Comparison of effect of Amla (Emblica officinalis) with placebo in systolic and diastolic blood pressure in patients with primary hypertension
Design
Seventy patients with mild primary hypertension and meet inclusion criteria, randomly assigned to two groups which are used Amla or placebo together with their previous drugs.
Settings and conduct
The study is conducted in the clinic of hypertension of Heart Research Center of Tabriz University of Medical Sciences. ِDue to allocation concealment and the similar appearance of Amla and placebo capsules, investigator, participants, and analyzer are blind to the type of interventions.
Participants/Inclusion and exclusion criteria
Patients with mild primary hypertension taking up to two antihypertensive drugs who do not have any hypertensive complications.
Intervention groups
Amla capsule (500 mg powder of dried fruit) 3 times/day after meal
Main outcome variables
Systolic blood pressure; diastolic blood pressure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090527001957N7
Registration date:2018-03-23, 1397/01/03
Registration timing:registered_while_recruiting
Last update:2018-03-23, 1397/01/03
Update count:0
Registration date
2018-03-23, 1397/01/03
Registrant information
Name
Fataneh Hashem Dabaghian
Name of organization / entity
Research Institute for Islamic and Complementary Medicine
Country
Iran (Islamic Republic of)
Phone
+98 21 3395 0152
Email address
fatanehdabaghian@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-10-01, 1396/07/09
Expected recruitment end date
2018-10-01, 1397/07/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the hypotensive effect of amla ( Emblica officinalis) and placebo in patients with essential hypertension
Public title
hypotensive effect of amla ( Emblica officinalis)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
SBP>=140 mmHg
SBP>=150 mmHg in 60 year old or older patients
DBP>=90 mmHg
Exclusion criteria:
SBP>180 mmHg
DBP>110 mmHg
secondary hypertension
hypertensive encephalopathy
Hypertensive retinopathy grade 3,4
Acute cerebrovascular accident
Acute coronary syndrome
decompensated congestive heart failure
creatinin > 1.5 times more than normal limit
ALT> 3 times more than normal limit
diabetic complications
coagulopathy
use of anticoagulants and anti platelet drugs
use of NSAIDS
platelet<100000
Age
From 18 years old to 80 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization is used and blocks are selected randomly using the table of random numbers. Allocation concealment will be carried out using Sealed envelops.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Amla and placebo are prepared in similar capsules, therefore participants during the trial, data collectors, outcome assessors, analyzer and manuscript writers are blind.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Junction of Sheikh Fazlollah and Himmat freeway, next to Milad tower, Iran Unuiversity of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1145847111
Approval date
2016-12-10, 1395/09/20
Ethics committee reference number
IR.IUMS.REC 1395.95-02-116-29004
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
systolic blood pressure
Timepoint
before the intervention, at the end of the first and second month after intervention
Method of measurement
mercury barometer
2
Description
diastolic blood pressure
Timepoint
before the intervention, at the end of the first and second month after intervention
Method of measurement
mercury barometer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Amla capsule( 500 mg) 3 times/day after meal
Category
Treatment - Drugs
2
Description
Control group: placebo capsul 3 times /day after meal
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Madani Heart Center
Full name of responsible person
Samad Ghaffari
Street address
Daneshgah St., Shahid Madani hospital, Heart research center
City
Tabriz
Province
East Azarbaijan
Postal code
1145847111
Phone
+98 41 3337 3958
Email
ghafaris@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Institute for Islamic and Complementary Medicine
Full name of responsible person
Ali Ghobadi
Street address
No: 9, Pirnia alley, Lalehzar St., Jomhuri Ave., Tehran
City
Tehran
Province
Tehran
Postal code
1145847111
Phone
+98 21 3345 0154
Email
alighobadi56@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Institute for Islamic and Complementary Medicine
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
Research Institute for Islamic and Complementary Medicine
Full name of responsible person
Fataneh Hashem-Dabaghian
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Community medicine
Street address
No: 9, Pirnia alley, Lalehzar St., Jomhuri Ave., Tehran
City
Tehran
Province
Tehran
Postal code
1145847111
Phone
+98 21 3395 0154
Email
fataneh.dabaghian@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Research Institute for Islamic and Complementary Medicine
Full name of responsible person
Fataneh Hashem-Dabaghian
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
community medicine
Street address
No: 9, Pirnia alley, Lalehzar St., Homhuri Ave., Tehran
City
Tehran
Province
Tehran
Postal code
1145847111
Phone
+98 21 3395 0154
Email
fataneh.dabaghian@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Research Institute for Islamic and Complementary Medicine
Full name of responsible person
Fataneh Hashem-Dabaghian
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
community medicine
Street address
No: 9, Pirnia alley, Lalehzar St., Jomhuri Ave., Tehran
City
Tehran
Province
Tehran
Postal code
1145847111
Phone
+98 21 3395 0154
Email
fataneh.dabaghian@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Collected data can be shared without the name and characteristics of the participants.
When the data will become available and for how long
Access to data is possible 6 months after the publication of the article
To whom data/document is available
Data will only be available to researchers in academic institutions
Under which criteria data/document could be used
There is no limit to the data analysis
From where data/document is obtainable
Applicants can email to the following address:
fataneh.dabaghian@yahoo.com
What processes are involved for a request to access data/document