Protocol summary

Summary
Objective: Comparing the effects of Vaccinium arctostaphylos fruit extract on cardiometabolic indices with placebo in hypertensive obese patients. Study design: randomized, double-blind, placebo-controlled, two group parallel design, single-center, phase 2 of clinical trial. Study population: Hypertensive obese patients. Sample size: 100 patients. Inclusion criteria: Iranian male and female hypertensive obese outpatients; patients aged 30 to 80 years; patients with body mass index between 25 kilograms per square meter and 35 kilograms per square meter; patients with systolic blood pressures between 14 and 16 mmHg; patients with diastolic blood pressures between 8 and 10 mmHg; patients taking synthetic antihypertensive drugs with 2 different mechanisms. Exclusion criteria: Patients taking other drugs effective on the blood glucose and lipid levels and body weight; patients with cardiac, renal, hepatic, hematological diseases, hypothyroidism, tachycardia, vertigo and seizure; patients with a history of gallstones or gall bladder surgery; pregnant women; women planning pregnancy; breast-feeding women. Interventions: Vaccinium arctostaphylos fruit extract is administered at the dose of one 400 mg capsule every 8 hours to a group of 50 patients for 3 months and one placebo capsule is administered every 8 hours to another group of 50 patients for 3 months. Before intervention and 3 months after intervention, the primary and secondary outcome variables are evaluated. Primary outcome variables: Blood levels of glycosylated hemoglobin and LDL-C, amounts of systolic and diastolic blood pressures, body mass index, waist circumference. Secondary outcome variables: Blood levels of fasting glucose, total cholesterol, triglyceride, HDL-C, creatinine, SGOT and SGPT.

General information

Acronym
-
IRCT registration information
IRCT registration number: IRCT201710302288N12
Registration date: 2017-11-15, 1396/08/24
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-11-15, 1396/08/24
Registrant information
Name
Saeed Kianbakht
Name of organization / entity
Iranian Academic Center for Education, Culture and Research Institute of Medicinal Plants
Country
Iran (Islamic Republic of)
Phone
+98 26147640109
Email address
kianbakht@imp.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Research Institute for Islamic and Complementary Medicine
Expected recruitment start date
2017-06-22, 1396/04/01
Expected recruitment end date
2019-06-22, 1398/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial comparing the effects of Vaccinium arctostaphylos fruit extract with placebo on the blood levels of glycosylated hemoglobin and LDL-choletserol, amounts of systolic and diastolic blood pressures, body mass index and waist circumference in hypertensive obese patients
Public title
Effects of vaccinium arctostaphylos fruit on cardiometabolic indices in hypertensive obese patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Iranian male and female hypertensive obese outpatients; patients aged 30 to 80 years; patients with body mass index between 25 kilograms per square meter and 35 kilograms per square meter; patients with systolic blood pressures between 14 and 16 mmHg; patients with diastolic blood pressures between 8 and 10 mmHg; patients taking synthetic antihypertensive drugs with 2 different mechanisms. Exclusion criteria: Patients taking other drugs effective on the blood glucose and lipid levels and body weight; patients with cardiac, renal, hepatic, hematological diseases, hypothyroidism, tachycardia, vertigo and seizure; patients with a history of gallstones or gall bladder surgery; pregnant women; women planning pregnancy; breast-feeding women.
Age
From 30 years old to 80 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 100
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
Research Institute for Islamic and Complementary Medicine
Street address
Number 9, Pirnia Alley, Lalehzar Shomali Street, Jomhoori Eslami Avenue
City
Tehran
Postal code
1145847111
Approval date
2017-06-16, 1396/03/26
Ethics committee reference number
IR.IUMS.REC.1396.31591

Health conditions studied

1

Description of health condition studied
Obesity
ICD-10 code
E66.0
ICD-10 code description
Obesity due to excess calories

2

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

Primary outcomes

1

Description
Blood level of glycosylated hemoglobin
Timepoint
Before and after 3 months of intervention
Method of measurement
Kit

2

Description
Blood level of low density lipoprotein cholesterol
Timepoint
Before and after 3 months of intervention
Method of measurement
Kit

3

Description
Body mass index
Timepoint
Before and after 3 months of intervention
Method of measurement
Scale and tape measure

4

Description
Waist circumference
Timepoint
Before and after 3 months of intervention
Method of measurement
Tape measure

5

Description
Systolic blood pressure
Timepoint
Before and after 3 months of intervention
Method of measurement
24-hour ambulatory blood pressure monitoring

6

Description
Diastolic blood pressure
Timepoint
Before and after 3 months of intervention
Method of measurement
24-hour ambulatory blood pressure monitoring

Secondary outcomes

1

Description
Fasting blood glucose level
Timepoint
Before and after 3 months of intervention
Method of measurement
Kit

2

Description
Blood total choletserol level
Timepoint
Before and after 3 months of intervention
Method of measurement
Kit

3

Description
Blood triglyceride level
Timepoint
Before and after 3 months of intervention
Method of measurement
kit

4

Description
Blood high density lipoprotein cholesterlol level
Timepoint
Before and after 3 months of intervention
Method of measurement
Kit

5

Description
Blood serum glutamate oxaloacetate transaminase level
Timepoint
Before and after 3 months of intervention
Method of measurement
Kit

6

Description
Blood serum glutatamate pyruvate transaminase level
Timepoint
Before and after 3 months of intervention
Method of measurement
Kit

7

Description
Blood creatinine level
Timepoint
Before and after 3 months of intervention
Method of measurement
Kit

Intervention groups

1

Description
Vaccinium arctostaphylos fruit extract is administered at the dose of one 400 mg capsule every 8 hours to a group of 50 patients for 3 months
Category
Treatment - Drugs

2

Description
One placebo capsule is adminstered every 8 hours to a group of 50 patients for 3 months
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Baqiyatallah Hospital
Full name of responsible person
Dr. Reza Mohtashami
Street address
Molla Sadra street, Vanak square
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, Research Institute for Islamic and Complementary Medicine
Full name of responsible person
Dr. Fataneh Hashem Dabaghian
Street address
Number 9, Pirnia Alley, Lalehzar Shomali Street, Jomhoori Eslami Avenue
City
Tehran
Grant name
96-105-2937
Grant code / Reference number
96-105-2937
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Research Institute for Islamic and Complementary Medicine
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
ACECR Institute of Medicinal Plants
Full name of responsible person
Dr. Saeed Kianbakht
Position
Ph.D. in pharmacology, assistant professor of the department of pharmacology and applied medicine in
Other areas of specialty/work
Street address
Institute of Medicinal Plants, ACECR Complex, Supa Boulevard, Poleh Kordan
City
Karaj
Postal code
3365166571
Phone
+98 26 3476 4010
Fax
+98 26 3476 4021
Email
skianbakht@yahoo.com; kianbakht@imp.ac.ir
Web page address
www.imp.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
ACECR Institute of Medicinal Plants
Full name of responsible person
Dr. Saeed Kianbakht
Position
Ph.D. in pharmacology, assistant professor of the department of pharmacology and applied medicine in
Other areas of specialty/work
Street address
Institute of Medicinal Plants, ACECR Complex, Supa Boulevard, Poleh Kordan
City
Karaj
Postal code
3365166571
Phone
+98 26 3476 4010
Fax
+98 26 3476 4021
Email
skianbakht@yahoo.com; kianbakht@imp.ac.ir
Web page address
www.imp.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
ACECR Institute of Medicinal Plants
Full name of responsible person
Dr. Saeed Kianbakht
Position
Ph.D. in pharmacology, assistant professor of the department of pharmacology and applied medicine in
Other areas of specialty/work
Street address
Institute of Medicinal Plants, ACECR Complex, Supa Boulevard, Poleh Kordan
City
Karaj
Postal code
3365166571
Phone
+98 26 3476 4010
Fax
+98 26 3476 4021
Email
skianbakht@yahoo.com; kianbakht@imp.ac.ir
Web page address
www.imp.ac.ir

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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