Protocol summary

Summary
Objectives: control of essential hypertension with captophyte and assess the pharmacogenomics of it. Design: a randomized controlled trial is designed. Setting & conduct: Patients with primary diagnosis of essential hypertension, and after obtaining informed written consent, 10 ml of blood is taken for serum chemistry including (TG, Chol, LDL, HDL, beta carotene) and molecular studies (expression of ACE, ACE2, AGTR, AGTR2, AGT, NOS3 and genotyping for single nucleopeptide polymorphysms of rs1799752 ,rs2106809, rs5186 ,rs699 , rs1799983) are supplied with Captophyte. Inclusion criteria: essential hypertension; age of 20 - 55 years and no response to diet and exercise in pre hypertension state. Exclusion criteria: one or more of the following: Creatinine levels > 1.5 mg/dl; elevated liver enzymes; intake of any of the anti-hypertensive medications due any other underlying medical causes; concurrent intake of any medications having hepatic metabolism (with super enzymes of cytochrome p450 including CYP2D6 (i.e. imipramine, fluoxetine, and … ). CYP3A4 (clarythromycin, erythromycin, cimetidine, and …) which metabolize most of BB, CCB, ACEI, ARB; medication with warfarin; other cardiovascular complications such as angina pectoris, IHD, hypertensive crisis, or cerebrovascular accidents such as TIA, or stroke which require CCB, BB, ACE; GI disturbances; allergic reactions; immunologic reactions; unwillingness to participate in the study; death of the patient. Captophyte (2.025 g) is administered three times daily in the control group and Captopril 25 mg three times daily combined with placebo is supplied to control group. The patients are followed up weekly. Main outcome is determined by change in blood pressure.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015020110326N2
Registration date: 2015-09-25, 1394/07/03
Registration timing: prospective

Last update:
Update count: 0
Registration date
2015-09-25, 1394/07/03
Registrant information
Name
Tasnim Eghbal Eftekhaari
Name of organization / entity
Hormozgan University of Medical Sciences, Department of Resaerch and Technology
Country
Iran (Islamic Republic of)
Phone
+98 76 1333 7192
Email address
teftekhari@hums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research & TechnologyHormozgan University of Medical Sciences
Expected recruitment start date
2015-10-01, 1394/07/09
Expected recruitment end date
2016-06-01, 1395/03/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of Captophyte compound in comparison with Captopril alone on blood pressure in patients with essential hypertension
Public title
Efficacy of Captophyte compound in comparison with Captopril alone on blood pressure in patients with essential hypertension
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: essential hypertension; age of 20 - 55 years and no response to diet and exercise in prehypertension state. Exclusion criteria: one or more of the following: Creatinine levels > 1.5 mg/dl; elevated liver enzymes; intake of any of the anti-hypertensive medications (nitrates, beta blockers, anhydrase carbonic inhibitors, calcium channel blockers, diuretics and angiotensin receptor blocker) due any other underlying medical causes; concurrent intake of any medications having hepatic metabolism (with super enzymes of cytochrome p450 including CYP2D6 (i.e. imipramine, fluoxetine, promethazine, celcoxib, hydroxyzine, citalopram, dextrometorphan, codeine, ondansetron, tamoxifen, tarmadol ). CYP3A4 (clarythromycin, erythromycin, cimetidine, carbamazepine, phenytoin, phenobarbital, rifampin, corticosteroids, atorvastatin, benzodiazepines, and haloperidol) which metabolize most of BB, CCB, ACEI, ARB; medication with warfarin; other cardiovascular complications such as angina pectoris, IHD, hypertensive crisis, or cerebrovascular accidents such as TIA, or stroke which require CCB, BB, ACE; GI disturbances; allergic reactions; immunologic reactions; unwillingness to participate in the study; death of the patient.
Age
From 20 years old to 55 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Random number generator table

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Hormozgan University Ethics Committee
Street address
Shahid Mohammadi hospital, Department of research & Technology, Ethics Committee
City
Bandar-e Abbas
Postal code
7919915519
Approval date
2015-08-25, 1394/06/03
Ethics committee reference number
3-HEC-94-6-3

Health conditions studied

1

Description of health condition studied
Essential Hypertesion
ICD-10 code
I10
ICD-10 code description
Essential (primary) hypertension

Primary outcomes

1

Description
Blood pressure
Timepoint
Every week for 28 days
Method of measurement
Measuring blood pressure with mercury sphygmomannometer

Secondary outcomes

empty

Intervention groups

1

Description
Intervention 1: Captophyte compound divided in two equal 2g doses of red algae and combined with captopril 25 mg tablets in a capsule (Captophyte capsule) three times daily for 28 days.
Category
Treatment - Drugs

2

Description
Control group: 25 mg captopril combined with placebo (from DANA pharmaceuticals) is used for 28 days
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Mohammadi Hospital
Full name of responsible person
Dr Hossein Farshidi
Street address
Cardiovascular Research Center, Shahid Mohammadi hospital, Jomhouri Blvd
City
Bandar-e Abbas

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research & Technology, Hormozgan University of Medical Sciences
Full name of responsible person
Dr Abdolazim Nejatizadeh
Street address
Shahid Mohammadi Hopsital, Department of research & technology, Jomhouri Blvd
City
Bandar-e Abbas
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 & Technology, Hormozgan 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
Hormozgan University of Medical Sciences
Full name of responsible person
Dr Seyedeh Tasnim Eghbal Eftekhaari
Position
PhD Candidate
Other areas of specialty/work
Street address
Molecular Medicine Research Center, Shahid Mohammdi Hospital, Jomhouri Blvd
City
Bandar-e Abbas
Postal code
7919915519
Phone
+98 76 3333 7192
Fax
+98 76 3333 7192
Email
teftekhari@hums.ac.ir; tasnim.eftekhaari@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hormozgan University of Medical Sciences,
Full name of responsible person
Dr Abdolazim Nejatizadeh
Position
Vice Chancellor for Research & Technology; Associate Professor of human genetics
Other areas of specialty/work
Street address
Department of Research & Technology, Shahid Mohammdi Hospital, Jomhouri Blvd
City
Bandar-e Abbas
Postal code
7919915519
Phone
+98 76 3333 7192
Fax
+98 76 3333 7192
Email
anejatizadeh@hums.ac.ir; azimnejate@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Hormozgan University of Medical Sceinces
Full name of responsible person
Dr Seyede Tasnim Eghbal Eftekhaari
Position
PhD Candidate
Other areas of specialty/work
Street address
Molecular Medicine Research Center,Departemnt of Research & Technology, Shahid Mohammadi Hospital, Jomhouri Blvd
City
Bandar-e Abbas
Postal code
7919915519
Phone
+98 76 3333 7192
Fax
+98 76 3333 7192
Email
teftekhari@hums.ac.ir; tasnim.eftekhaari@gmail.com
Web page address

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
empty
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