Protocol summary

Study aim
Determine the effects of Crataegus monogyna on Hypertension
Design
By using random numbers table, patients are divided in two groups ,case and control. All participants and researchers are blind in this study, coding of medicine and placebo are under the responsibility of a statistical adviser who is not blind.
Settings and conduct
Dry extract of Crataegus Monogyna with a concentration of 10% relative to 100 gr of the plant, has been standardized 250mg per capsule at the school of pharmacy of Shahid Behest university of Medical Sciences.The drug is given one capsule every 12 hours for 60 days to volunteer patient with hypertension(the patients refer to special clinic Zanjan university of Medical science) Control group:Placebo in the control group contains starch corn which is provided in capsules and boxes of the same intervention group.the placebo is given one capsule every 12 hours for 60 days to volunteer patient with hypertension(the patients refer to special clinic Zanjan university of Medical science) All participations and researchers are blind in this study, coding of medicine and placebo are under the responsibility of a statistical adviser who isnot blind.
Participants/Inclusion and exclusion criteria
Informed study participation, age 35 to 60,Hypertension , continuing heart medications, prescribed by cardiologist. Pregnancy, Breast feeding, Malignancy, Sever hypertension, Chronic Inflamatory diseas, Renal failure, Sever liver disease, Acute infectious disease, Secondary hypertension, Age less than 35 and older than 60, Taking digoxin, Arryhthmia
Intervention groups
60 Patients have Hypertension at 35 to 60 years that conditions have in plan.30 person take placebo and 30 person take drug
Main outcome variables
1-Quality of sleep in the Pittsburgh Questionnaire 2- Systolic blood pressure 3- FBS,BUN,Cr,Hb, ALT,AST, TG

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180225038859N1
Registration date: 2018-05-26, 1397/03/05
Registration timing: registered_while_recruiting

Last update: 2018-05-26, 1397/03/05
Update count: 0
Registration date
2018-05-26, 1397/03/05
Registrant information
Name
masumeh abbasi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6689 3256
Email address
abbasi1393@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-22, 1397/03/01
Expected recruitment end date
2018-07-23, 1397/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The clinical trial of the effect of crataegus monogyna on hypertension and associated sleep disorders
Public title
Effect of Crataegus Monogyna in hypertension and associated sleep disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Hypertensive patient that they didn't respond to medical treatment
Exclusion criteria:
Pregnancy Breast feeding Malignancy Sever hypertension Chronic Inflamatory diseas Renal failure Sever liver disease Acute infectious disease Secondary hypertension Age less than 35 and older than 60 Taking digoxin Arryhthmia
Age
From 35 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
By using random numbers table patients are divided in two 30 person intervention or control groups
Blinding (investigator's opinion)
Triple blinded
Blinding description
All participations and researchers are blind in this study, coding of medicine and placebo are under the responsibility of a statistical adviser who is not blind
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Zanjan University of Medical Science
Street address
First of Jomhuri Blvd , Azadi Sq
City
Zanjan
Province
Zanjan
Postal code
۴۵۱۵۴
Approval date
2018-03-06, 1396/12/15
Ethics committee reference number
IR.ZUMS.REC.1396.301

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
Quality of sleep in the Pittsburgh Questionnaire
Timepoint
Measure the quality of sleep at the beginning of study(before intervention)and two week after taking the Crataegus Monogyna
Method of measurement
Pittsburgh sleep quality questionnaire in patients with hypertension

2

Description
Systolic blood pressure
Timepoint
Measure the Blood Pressure at the beginning of study(before intervention)and two week after taking the Crataegus Monogyna
Method of measurement
Blood Pressure Device

Secondary outcomes

1

Description
Fasting blood sugar test
Timepoint
Measure the FBS at the beginning of study(before intervention)and two week after taking the Crataegus Monogyna
Method of measurement
Blood Test

2

Description
Blood Urea Nitrogen
Timepoint
Measure the BUN at the beginning of study(before intervention)and two week after taking the Crataegus Monogyna
Method of measurement
Blood Test

3

Description
Hemoglobin
Timepoint
Measure the Hb at the beginning of study(before intervention)and two week after taking the Crataegus Monogyna
Method of measurement
Blood Test

4

Description
Creatinine
Timepoint
Measure the Cr at the beginning of study(before intervention)and two week after taking the Crataegus Monogyna
Method of measurement
Blood Test

5

Description
ALT and AST
Timepoint
Measure the ALT and ASTbat the beginning of study(before intervention)and two week after taking the Crataegus Monogyna
Method of measurement
Blood Test

6

Description
Triglyceride
Timepoint
Measure the TG at the beginning of study(before intervention)and two week after taking the Crataegus Monogyna
Method of measurement
Blood Test

Intervention groups

1

Description
Intervention group: Dry extract of Crataegus Monogyna with a concentration of 10% relative to 100 gr of the plant, has been standardized 250mg per capsule at the school of pharmacy of Shahid Behest university of Medical Sciences.The drug is given one capsule every 12 hours for 60 days to Voluptuous patient with hypertension.
Category
Treatment - Drugs

2

Description
Control group: Placebo in the control group contains starch corn which is provided in capsules and boxes of the same intervention group at the school of Pharmacy of Shahid Behest university of Medical Sciences.The placebo is given one capsule every 12 hours for 60 days to volunteer patients with hypertension
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Special Clinic in Zanjan University of Medical Sciences
Full name of responsible person
Masumeh Abbasi
Street address
7Tired St.
City
Zanjan
Province
Zanjan
Postal code
4515777978
Phone
+98 24 3356 5333
Email
ahanghar@zums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Alireza Shoghli
Street address
Deputy of Research and Technology, San Jan University of Medical Sciences, Azadi Sq, Jomhour Islami Ave.Zanjan I
City
Zanjan
Province
Zanjan
Postal code
45154
Phone
+98 24 3342 0677
Email
shoghli@zums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan 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
Zanjan University of Medical Sciences
Full name of responsible person
Masume Abbasi
Position
Ph.D Student of Iranian Medicin
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Education and Treatment Center of ValiaSr, ValiaSr Sq. Zanjan
City
Zanjan
Province
Zanjan
Postal code
4515777978
Phone
+98 24 3377 0801
Email
abbasi1393@zums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Hassan Ahangar
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Special clinic in zanjan university of Medical Sciences
City
Zanjan
Province
Zanjan
Postal code
4518617384
Phone
+98 24 3356 5333
Email
ahanghar@zums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Masumeh Abbasi
Position
Assistant
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
In front of Asia insurance, Jomhuri Ave, Azadi Blvd
City
Zanjan
Province
Zanjan
Postal code
4518617384
Phone
+98 21 6689 3256
Fax
Email
abbasi1393@zums.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
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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