparing the effects of placebo and the Iranian traditional medicinal product of mao’ljabn or cheese-water on primary hypertension

Protocol summary

Study aim
To determine the impact of mao’ljabn or cheese-water on primary hypertension
Design
This clinical trial will be performed on patients aged 18 to 80 years with hypertension in stage 1. The patients include those who refer to Birjand Cardiovascular Clinic and are being treated with hypotensive drugs but whose blood pressure is not controlled yet. The patients will be randomly assigned into intervention and control groups via simple randomization.
Settings and conduct
Patients are randomly assigned into cheese water and placebo groups via simple randomization method and in blocs of 4. The intervention group receives 50 grams of cheese-water powder dissolved in bristled water twice daily before meals in the morning and evening for 6 weeks. The control group receives 50 grams of maltodextrin powder diluted in bristled water twice daily before meals in the morning and evening for 6 weeks. Patients are visited by the researcher every two weeks and by a cardiologist once a month.
Participants/Inclusion and exclusion criteria
Main inclusion criteria: Men and women aged 18 to 80 years; Being in the first stage of hypertension (i.e., systolic blood pressure greater than or equal to 140, and diastolic blood pressure greater than or equal to 90 mmHg based on the new definition of the Joint National Committee-8; Being treated with blood pressure medication (one to a maximum of three drugs based on the protocol), but the patient’s blood pressure is uncontrolled and still in stage 1 hypertension; minimum of one month passed from the onset of drug consumption; body mass index below 30. Main exclusion criteria: Stage 2 or above according to hypertension classification of the Joint National Committee-VIII; blood pressure greater than or equal to 110/180 mmHg; history of secondary hypertension (e.g., hyperaldosteronism, pheochromocytoma, renal artery stenosis, Cushing's syndrome); endocrine disruption symptoms such as renal failure, congestive heart failure, myocardial infarction, or cerebrovascular accidents from the 6 months prior to the study onset; the presence of any type of cardiac arrhythmia (such as second- or third-degree blocks); and symptomatic heart valve disease (except for mitral valve prolapse)
Intervention groups
Intervention Group (cheese-water): 50 grams of cheese-water powder dissolved in bristled water consumed twice daily before meals in the morning and evening for 6 weeks. Control Group (maltodextrin): 50 grams of maltodextrin powder diluted in bristled water consumed twice daily before meals in the morning and evening for 6 weeks
Main outcome variables
Change in systolic and diastolic blood pressure; Sleep quality

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20140519017756N34
Registration date: 2018-01-30, 1396/11/10
Registration timing: registered_while_recruiting

Last update: 2018-01-30, 1396/11/10
Update count: 0
Registration date
2018-01-30, 1396/11/10
Registrant information
Name
Mohammad Bagher Roozgar
Name of organization / entity
Birjand University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 3239 5680
Email address
mbroozgar@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-11-22, 1396/09/01
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial comparing the effects of placebo and the Iranian traditional medicinal product of mao’ljabn or cheese-water on primary hypertension
Public title
Impact of mao’ljabn or cheese-water on primary hypertension
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Being in stage 1 hypertension (i.e., systolic blood pressure greater than or equal to 140, and diastolic blood pressure greater than or equal to 90 mmHg based on the new definition of the Joint National Committee-8 Being treated with blood pressure medication (one to a maximum of three drugs based on the protocol), but the patient’s blood pressure is uncontrolled and still in stage 1 hypertension A minimum of one month passed from the onset of drug consumption Body mass index below 30 Age between 18 and 80 years
Exclusion criteria:
Stage 2 or above according to hypertension classification of the Joint National Committee-VIII Blood pressure greater than or equal to 110/180 mmHg History of secondary hypertension (e.g., hyperaldosteronism, pheochromocytoma, renal artery stenosis, Cushing's syndrome) Endocrine disruption symptoms such as renal failure, congestive heart failure, myocardial infarction, or cerebrovascular accidents from the 6 months prior to the study onset The presence of any type of cardiac arrhythmia (such as second- or third-degree blocks) Symptomatic heart valve disease (except for mitral valve prolapse) Type 1 and type 2 diabetic patients Clinically significant renal and hepatic dysfunction, i.e., creatinine greater than 1.5 times the maximum normal and alanine aminotransferase more than 3 times the normal maximum Number of platelets less than -100,000 or partial thromboplastin time more than 1.5 Pregnancy or breastfeeding intentions Known or potential allergy to the tested product Participation in any other clinical trials at the same time or within the last 30 days History of malignancy treated or untreated in the last 5 years Chronic oral or intravenous treatment with corticosteroids Serum potassium greater than 5.2 or less than 3.5 milliequivalents in the first visit Consuming contraceptive pills or psychiatric drugs History of drug abuse, alcohol abuse, etc. Any disruption (medical or surgical) that can interfere with the study according to the investigator or another serious illness The patient's inappropriate cooperation in the project or compromising the patient’s safety or the incidence of any potential adverse effect by the drug Childbirth during the project
Age
From 18 years old to 80 years old
Gender
Both
Phase
2
Groups that have been masked
  • Participant
  • Data analyser
Sample size
Target sample size: 112
Randomization (investigator's opinion)
Randomized
Randomization description
Participants are allocated into study groups via simple random allocation.
Blinding (investigator's opinion)
Double blinded
Blinding description
The participants are explained about the study objectives and procedures. Nonetheless, neither the patients nor the researchers know who has received the experimental drug.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Iran University of Medical Sciences
Street address
Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2017-11-21, 1396/08/30
Ethics committee reference number
IR.IUMS.REC1396.9311661001

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 and diastolic blood pressure
Timepoint
Every two weeks from the study onset to two weeks after intervention
Method of measurement
Sphygmomanometer

2

Description
Sleep quality
Timepoint
Every two weeks from the study onset to two weeks after intervention
Method of measurement
Pittsburgh Sleep Quality Index

Secondary outcomes

1

Description
Weight loss or gain
Timepoint
Every two weeks from the study onset to two weeks after intervention
Method of measurement
Digital scale

Intervention groups

1

Description
Intervention Group (cheese-water): 50 grams of cheese-water powder dissolved in bristled water consumed twice daily before meals in the morning and evening for 6 weeks.
Category
Treatment - Drugs

2

Description
Control Group (maltodextrin): 50 grams of maltodextrin powder diluted in bristled water consumed twice daily before meals in the morning and evening for 6 weeks
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Hekmat-e Shargh Traditional Medicine Clinic
Full name of responsible person
Dr Maryam Navabzadeh
Street address
Taleghani St.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3239 5000
Email
mnavab94@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Seyed Kazem Malekouti
Street address
Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
kmalakouti@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
70
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
Iran University of Medical Sciences
Full name of responsible person
Dr Maryam Navabzadeh
Position
PhD Candidate of Iranian Traditional Medicine
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Ghaffari St.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3239 5000
Email
mnavab94@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Maryam Navabzadeh
Position
PhD Candidate of Iranian Traditional Medicine
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Ghaffari St.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3239 5000
Email
mnavab94@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Mohammad Bagher Roozgar
Position
PhD Candidate of Translation Studies
Latest degree
Master
Other areas of specialty/work
Translation
Street address
Ghaffari St.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3239 5680
Email
hadirooz@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Deidentified Individual Participant Data Set can be provided to other researchers.
When the data will become available and for how long
after the study report is published as a paper and for 2 years since the paper is published
To whom data/document is available
researchers who ask for it
Under which criteria data/document could be used
no certain criteria
From where data/document is obtainable
the personal email of researchers
What processes are involved for a request to access data/document
personal correspondence
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