The aim of this study is investigating the effect of Onopordon Acanthium seed on primary hypertension reduction in patients under treatment by losartan. The statistical sample of the study includes 20-25 patients aged 30-60 suffering from primary hypertension in Imam Khomeini Hospital or Amir-Alam Hospital of Tehran University of Medical Sciences who are under treatment by Losartan but still their blood pressure is greater than or equal to 140/90 mmHg. These patients must not have a background of malignant hypertension, heart disease. They also must not suffer from side effects of end organ disorder due to blood pressure increase. The patients take 50 mg Losartan on a daily basis. In addition to 4 capsules containing Onopordon Acanthium extract for two months. Patients are visited every two weeks. At the end of two months, data will be recorded and analysed at the end of the research.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013020712391N1
Registration date:2013-04-14, 1392/01/25
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-04-14, 1392/01/25
Registrant information
Name
Roshanak Ghods
Name of organization / entity
Tehran University of Medical Sciences - Faculty of Traditional Medicine
Country
Iran (Islamic Republic of)
Phone
+98 21 7750 4066
Email address
ghods.r@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2013-02-19, 1391/12/01
Expected recruitment end date
2013-10-23, 1392/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the Effect of Onopordon Acanthium Seed on Primary Hypertension Reduction in Patients under Treatment by Losartan
Public title
Investigating the Effect of Onopordon Acanthium Seed on Primary Hypertension Reduction in Patients under Treatment by Losartan
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Aged between 30 and 60; SBP>= 140; DBP >= 90 mmHg; Patient under treatment by Losartan (50 mg); Exclusion Criteria: Existence of malignant hypertension, i.e. blood pressure higher than 200/140 mmHg which needs multi-drug treatment or emergency IV drug infusion to control blood pressure; History of secondary hypertension ; Existence of end organ damages (EOD); Sudden increase of blood pressure to greater than 15 mmHg at any time during the study; Existence of any kind of cardiac arrhythmias; Symptomatic valvular heart diseases (except mitral valve prolapse); Liver function disorders; Pregnancy and lactation; Cured or uncured malignancy during the last 5 years; Serum potassium >5.2 or <3.5 mEq/L in the first visit; Drug or alcohol usage background; Any kind of disorder (medical or surgical) which can interfere the study
Age
From 30 years old to 60 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
25
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Institue for Islamic and Complementary Medicine
Street address
No. 9, First Pirnia Allay, North Lale-zaar St. Jomhoori Eslami St., Tehran
City
Tehran
Postal code
Approval date
2012-10-09, 1391/07/18
Ethics committee reference number
732/ط/م/26پ
Health conditions studied
1
Description of health condition studied
Primary hypertension
ICD-10 code
I10
ICD-10 code description
Essential (primary) hypertension
Primary outcomes
1
Description
Systolic Blood Pressure
Timepoint
Beginning of the project, End of the second week, end of the fourth week, end of the sixth week, end of the eighth week
Method of measurement
Measuring by mercury sphygmomanometer in millimetres of mercury (mmHg)
2
Description
Diastolic Blood Pressure
Timepoint
Beginning of the project, End of the second week, end of the fourth week, end of the sixth week, end of the eighth week
Method of measurement
Measuring by mercury sphygmomanometer in millimetres of mercury (mmHg)
Secondary outcomes
empty
Intervention groups
1
Description
All patients in interfering group take 50mg Losartan and also a capsule containing Onopordon Acanthium seeds extract orally once a day.
Category
Treatment - Drugs
2
Description
All patients in control group, take 50mg Losartan and also placebo which is designed this study orally once a day.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Dr. Manoochehr Gharooni
Street address
Angiography section, Imam Khomeini Hospital, Keshavarz Blvd., Tehran
City
Tehran
2
Recruitment center
Name of recruitment center
Amir Alam Hospital
Full name of responsible person
Dr. Manoochehr Gharooni
Street address
C.C.U. Section, Amir-Alam Hospital, Sa'di St., Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dariush Mahmoodi
Street address
Office of Vice Chancellor for Research, Third floor, Faculty of Traditional Medicine, Behesht St., Vahdat Eslami St. (South Hafiz), Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
Traditional Medicine and Pharmacy Research Center
Full name of responsible person
Dr.Tahmineh Akbarzade
Street address
Traditional Medicine and Pharmacy Research Center,Tehran University of Medical Sciences,Tehran,Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Traditional Medicine and Pharmacy Research Center
Proportion provided by this source
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
Tehran University of Medical Sciences
Full name of responsible person
Dr.Roshanak Ghods
Position
Phd candidate
Other areas of specialty/work
Street address
Behesht Clinic, Behesht St., Vahdat-e Eslami st. (South Hafiz), Tehran
City
Tehran
Postal code
Phone
+98 21 7750 4066
Fax
Email
ghods_r@razi.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Manoochehr Gharooni
Position
Cardiologist
Other areas of specialty/work
Street address
C.C.U. Section, Amir-Alam Hospital, Sadi St., Tehran
City
Tehran
Postal code
Phone
+98 21 6670 4136
Fax
Email
d_m_garooni@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr.Roshanak Ghods
Position
Phd candidate
Other areas of specialty/work
Street address
Behesht Clinic, Behesht St., Vahdat-e Eslami St. (South Hafiz), Tehran
City
Tehran
Postal code
Phone
+98 21 7750 4066
Fax
Email
ghods_r@razi.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)