The explanation of the causes of high blood pressure and its therapies in Persian medicine and the effect of Lemongrass herbal product in primary blood pressure control
Explain the causes of hypertension and its treatment based on persian medicine and determine the effectiveness of the product of lemon balm on primary hypertension.
Design
This study is a double-blind, Crossover, randomized clinical trial. The sample size is 24 patients in each group , which according to the cross-sectional study, the total results of 48 patients in each group will be examined. Patients are divided into two groups of medication and placebo.
Settings and conduct
Patients are randomly assigned to receive four weeks of medication and four weeks of placebo. The washout period is considered two weeks. In this double blind study, the researcher and the patient will not be informed about how to receive capsules in the intervention and control groups until the end of the study.
Participants/Inclusion and exclusion criteria
Major inclusion criteria: Men and women aged 30-75 years, with a systolic blood pressure greater than or equal to 140 and a diastolic blood pressure greater than or equal to 90 mmHg, are treated with a blood pressure medication (one to three drugs based on the protocol). Major exclusion criteria: presence of blood pressure greater than or equal to 110/180 mm Hg, history of secondary hypertension, end-organ damage symptoms 6 months before the start of the study, history of hypo or hyperthyroidism.
Intervention groups
Adding a Melitropic capsule to the medication regimen in the intervention group, control group: placebo capsule
Main outcome variables
Change in blood pressure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170820035796N2
Registration date:2019-01-08, 1397/10/18
Registration timing:registered_while_recruiting
Last update:2019-01-08, 1397/10/18
Update count:0
Registration date
2019-01-08, 1397/10/18
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2277 0208
Email address
z.shekarriz@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-23, 1397/08/01
Expected recruitment end date
2019-02-20, 1397/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The explanation of the causes of high blood pressure and its therapies in Persian medicine and the effect of Lemongrass herbal product in primary blood pressure control
Public title
Evaluation of the effect of lemon balm plant on primary blood pressure control
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Men and women 30-75 years old
ُُSystolic blood pressure greater than or equal to 140, and diastolic blood pressure greater than or equal to 90 mmHg being treated with blood pressure medication (one to three drugs based on the protocol), but the patient’s blood pressure is uncontrolled
At least one month has elapsed since the onset of drug use
Have informed consent to participate in the study.
Exclusion criteria:
Blood pressure equal to or greater than 110/180 at the start of the study or during intervention
History of secondary hypertension
Major symptoms of major organ damage (such as renal failure, congestive heart failure, myocardial infarction, or cerebrovascular accidents) During the 6 months before the study
The presence of any type of cardiac arrhythmia (such as second- or third-degree blocks)
Symptomatic valvular disease
Liver dysfunction
Type 1 and type 2 diabetic patients with impaired renal and liver function to the extent that clinically significant (ie more than 1.5 times the maximum normal creatinine and alanine aminotransferase more than 3 times the normal maximum)
Low platelet count More than 100,000 per microliter of blood
History of treated or untreated malignancies
Potassium greater than 1.5 or less than 3.5 mg / L in the first visit
History of hypothyroidism or hyperthyroidism
Pregnancy and lactation
The presence of any medical or surgical disorder that could interfere with the study.
Age
From 30 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
The patients are categorized into two groups A and B by block randomizarion method.In the first four weeks, group A receives drug and group B placebo and after the washout period, group A receives placebo and group B drug. Unit of randomization is individual and samples are allocated by the software "random allocation". The samples are grouped in 12 blocks of 4.
Blinding (investigator's opinion)
Double blinded
Blinding description
melitropic and placebo capsules with quite the same shape and color and weight will be produced and packaged in quite the same and will be one color and one shape.After the washout period, melitropic and placebo will be changed for each patient. A code will be randomly assigned to each box with the help of software. The expert will give it to the patient accidentally and without knowledge of the type of medicine. Thus the nature of each code will be unclear until the results are analyzed. The investigator, expert and patient will not be aware of the code in the container.
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Sciences
Street address
Deputy of Research and Technology Mazandaran University of Medical Sciences, Moalem Ave., Moalem Square
City
Sari
Province
Mazandaran
Postal code
48168-95474
Approval date
2018-09-26, 1397/07/04
Ethics committee reference number
IR.MAZUMS.REC.1397.156
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
Blood pressure
Timepoint
In baseline and 5 times follow up measurement every 2 weeks
Method of measurement
Sphygmomanometer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Miliotropic capsule containing 400 mg of lemon balm daily three times a day for 4 weeks
Category
Treatment - Drugs
2
Description
Control group: The capsule contains 400 mg of lactose daily three times a day for 4 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Tooba clinic
Full name of responsible person
Seyde Sedighe Yousefi
Street address
Tooba clinic, Khazar Blvd., Khazar Square
City
Sari
Province
Mazandaran
Postal code
48168-95474
Phone
+98 11 3324 4893
Fax
+98 11 3324 4894
Email
s.yousefi@mazums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Majid Saeedi
Street address
Deputy of Research and Technology Mazandaran University of Medical Sciences, Moalem Ave., Moalem Square
City
Sari
Province
Mazandaran
Postal code
861-48175
Phone
+98 11 3325 7230
Email
m.saeedi@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sari 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
Mazandaran University of Medical Sciences
Full name of responsible person
Seyde Sedighe Yousefi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Traditional and Complementary Medicine Reseach Centre, Khazar Blvd., Khazar square
City
Sari
Province
Mazandaran
Postal code
48168-95475
Phone
+98 11 3324 4893
Fax
+98 11 3324 4894
Email
z.shekarriz@mazums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Seyde Sedighe Yousefi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Traditional and Complementary Medicine Reseach Centre, Khazar Blvd., Khazar square
City
Sari
Province
Mazandaran
Postal code
48168-95475
Phone
+98 11 3324 4893
Fax
+98 11 3324 4894
Email
s.yousefi@mazums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Zahra Shekarriz
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Traditional and Complementary Medicine Reseach Centre, Khazar Blvd., Khazar square
City
Sari
Province
Mazandaran
Postal code
48168-95475
Phone
+98 11 3324 4893
Fax
+98 11 3324 4894
Email
z.shekarriz@mazums.ac.ir
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
No - There is not 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