Objectives: To evaluate the effects of Rhus coriaria (Sumac) on serum lipid levels of patients with hyperlipidemia
Design: Double-blind placebo-controlled randomized clinical trial
Method:74 hyperlipidemic patients with the inclusion criteria will enter into the study and randomly assign to treatment or placebo group.
Inclusion criteria:
• Age: 20-65 years old.
• Serum triglyceride more than 150mg/dl and /or total cholesterol equal or more than 240mg/dl.
Exclusion criteria:
• Serum triglyceride more than 500 mg/dl.
• Serum LDL-cholesterol at level which need drug treatment according to the patient risk categories (NCEPATP III).
• Diabetes mellitus.
• Hypo or hyperthyroidism.
• Any systemic illnesses e.g. liver cirrhosis, acute or chronic renal failure, heart failure.
• Use of drugs: OCPs, lipid lowering agents, thiazides.
• Pregnancy.
• Alcoholism.
• History of allergic reaction to Sumac.
Interventions: One group recieve Sumac powder 500 cap. twice daily and another group recieve placebo cap. twice daily for 6 weeks.
Primary outcom measures: serum total cholesterol, triglyceride,LDL-cholesterol and HDL-cholesterol levels.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014030716876N1
Registration date:2015-07-24, 1394/05/02
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-07-24, 1394/05/02
Registrant information
Name
Mesbah Shams
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4316
Email address
shams@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2014-10-01, 1393/07/09
Expected recruitment end date
2015-04-01, 1394/01/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effects of Rhus Coriaria L. (Sumac) on Serum Lipid Levels of Patients With Hyperlipidemia
Public title
Use of Sumac in treatment of hyperlipidemia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
• Age: 20-65 years old.
• Serum triglyceride more than 150mg/dl and /or total cholesterol equal or more than 240mg/dl.
Exclusion criteria:
• Serum triglyceride more than 500 mg/dl.
• Serum LDL-cholesterol at level which need drug treatment according to the patient risk categories (NCEPATP III).
• Diabetes mellitus.
• Hypo or hyperthyroidism.
• Any systemic illnesses e.g. liver cirrhosis, acute or chronic renal failure, heart failure.
• Use of drugs: OCPs, lipid lowering agents, thiazides.
• Pregnancy.
• Alcoholism.
• History of allergic reaction to Sumac.
Age
From 20 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
74
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
ClinicalTrials.gov
Secondary trial Id
NCT02295293
Registration date
2014-11-10, 1393/08/19
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committe
Street address
Shiraz University of Medical Sciences
City
Shiraz
Postal code
Approval date
2015-02-16, 1393/11/27
Ethics committee reference number
CT-P-92-5581
Health conditions studied
1
Description of health condition studied
Hyperlipidemia
ICD-10 code
E78.5
ICD-10 code description
Hyperlipidaemia, unspecified
Primary outcomes
1
Description
Serum total cholesterol level
Timepoint
6 weeks
Method of measurement
Biochemical analysis
2
Description
Serum triglyceride level
Timepoint
6 weeks
Method of measurement
Biochemical analysis
3
Description
Serum HDL-cholesterol level
Timepoint
6 weeks
Method of measurement
Biochemical analysis
4
Description
Serum LDL-cholesterol level
Timepoint
6 weeks
Method of measurement
Biochemical analysis
Secondary outcomes
1
Description
Serum ALT level
Timepoint
6 weeks
Method of measurement
Biochemical analysis
2
Description
Serum AST level
Timepoint
6 weeks
Method of measurement
Biochemical analysis
3
Description
Fasting Blood Sugar (FBS)
Timepoint
6 weeks
Method of measurement
Biochemical analysis
4
Description
Serum creatinin level
Timepoint
6 weeks
Method of measurement
Biochemical analysis
5
Description
Serum alkaline phosphatase level
Timepoint
6 weeks
Method of measurement
Biochemical analysis
Intervention groups
1
Description
Drug: Rhus Coriaria L. (Sumac)
500 mg of Rhus Coriaria L. (Sumac) powder in capsule
1 capsule twice daily for 6 weeks
Category
Treatment - Drugs
2
Description
Placebo capsule: 1 capsule twice daily for 6 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Motahhari Clinic, Shiraz University of Medical Sciences
Full name of responsible person
Mesbah Shams
Street address
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor of Research, Shiraz University of Medical Sciences
Full name of responsible person
Dr. Seyyed Basir Hashemi
Street address
Shiraz University of Medical Sciences, Zand st.
City
Shiraz
Grant name
Grant code / Reference number
91-01-01-5581
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor of Research, Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Mesbah Shams
Position
M.D.
Other areas of specialty/work
Street address
Endocrinology & Metabolism Research Center-Shiraz University of Medical Sciences
City
Shiraz
Postal code
Phone
+98 71 3647 4316
Fax
Email
shams@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Endocrinology and Metabolism Research Center
Full name of responsible person
Mesbah Shams
Position
M.D.
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences
City
Shiraz
Postal code
Phone
+98 71 3647 4316
Fax
Email
shams@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Endocrine and Metabolism Research Center, Shiraz University of Medical Sciences
Full name of responsible person
Mesbah Shams
Position
MD
Other areas of specialty/work
Street address
Nemazee Teaching Hospital
City
Shiraz
Postal code
Phone
+98 71 3647 4316
Fax
Email
shams@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)