Protocol summary

Summary
This study aims to investigate the effect of the Capparis Spinosa pickle on Lipid Profile, Liver Enzymes, Fasting Blood Glucose, BUN & Cr among Hypercholesterolemia patients. The total sample was 60 people, which included the two intervention and control groups (30 people each). Using the Rend I & II software, the samples were randomly divided into the two intervention and control groups. The study was not blinded. Inclusion criteria: Hyperlipidemia (LDL≥ 100 based on Framingham criteria); sex: male, age 40 to 60 years. Exclusion criteria: Hyperlipidemia during treatment; pregnancy and lactation; CHD patient; BP ≥ 140/90; Coagulopathies; thyroid disease; Having a particular diet, or the consumption of medicine that affects blood lipid level (e.g. OCP, corticosteroid, etc.), special illnesses that affect lipid profile (e.g. renal failure), discontinuing treatment at any stage, smoking, drug and alcohol abuse, taking medicine or doing anything that affects lipid profile 30 days prior to the study, any side effect that might stop treatment, major stress levels based on DSM IV during the study or the last three months. Variables are lipid profile, liver enzymes, FBS, BUN, Cr & appetite Interventions included: Standard Treatment (a training course in lifestyle & 10 mg Atorvastatin tablets) to both groups, daily consumption of 40 grams of Capparis Spinosa pickle (only offered to the intervention group) for 8 weeks

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017032827532N1
Registration date: 2017-03-28, 1396/01/08
Registration timing: prospective

Last update:
Update count: 0
Registration date
2017-03-28, 1396/01/08
Registrant information
Name
Saeed Sardari
Name of organization / entity
Shahed University
Country
Iran (Islamic Republic of)
Phone
+98 21 51210
Email address
s.sardari@shahed.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahed University
Expected recruitment start date
2017-07-30, 1396/05/08
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The investigation of the effects of Capparis Spinosa pickle on lipid profile in hypercholesterolemia.
Public title
Effects of Capparis pickle on blood lipid
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Hyperlipidemia (LDL≥ 100 based on Framingham criteria), sex: male, age 40 to 60 years. Exclusion criteria: Hyperlipidemia during treatment; pregnancy and lactation; CHD patient; BP ≥ 140/90; Coagulopathies; thyroid disease; Having a particular diet, or the consumption of medicine that affects blood lipid level (e.g. OCP, corticosteroid, etc.); special illnesses that affect lipid profile (e.g. renal failure); discontinuing treatment at any stage; smoking, drug and alcohol abuse; taking medicine or doing anything that affects lipid profile 30 days prior to the study; any side effect that might stop treatment and major stress levels based on DSM IV during the study or the last three months.
Age
From 40 years old to 60 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shahed University
Street address
Shahed University, in front of the shrine Imam Khomeini (RA), Persian Gulf Highway
City
Tehran
Postal code
3319118651
Approval date
2017-02-28, 1395/12/10
Ethics committee reference number
IR,Shahed,REC,1395,203

Health conditions studied

1

Description of health condition studied
Hypercholesterolemia
ICD-10 code
E78.0
ICD-10 code description
Pure hypercholesterolemia

Primary outcomes

1

Description
Serum Low Density Lipoprotein- Cholestrol Level
Timepoint
Before the intervention, the end of the 4th & 8th week intervention
Method of measurement
Blood sample

2

Description
Serum High Density Lipoprotein- Cholesterol Level
Timepoint
Before the intervention, the end of the 4th & 8th week intervention
Method of measurement
Blood sample

3

Description
Serum Total Cholesterol Level
Timepoint
Before the intervention, the end of the 4th & 8th week intervention
Method of measurement
Blood sample

4

Description
Serum Triglyceride Level
Timepoint
Before the intervention, the end of the 4th & 8th week intervention
Method of measurement
Blood sample

5

Description
Added at 2017-11-18: Apptetite
Timepoint
Added at 2017-11-18: Before intervention and at the end of study
Method of measurement
Added at 2017-11-18: VAS questionnaire

Secondary outcomes

1

Description
Serum Glutamic Pyruvic Teransamins
Timepoint
Before the intervention, the end of the 4th & 8th week intervention
Method of measurement
Blood sample

2

Description
Serum Glutamic Oxaloacetic Transaminase
Timepoint
Before the intervention, the end of the 4th & 8th week intervention
Method of measurement
Blood sample

3

Description
Fasting Blood Suger
Timepoint
Before the intervention, the end of the 4th & 8th week intervention
Method of measurement
Blood sample

4

Description
Serum Blood Urea Nitrogen Level
Timepoint
Before the intervention, the end of the 4th & 8th week intervention
Method of measurement
Blood sample

5

Description
Serum Creatinine Level
Timepoint
Before the intervention, the end of the 4th & 8th week intervention
Method of measurement
Blood sample

6

Description
Added at 2017-11-18: Sleep disorders
Timepoint
Added at 2017-11-18: Before intervention and at the end of study
Method of measurement
Added at 2017-11-18: Sleep questionnaire

Intervention groups

1

Description
Intervention 1: The intervention group in addition to Standard Treatment (a training course in lifestyle & 10 mg Atorvastatin tablets), daily intake of 40 mg pickled capers with meals for lunch and dinner.
Category
Treatment - Drugs

2

Description
Intervention 2:Control group, Standard Treatment (a training course in lifestyle & 10 mg Atorvastatin tablets)
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Education & Treatment Center Of Valiasr
Full name of responsible person
Saeed Sardari
Street address
Sheikh Fazlullah Nuri highway, Valiasr Square, Education & Treatment Center Of Valiasr
City
Zanjan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Shahed University
Full name of responsible person
Zahra Kiasalari
Street address
Shahed University, in Front of the Shrine of Imam Khomeiny , Persian Golf Freeway
City
Tehran
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, Shahed University
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
Shahed University
Full name of responsible person
Saeed Sardari
Position
Ph.D Student in Iranian Traditional Medicine
Other areas of specialty/work
Street address
Shahed University, in front of the shrine Imam Khomeini (RA), Persian Gulf Highway
City
Tehran
Postal code
3319118651
Phone
+98 21 51210
Fax
Email
s.sardari@shahed.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahed University
Full name of responsible person
Sayyed Saeed Esmaeili Saber
Position
Associate Professor of Traditional Medicine
Other areas of specialty/work
Street address
Shahed University, in Front of Imam Khomeini Holy Shrine, Persian Gulf Highway
City
Tehran
Postal code
3319118651
Phone
+98 21 51210
Fax
Email
esmaeili@chmail.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahed University
Full name of responsible person
Saeed Sardari
Position
PhD Student of Traditional Medicine
Other areas of specialty/work
Street address
Shahed University, in front of the shrine Imam Khomeini (RA), Persian Gulf Highway
City
Tehran
Postal code
3319118651
Phone
+98 21 51210
Fax
Email
s.sardari@shahed.ac.ir
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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