This study aimed to determine the effect of ginger supplementation on clinical outcomes, quality of life, change of lipid profile and glucose, before and after the study was conducted in male patients with atherosclerosis. The total number of patients participating in the study is 60 people, including two groups of patients: atherosclerosis ginger supplement and control group taking placebo. The number of participants in each group of 30 people. This study is a triple blind and patients were imported to each group randomly. The intervention will continue for two months. Exclusion criteria is supplement intake to less than 80 percent of the total, changing the type and amount of medication during the intervention and the unwillingness to continue to cooperate in the study. Serum samples were stored at -70 ° C and cholesterol levels, HDL LDL VLDL FBS triglyceride levels measured by spectrophotometric methods and ELISA after intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015100424348N1
Registration date:2016-05-13, 1395/02/24
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-05-13, 1395/02/24
Registrant information
Name
Maryam Alasvand
Name of organization / entity
Ahwaz Jundishapoor Univercity of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3374 3001
Email address
alasvand.m@stu.ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Ahwaz University of Medical Sciences
Expected recruitment start date
2015-10-11, 1394/07/19
Expected recruitment end date
2015-12-22, 1394/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of ginger supplementation on the lipid profile, glucose and functional capacity and quality of life of heart patients with atherosclerosis
Public title
Ginger effect on atherosclerotic patient
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: men 40 to 70 years with involvement of at least one coronary artery in angiography which are undergoing medical treatment , not re- vascularization.
Exclusion criteria : drug with serious side effects , the lack of willingness to cooperate , less than 80 % of the drug is consumed, perform open heart surgery or stents during the study
Age
From 40 years old to 70 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)
Triple 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 Ahwaz Jundishapoor University of Medical science
Street address
Golestan road
City
Ahwaz
Postal code
Approval date
2015-09-16, 1394/06/25
Ethics committee reference number
IR.AJUMS.REC.1394.346
Health conditions studied
1
Description of health condition studied
Atherosclerosis
ICD-10 code
I25
ICD-10 code description
Chronic ischaemic heart disease
Primary outcomes
1
Description
ESR
Timepoint
Before &after exam
Method of measurement
Mg
2
Description
Quality of life
Timepoint
Before and after finish exam
Method of measurement
Questionaier
3
Description
Exercise capacity
Timepoint
Before & after
Method of measurement
Exercse treadmil test
4
Description
Weight
Timepoint
Before &after exam
Method of measurement
Kg
5
Description
Fasting blood suger
Timepoint
Before&after
Method of measurement
mg
6
Description
triglycerides
Timepoint
Before&after
Method of measurement
Mg
7
Description
Cholesterol
Timepoint
Before&after exam
Method of measurement
mg
Secondary outcomes
empty
Intervention groups
1
Description
Control group : every day , 1,600 mg of rice flour placebo ( 1 capsule of 800 mg Before breakfast and 1 capsule of 800 mg before dinner ) consume
Category
Treatment - Drugs
2
Description
Intervention group : every day , 1,600 mg of ginger rhizome powder ( 1 capsule of 800 mg Before breakfast and 1 capsule of 800 mg before dinner ) consume
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Hospital
Full name of responsible person
Dr Alasvand
Street address
24 Meter Street
City
Ahwaz
2
Recruitment center
Name of recruitment center
Golestan Hospital
Full name of responsible person
Dr Alasvand
Street address
Golestan
City
Ahwaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, University of Medical Sciences Of Ahwaz
Full name of responsible person
Mr Dianat
Street address
Golestan
City
Ahwaz
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, University of Medical Sciences Of Ahwaz
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
Ahwaz JondiShapor Univercity of Medical Sciences
Full name of responsible person
Dr Saki
Position
Research Assistant Ahwaz JondiShapor University of Medical Sciences
Other areas of specialty/work
Street address
Golestan
City
Ahwaz
Postal code
Phone
00
Fax
Email
vchresearch.ajums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahwaz JondyShapor Univercity of Medical Sciences
Full name of responsible person
Dr Maryam Alasvand
Position
Resident
Other areas of specialty/work
Street address
Golestan road
City
Ahwaz
Postal code
Phone
00
Fax
Email
alasvand1361@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahwaz Jundishapoor Univercity of Medical Sciences
Full name of responsible person
Dr Maryam Alasvand
Position
Resident
Other areas of specialty/work
Street address
24 Metery، Emam Hospital
City
Ahwaz
Postal code
Phone
00
Fax
Email
mari.alasvand@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)