Protocol summary

Summary
Objective: study on efficacy of Vaccinium arctostaphylos (L.) fruit extract in the treatment of hyperlipidemic patients. Study population: hyperlipidemic patients coming to the Diabetes Clinic in Karaj. Sample size: 60 patients. Inclusion criteria: patients aged 20 to 60 years, patients with serum cholesterol level above 240 mg/dl, patients with serum triglyceride level above 240 mg/dl, patients recently diagnosed as hyperlipidemic, literate patients. Exclusion criteria: patients with serum cholesterol or triglyceride levels above 300 mg/dl, patients using other blood lipid lowering agents, patients with cardiac, renal, hepatic, hematological diseases, hypothyroidism, diabetes, tachycardia, vertigo and seizure, patients with a history of gallstones or gall bladder surgery, patients using estrogen, steroid, beta-blocker and thiazide, pregnant women, women planning pregnancy, breast-feeding women. The intervention: Caucasian whortleberry fruit extract is administered to a group of 30 patients at the dose of one 500 mg capsule every 8 hours for 2 months and placebo is administered to another group of 30 patients every 8 hours for 2 months. At the end of the study, the blood lipids levels in the drug group and the placebo group are determined and compared with each other. Primary outcomes: Blood serum level of cholesterol, blood serum level of triglyceride.

General information

Acronym
SEVAFETHP
IRCT registration information
IRCT registration number: IRCT201112242288N4
Registration date: 2011-12-28, 1390/10/07
Registration timing: prospective

Last update:
Update count: 0
Registration date
2011-12-28, 1390/10/07
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
Research Institute for Islamic and Complementary Medicine
Expected recruitment start date
2012-01-21, 1390/11/01
Expected recruitment end date
2013-01-20, 1391/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study on Efficacy of Vaccinium arctostaphylos (L.) Fruit Extract in Treatment of Hyperlipidemic Patients
Public title
Study on efficacy of Caucasian whortleberry in the treatment of hyperlipidemic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients aged 20 to 60 years, patients with serum cholesterol level above 240 mg/dl, patients with serum triglyceride level above 240 mg/dl, patients recently diagnosed as hyperlipidemic, literate patients. Exclusion criteria: patients with serum cholesterol or triglyceride levels above 300 mg/dl, patients using other blood lipid lowering agents, patients with cardiac, renal, hepatic, hematological diseases, hypothyroidism, diabetes, tachycardia, vertigo and seizure, patients with a history of gallstones or gall bladder surgery, patients using estrogen, steroid, beta-blocker and thiazide, pregnant women, women planning pregnancy, breast-feeding women.
Age
From 20 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 60
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
Ethics Committee of 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
2011-10-08, 1390/07/16
Ethics committee reference number
89

Health conditions studied

1

Description of health condition studied
Hyperlipidemia
ICD-10 code
E78.5
ICD-10 code description
Hyperlipidemia, unspecified

Primary outcomes

1

Description
Blood serum cholesterol level of patients
Timepoint
2 months
Method of measurement
Medical laboratory (kit)

2

Description
Blood serum triglyceride level of patients
Timepoint
2 months
Method of measurement
Medical laboratory (kit)

Secondary outcomes

1

Description
Blood serum LDL cholesterol level of patients
Timepoint
2 months
Method of measurement
Medical laboratory (kit)

2

Description
Blood serum HDL cholesterol level of patients
Timepoint
2 months
Method of measurement
Medical laboratory (kit)

3

Description
Blood serum creatinine level of patients
Timepoint
2 months
Method of measurement
Medical laboratory (kit)

4

Description
Blood serum SGOT level of patients
Timepoint
2 months
Method of measurement
Medical laboratory (kit)

5

Description
Blood serum SGPT level of patients
Timepoint
2 months
Method of measurement
Medical laboratory (kit)

Intervention groups

1

Description
Caucasian whortleberry fruit extract is administered to a group of about 30 patients at the dose of one 500 mg capsule every 8 hours for 2 months.
Category
Treatment - Drugs

2

Description
One placebo capsule is administered to another group of about 30 patients every 8 hours for 2 months
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Clinic of diabetes
Full name of responsible person
Dr. Behrouz Abasi Alaee
Street address
Number 448, Street Bareghan, Square Azadegan
City
Karaj

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Institute for Islamic and Complementary Medicine
Full name of responsible person
Dr. Dabaghian
Street address
Number 9, Pirnia Alley, Lalehzar Shomali Street, Jomhoori Eslami Avenue
City
Tehran
Grant name
702
Grant code / Reference number
702
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
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
Institute of Medicinal Plants affiliated with the ACECR
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, Research Complex of the ACECR, End of Kavosh Boulevard, Kavosh Research Town, 55th Kilometer of Tehran-Gazvin Freeway
City
Karaj
Postal code
2378965473
Phone
+98 26147640109
Fax
+98 26 1476 4021
Email
kianbakht@imp.ac.ir; skianbakht@gmail.com
Web page address
www.imp.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Institute of Medicinal Plants affiliated with the ACECR
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, Research Complex of the ACECR, End of Kavosh Boulevard, Kavosh Research Town, 55th Kilometer of Tehran-Gazvin Freeway
City
Karaj
Postal code
2378965473
Phone
+98 26147640109
Fax
+98 26 1476 4021
Email
kianbakht@imp.ac.ir; skianbakht@gmail.com
Web page address
www.imp.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Institute of Medicinal Plants affiliated with the ACECR
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, Research Complex of the ACECR, End of Kavosh Boulevard, Kavosh Research Town, 55th Kilometer of Tehran-Gazvin Freeway
City
Karaj
Postal code
2378965473
Phone
+98 26147640109
Fax
+98 26 1476 4021
Email
kianbakht@imp.ac.ir; skianbakht@gmail.com
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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