In this double-blind randomized controlled trial, patients with uncontrolled hypertension (blood pressure equal to or more than 110/80 mmHg) who are under treatment with 50 mg Losartan and presented to the cardiology clinics of Zanjan University of Medical Sciences and met our criteria will be included. The calculated sample size for this study is 40 patients in total (two groups with 20 individuals each). After recording the baseline demographic and clinical characteristics of the patients, particularly the baseline blood pressure and performing the routine blood tests, the patients will be randomized to receive either Aloevera extract (250 mg capsules daily for 8 weeks) or placebo. Before the initiation of the experiment, the individual’s constitutional nature of the patients will be evaluated using a questionnaire and will be checked up by three traditional medicine specialists. Every 2 weeks the patients will be visited for the measurement of the blood pressure and will be checked for the development of any side effects and the effect of the treatment on their constitutional nature. Finally, the changes of blood pressure will be compared between the study groups and we will decide about the effect of Aloevera on the blood pressure of the patients. Primary outcome of the study is the change in the blood pressure.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016040827276N1
Registration date:2016-06-02, 1395/03/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-06-02, 1395/03/13
Registrant information
Name
Anahita Heidari
Name of organization / entity
Zanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 24 3344 0301
Email address
doc.heidari@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Zanjan University of Medical Sciences
Expected recruitment start date
2016-04-19, 1395/01/31
Expected recruitment end date
2017-03-20, 1395/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of “Aloe vera” on the control of essential hypertension in patients under treatment with Losartan; a double-blind randomized clinical trial
Public title
The effect of “Aloe vera” on the control of essential hypertension
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria
All women and men; presenting with uncontrolled hypertension who present to the cardiology clinics affiliated to the Zanjan University of Medical Sciences; aged 30-70; with systolic blood pressure greater than or equal to 140 and diastolic blood pressure greater than or equal to 90 mg; using 50 mg losartan for at least 6 weeks.
Exclusion Criteria:
hypertension, greater than or equal to 180/110 mgHg which needs multi-drug treatment or emergency injection to control the blood pressure; Diagnosis of secondary blood pressure, e.g. Hyperaldosteronism, pheochromocytoma, Cushing syndrome, renal artery stenosis; Symptoms of End organ damage such as renal failure, congestion heart failure, myocardial infraction, cerebrovascular incidences within six months before the research starts; Sudden increase in blood pressure greater than 15mmHg in any time during the research (necessary to mention, if with increase lesser than 15 mmHg the blood pressure of the case is greater than or equal to 180/110 mmHg, he will be discarded from the study and, then, will be referred to a cardio-vascular specialist); Various Heart arrhythmias (such as blocks grades 2 and 3); Symptomatic heart valve diseases (except Mitral Valve prolapse); Renal or hepatic failure (Liver cirrhosis, Chronic active Hepatitis or autoimmune Hepatitis); Pregnancy and breastfeeding; Serum Potassium greater than 5 or less than 3.5 meq/L in the first visit; Any sort of disorder/failure (either medical or surgical), from researcher’s point of view, which can intervene the research; Taking drugs that influence blood pressure such as NSAIDs, CORTICOSTEROIDs, Oral contraceptives; Psychological disorders such as anxiety, depression, obsession, or taking Psychiatric drugs
Age
From 30 years old to 70 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
zanjan medical university
Street address
medical univesity - zanjan
City
zanjan
Postal code
Approval date
2016-04-12, 1395/01/24
Ethics committee reference number
ZUMS.REC.1395.21
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
one baselinemeasurement and 4 times follow up measurement every 2 weaks
Method of measurement
mmHg with sphygomanometer
Secondary outcomes
empty
Intervention groups
1
Description
Capsules containing aloe vera extract for 8 weeks
Category
Treatment - Drugs
2
Description
Capsules containing 250 mg Lactose for 8 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Cardiology clinics affiliated to Zanjan university of medical science
Full name of responsible person
Anahita Heidari
Street address
Ayatollah Mousavi educational &treatment center, gavazang road zanjan
City
Zanjan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Science
Full name of responsible person
Dr. Soghrat Faghihzadeh
Street address
Headquarter of medical science,deputy research & technology, Jomhori street, Azadi sq, Zanjan
City
Zanjan
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 Science
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
Anahita Heidari
Position
PhD student of traditional medicine
Other areas of specialty/work
Street address
Valiasr medical education center , after Valiasr sq, Zanjan
City
Zanjan
Postal code
Phone
+98 24 17124
Fax
Email
Doc.heidari@zums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr. Hasan Ahangar
Position
Cardiologist
Other areas of specialty/work
Street address
clinical education center of moosavi,gavazang road,zanjan
City
Zanjan
Postal code
Phone
+98 24331330000
Fax
Email
hassanahangar@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Anahita Heidari
Position
PhD student of traditional medicine
Other areas of specialty/work
Street address
clinical education center of valiasar,above valiasr sq,zanjan
City
Zanjan
Postal code
Phone
+98 24 17124
Fax
Email
doc.heidari@zums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)