1. Assess the effect of Cretaegus on control of hypertension
2. Assess the effect of Cretaegus on control of hypertension base on dose of consumption of hypertension drugs
3. Assess the effect of Cretaegus on control of hypertension base on the number of drugs in order to control of hypertension
4. Assess the effect of Cretaegus on control of hypertension base on stage of hypertension
Design
Two arm parallel groups randomized trial with blinded outcome and assessment. Phase 3 with 110 participators will start.
Randomization was was centralized and computerized with concealed randomization sequence carried out at an external site.
Settings and conduct
The study will be done on hypertension patients refer to Imam Hossien hospital of Shahroud. After grouping and beginning of treatment protocol, patients will be assessed at end of 8,10,12,14,16 week. Also, because we use pocket for grouping, analyzer and nurse who assess the patients are blinded
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. Primary hypertension patients ( systolic pressure more than or equal 140 mmHg and/or diastolic pressure more than or equal 90 mmHg) that their systolic pressure less than 180 mmHg and diastolic pressure lower than 110 mmHg)
2. Patients written consent form
Exclusion criteria:
1.Patients do not tend to continue the project
2.Secondary hypertension patients
3.Patients with chronic kidney disease
4.Patients with high usage dose of cortone
5.Pregnant patients
6.Usage of digoxin
7.Usage of antiarrhythmic drugs (class II)
8.Usage of enoxaparin, warfarin, heparin
Intervention groups
First group: Crataegous drop will be prescribed three times a day and each time 20 drops for 4 month with their hypertension drugs.
second group: they only use in accordance to hypertension treatment protocol.
Main outcome variables
Blood pressure control
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200112046101N2
Registration date:2022-04-18, 1401/01/29
Registration timing:prospective
Last update:2022-04-18, 1401/01/29
Update count:0
Registration date
2022-04-18, 1401/01/29
Registrant information
Name
Erfan Kazemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 58 3226 4711
Email address
kazemi.e@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-22, 1401/04/01
Expected recruitment end date
2022-08-22, 1401/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assess the effect of Cretaegus herbal medicine on control of hypertension patients
Public title
Assess the effect of Cretaegus on hypertension
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Primary hypertension patients ( systolic pressure is more or equal to140 mmHg and/or diastolic pressure is more or equal to 90 mmHg) that their systolic pressure less than 180 mmHg and diastolic pressure lower than 110 mmHg)
Patients written consent form
Exclusion criteria:
Patients do not tend to continue the project
Secondary hypertension patients
Patients with chronic kidney disease
Patients with high usage dose of cortone
Pregnant patients
Usage of digoxin
Usage of antiarrhythmic drugs (class II)
Usage of enoxaparin, warfarin, heparin
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
110
Randomization (investigator's opinion)
Randomized
Randomization description
We used block randomization ( with 4 letters). Because , patients will be entered in the study gradually and having equal sample size in both groups. Therefor, 24 block that included of 4 letters will be made. The desired sequence have been made by this website (https://www.sealedenvelope.com/simple-randomiser/v1/lists )
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the nurse who measure the blood pressure and statistical counsellor are blinded. In this regard, we use 28 closed pockets which type of group determined inside of them. we number on each pockets. After, basic information of the patients written, a pocket will be opened and their type of group will be determined.
Placebo
Not used
Assignment
Parallel
Other design features
We do not use any placebo in this study
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahroud University of Medical Sciences
Street address
Shahroud University of Medical Sciences, 7 Tir square
City
Shahroud
Province
Semnan
Postal code
3614773943
Approval date
2022-03-09, 1400/12/18
Ethics committee reference number
IR.SHMU.REC.1400.135
Health conditions studied
1
Description of health condition studied
Essential hypertension
ICD-10 code
I10
ICD-10 code description
Essential (primary) hypertension
Primary outcomes
1
Description
Blood pressure control
Timepoint
At the beginning of the study, at end of 8, 10, 12, 14, 16 weeks
Method of measurement
Digital pressure gauge
Secondary outcomes
1
Description
Reducing the number of hypertension medicine
Timepoint
At end of 8, 10 12, 14 16 weeks
Method of measurement
The number of hypertension drugs are used to control blood pressure.
2
Description
Reducing consumed dose of the drugs
Timepoint
At the end of 8, 10, 12, 14, 16 weeks
Method of measurement
The amount of prescribed drug base on milligram per kilogram
Intervention groups
1
Description
Intervention group: The group used Cretaegus drop with hypertension drugs. They have to use the drop three times a day and each time include of 20 drops till 4 months . The drop is produced by Iran Darouk company
Category
Treatment - Drugs
2
Description
Control group: This group just use their common hypertension drugs to control their blood pressure for four months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein hospital of Shahroud
Full name of responsible person
Erfan Kazemi
Street address
Student research committee of medical university, 7 Tir square, Shahroud
City
Shahroud
Province
Semnan
Postal code
3614773943
Phone
+98 915 586 8605
Email
Erfankazemi305@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Mohammad Hassan Emamian
Street address
Student research committee, Shahroud university of medical science, 7 Tir square, Shahroud city, Semnan province, Iran
City
Shahroud
Province
Semnan
Postal code
3614773943
Phone
+98 915 586 8605
Email
Erfankazemi305@gmail.com
Grant name
Grant code / Reference number
99138
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahroud 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
Shahroud University of Medical Sciences
Full name of responsible person
Erfan Kazemi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Cardiology
Street address
Shahrud Medical University , 7 Tir Square, Shahrud
City
Shahrud
Province
Semnan
Postal code
3614773943
Phone
+98 58 3226 4711
Fax
Email
erfankazemi305@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Erfan Kazemi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Cardiology
Street address
Shahrud Medical University , 7 Tir Square, Shahrud
City
Shahrud
Province
Semnan
Postal code
3614773943
Phone
+98 58 3226 4711
Fax
Email
erfankazemi305@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Erfan Kazemi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Cardiology
Street address
Shahrud Medical University , 7 Tir Square, Shahrud
City
Shahrud
Province
Semnan
Postal code
3614773943
Phone
+98 58 3226 4711
Fax
Email
erfankazemi305@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
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
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available