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The Effect of The Jujuba And Thyme on Primery Hypertension

Protocol summary

Summary
Effect of jujube and thyme on essential hypertension (2) Design: Drug and placebo will be given to cross for 2 months in 36 patients participating in the study in age range 30 to 75 years is prescribed. (3) How to do: the patients divid into two groups of 18 persons. First, 10 mg of drug twice daily will be give to a group of patients and the other group will be give 10 mg of placebos group daily for 2 months. During the project once every two weeks blood pressure will be measured.(4) participants: 24 women and men in the age range 30 to 70 years old and the first and second stages of developing hypertension who referred to special clinics of Zanjan University of Medical Sciences and without conditions such as secondary hypertension, signs of organ damage at the end of the 6 months prior to the study, a sudden increase in blood pressure over 15 mm Hg, patient's blood pressure greater than or equal to 180/110 mm Hg, a variety of cardiac arrhythmias, diseases symptomatic valvular heart disease, impaired liver function, pregnancy or breast-feeding (5) interventions: drug and placebo (6) The main outcome variables : Mezaj ,Height,Weight, Age, Sex, Marital status, Occupation, etc. are also investigated

General information

Acronym
-
IRCT registration information
IRCT registration number: IRCT2015031821512N1
Registration date: 2016-01-17, 1394/10/27
Registration timing: prospective

Last update:
Update count: 0
Registration date
2016-01-17, 1394/10/27
Registrant information
Name
Davoud Hasani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3347 4788
Email address
davoud.hasani@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
vice Channcellor for research, Zanjan University of Medical Sciences
Expected recruitment start date
2016-04-02, 1395/01/14
Expected recruitment end date
2016-10-26, 1395/08/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of The Jujuba And Thyme on Primery Hypertension
Public title
The First Clinical Trial Of A Combination of Traditional Medicine in Primery Hypertension
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: All women and men in the age range 30 to 75 years old in the first and second primary hypertension clinic University of Medical Sciences with stakeholders, especially not out of the study. Exclusion criteria: Severe hypertension, hypertensive secondary, signs of organ damage at the end of the 6 months prior to the study, a sudden increase in blood pressure over 15 mm Hg; patient's blood pressure greater than or equal to 110 to 180 mm Hg, a variety of cardiac arrhythmias, valvular disease symptomatic heart disease, impaired liver function, pregnancy or lactation, serum potassium more than 5.5 or less than 5.3 equivalent in business l First, any disruption (medical or surgical) that, the researcher could interfere with the study, drugs interfering with hypertension, psychiatric disorders such as anxiety, depression and obsessive-compulsive or psychiatric drugs
Age
From 30 years old to 70 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size: 36
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
In this study will be used Table of random numbers.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Zanjan University of Medical Sciences
Street address
Azadi Ave. Zanjan University of Medical Sciences. zanjan,Iran
City
Zanjan
Postal code
4515613191
Approval date
2015-12-01, 1394/09/10
Ethics committee reference number
ZUMS.REC.1394.231

Health conditions studied

1

Description of health condition studied
Primery hypertention
ICD-10 code
I 10
ICD-10 code description
Primery hypertention

Primary outcomes

1

Description
primery hypertention
Timepoint
1/2weak
Method of measurement
Measuring Devices

Secondary outcomes

1

Description
Meezaj
Timepoint
Baseline
Method of measurement
questionnaire

Intervention groups

1

Description
Intervention Groups: Standardized drug, which is called jujube syrup, made in Pharmaceutics laboratory of Beheshti University of Medical Sciences will be given to 18 patients participating in the project for a period of 2 months to 5 ml twice daily(10mL total daily|). The concentration of combine is 30% and it is mixed of jujube and thyme and its based on jujube .
Category
Treatment - Drugs

2

Description
Control group: standardized placebo will be given to 18 patients participating in the project for a period of 2 months to 10 mL twice daily and fortnightly data measured blood pressure in patients.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Special clinic in Zanjan University of Medical Sciences
Full name of responsible person
Dr Davoud hasani
Street address
7 Tir st., Zanjan.Iran
City
Zanjan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Channcellor for Rresearch, Zanjan University of Medical Sciences
Full name of responsible person
Professor Soghrat Faghihzadeh
Street address
Azadi Ave.,Zanjan University of Medical Sciences,Zanjan, Iran
City
Zanjan University of Medical Sciences
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Channcellor for Rresearch, Zanjan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr Davoud Hasani
Position
PhD student of traditional medicine
Other areas of specialty/work
Street address
zanjan University of Medical Sciences
City
Zanjan
Postal code
4515613191
Phone
+98 24 3342 4771
Fax
+98 24 3342 4770
Email
davoud.hasani@zums.ac.ir
Web page address
WWW.ZUMS.AC.IR

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr Hassan Ahangar
Position
Professor of Cardiology
Other areas of specialty/work
Street address
7tir st.,Zanjan, Iran
City
Special clinic University of Medical Sciences
Postal code
4515613191
Phone
+98 24 3344 0302
Fax
Email
ahangarhassan@yahoo.com
Web page address
WWW.ZUMS.AC.IR

Person responsible for updating data

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr Davoud Hasani
Position
Student of Assistant Traditional Medicine
Other areas of specialty/work
Street address
Valiasr Hospital ,Zanjan, Iran
City
Zanjan
Postal code
4515613191
Phone
+98 24 3342 2210
Fax
+98 24 3336 4970
Email
davoud.hasani@ZUMS.ac.ir
Web page address
WWW.ZUMS.AC.IR

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
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