Background and introduction: A recent report published by the World Health Organization on the importance of chronic diseases including hypertension as a deterrent factor of countries access to appropriate health status has been emphasized. Objectives: Determines the effects of reform temperament (Mizaj) and wet-cupping for treating persistent hypertension. Inclusion criteria included: Hypertension; age 30-60 years; Not having a history of chronic disease such as diabetes and kidney; to do not have reform temperament or wet-cupping for 1 years ago. Exclusion criteria included: Experience unpleasant and serious accidents, such as relatives died in the past 6 months; females become pregnant during the study; current treatment with other complementary treatments. In total, 189patients aged 30-60 years with hypertension; 126were randomly assigned to experimental (63patients in wet-cupping and 63patients in reform temperament) and 63to the control group. Patients in the experimental group were offered usual care and also reform temperament or wet-cupping and the control group received usual care. Three outcomes assessed at baseline and again 45 days following start intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138905114495N1
Registration date:2011-06-22, 1390/04/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-06-22, 1390/04/01
Registrant information
Name
Mohammad Zarei
Name of organization / entity
Islamic Azad University Quchan Branch
Country
Iran (Islamic Republic of)
Phone
+98 58 1220 1210
Email address
m.zarei@iauq.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Islamic Azad University Tehran Medical Branch
Expected recruitment start date
2011-05-05, 1390/02/15
Expected recruitment end date
2011-06-21, 1390/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison efficacy of wet-cupping and reform temperament for decrease blood pressure of patient with hypertension
Public title
Comparison efficacy of wet-cupping and reform temperament for decrease blood pressure of patient with hypertension
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria included: Hypertension; age 30-60 years; not having a history of chronic disease such as diabetes and kidney; to do not have reform temperament or wet-cupping for 1 years ago. Exclusion criteria included: Experience unpleasant and serious accidents, such as relatives died in the past 6 months; females become pregnant during the study; current treatment with other complementary treatments.
Age
From 30 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
51
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Islamic Azad University Tehran Medical Branch
Street address
Nursing College, Islamic Azad University Tehran Medical Branch, Khagani St. , Shariati St.
City
Tehran
Postal code
193951495
Approval date
2011-04-25, 1390/02/05
Ethics committee reference number
901-1003
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
Before intervention and every 2 weeks until 45 days after intervention
Method of measurement
Per mmHg with mercury sphygmomanometer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1 : Drug therapy and plus wet-cupping. Drug therapy continued base on according to cardiologist for patient and researcher didn't have any intervention in drug therapy and only recorded their. Researcher did wet-cupping (three times with 2 weeks interval) in addition drug therapy.
Category
Treatment - Other
2
Description
Intervention group 2 : Drug therapy and plus reform temperament. Drug therapy continued base on according to cardiologist for patient and researcher didn't have any intervention in drug therapy and only recorded their. Researcher did reform temperament with prescribe proper diet base on type temperament (Mizaj).
Category
Treatment - Other
3
Description
Control group: Drug therapy. Drug therapy continued base on according to cardiologist for patient and researcher didn't have any intervention in drug therapy and only recorded their.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Hosein (A) Clinic
Full name of responsible person
Dr. Seyed Ali Javadi
Street address
Goharshad St. , Shahid Motahari St.
City
Quchan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Islamic Azad University Tehran Medical Branch
Full name of responsible person
Seyed Alireza Najafi
Street address
Vice chancellor for research, Islamic Azad University Tehran Medical Branch, Khagani St. , Shariati St.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Islamic Azad University Tehran Medical Branch
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
Islamic Azad University Tehran Medical Branch
Full name of responsible person
Mohammad Zarei
Position
Student of MSN
Other areas of specialty/work
Street address
No.177, Hafez 5 St.
City
Quchan
Postal code
9471636581
Phone
+98 58 1224 1029
Fax
+98 58 1223 5031
Email
m.zarei51@yahoo.com; m.zarei@iauq.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University Tehran Medical Branch
Full name of responsible person
ُShirin Hejazi
Position
MSN
Other areas of specialty/work
Street address
Nursing Department, Islamic Azad University Tehran Medical Branch, Khagani St. Shriati St.
City
Tehran
Postal code
193951495
Phone
+98 21 2261 8515
Fax
+98 21 2261 8515
Email
shi_hej@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University Tehran Medical Branch
Full name of responsible person
Mohammad Zarei
Position
Student of MSN
Other areas of specialty/work
Street address
No.177, Hafez 5
City
Quchan
Postal code
9471636581
Phone
+98 58 1224 1029
Fax
+98 58 1223 5031
Email
m.zarei51@yahoo.com; m.zarei@iauq.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)