Study: Adolescent between 12 to 18 years old with dyslipidemic features randomly divided into groups of control and case. Each group has 36 members. Control group get placebo and case group get Hibiscus sabdariffa powder. Hibiscus sabdariffa calyx powder in 2 gr sachets was used three times a day by patients for one month. Each patient was bled two times; first at the beginning before entrancing study and second at the end of study. One month after consumption of drug and placebo by case and control group respectively, laboratory parameters like TG, TC, LDL and HDL was measured by auto analyzer method
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201109122306N2
Registration date:2011-12-28, 1390/10/07
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-12-28, 1390/10/07
Registrant information
Name
Ali Mohammad Sabzghabaee
Name of organization / entity
Isfahan university of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 7070
Email address
sabzghaba@pharm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences.
Expected recruitment start date
2011-05-05, 1390/02/15
Expected recruitment end date
2011-12-06, 1390/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical evaluation of Hibiscus sabdariffa L. in comparision with placebo on treatment of dyslipidemia in adolescents between 12-18 years old
Public title
Preliminary clinical evaluation of Hibiscus sabdariffa L.calyx on treatment of dyslipidemia in adolescents
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
1)adolescents between 12 to 18 years old that have at least one of these criteria:
a: triglyceride more than 90 percentile b: total cholesterol more than 90 percentile c: LDL more than 90 percentile d:HDL less than 10 percentile
2) Not using tobacco
3) No history of alcohol consumption or drug abuse
4) No history of metabolic diseases like diabetes, thyroid gland dysfunction, nephrotic syndrome, chronic pancreatitis, liver and gall bladder diseases that affects lipid profiles
5) Not using drugs which affect lipid profiles like statins and hormonal pills like estrogens, progestrones and oral contraceptives.
Exclusion criteria:
1) Lack of patient’s compliance with drug regimens at least for one week.
2) Pregnancy and lactation
3) Drug sensitivity
4) Suffering from any diseases which interact with lipid profiles
5) Intake of any kind of drugs or other compounds lowering lipid profile like corticosteroids, androgens, estrogenes, progestines, thiazides, beta blockers and thyroid hormones
Age
From 12 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences.
Street address
Vice chancellor for research, Isfahan University of Medical Sciences, Isfahan
City
Isfahan
Postal code
Approval date
2010-01-02, 1388/10/12
Ethics committee reference number
388590
Health conditions studied
1
Description of health condition studied
Dyslipidemia
ICD-10 code
E78.5
ICD-10 code description
Hyperlipidaemia,unspecified
Primary outcomes
1
Description
LDL Cholestrol
Timepoint
Before intervention, one month after intervention
Method of measurement
mg/dl through using laboratory kit
2
Description
HDL Cholestrol
Timepoint
Before intervention, one month after intervention
Method of measurement
mg/dl through using laboratory kit
3
Description
Triglyceride
Timepoint
Before intervention, one month after intervention
Method of measurement
mg/dl through using laboratory kit
4
Description
Total cholestrol
Timepoint
Before intervention, one month after intervention
Method of measurement
mg/dl through using laboratory kit
Secondary outcomes
empty
Intervention groups
1
Description
Hibiscus sabdariffa L. calices powdered and packed in 2 gr sachets. Each patient consumed 3 sachets per day during one month.
Category
Treatment - Drugs
2
Description
Placebo powder packed in 2 gr sachets and each patient consumed 3 sachets per day during one month.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Sedighe Tahere,Isfahan cardiovascular research center
Full name of responsible person
Street address
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Isfahan University of Medical Sciences
Full name of responsible person
Dr. Peyman Adibi
Street address
Isfahan University of Medical Sciences, Daneshgah st. beginning, Azadi sq.Isfahan
City
Isfahan
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, Isfahan 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
Isfahan University of Medical Sciences
Full name of responsible person
Ehsan Ataei
Position
Student of pharmacy
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Daneshgah st. beginning, Azadi sq., Isfahan
City
Isfahan
Postal code
Phone
+98 31 1778 2798
Fax
Email
ataei_ehsan109@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences.
Full name of responsible person
Ehsan Ataei
Position
Student of pharmacy
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Daneshgah st. beginning, Azadi sq., Isfahan
City
Isfahan
Postal code
Phone
+98 31 1778 2798
Fax
Email
ataei_ehsan109@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Ehsan Ataei
Position
Student of pharmacy
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Daneshgah st. beginning, Azadi sq., Isfahan
City
Isfahan
Postal code
Phone
+98 31 1778 2798
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)