Protocol summary

Summary
Effect of Ginger supplementation on serum lysophosphatidic acid,lipid profile, Total Antioxidan capacity and high-sensitivity C-reactive protein in atherosclerotic patient. atherosclerosis is one of the main problem in growing country. ginger is natural herb that used by many people with foods and tea. recently some studies shown that ginger have noninflammatory and antioxidant properties. 1- The objectives were: to determine the levels of Lysophosphatidic acid, lipid profile, Total Antioxidan capacity and high-sensitivity C-reactive protein in control and treated group( consuming ginger). 2- Design of the study :initially 60 patients with atherosclerosis determined by a Cardiologist, dividing patients into two groups of 30 people, including patients taking ginger and the control group (patients taking placebo), getting consent and interview them about their general profile and clinical records of patients, measuring height and weight and determine the Body Mass Index (BMI) of patients. Provided dry ginger powder and Preparation capsules containing 800 mg of powdered ginger rhizome. Placebo containing wheat flour is provided in a similar way and in the same form and color.To create the aroma in the placebo capsules, the capsules is placed near the ginger powder for 2 weeks and then packed in cans similar. Patients take , 1600 mg of powdered rhizome of ginger or placebo ( 1 capsule of 800 mg before lunch and 1 capsule of 800 mg before dinner). The intervention will continue for 2 months. then 5 ml of blood is taken from each groups. And then separate serum samples.Serum samples were stored at -70 ° C and then studied markers are measured by the spectrophotometric methods and ELISA. 3-Participants including major eligibility criteria: Inclusion criteria included: all patients (men and women) with atherosclerosis eligible for medical treatment by Cardiologist; and age 40 to 70 years. exclusion criteria including: those patient consuming below 80% of supplement; and change drugs in during intervention. 4- Interventions include: the use of capsules containing 800 mg of powdered ginger rhizome and a placebo containing wheat flour. 5- The main outcome measures variable included: Lysophosphatidic acid, lipid profile, Total Antioxidant capacity and high-sensitivity C-reactive protein.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015091524025N1
Registration date: 2015-12-02, 1394/09/11
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-12-02, 1394/09/11
Registrant information
Name
Hossein Babaahmadi Rezaei
Name of organization / entity
Ahvaz Jundishgapur Universiry Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 930 862 8011
Email address
babaahmadi-h@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Ahvaz Jundishapur University Of Medical Sceiences
Expected recruitment start date
2015-10-25, 1394/08/03
Expected recruitment end date
2015-11-29, 1394/09/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Ginger supplementation on serum lysophosphatidic acid,lipid profile, Total Antioxidan capacity and high-sensitivity C-reactive protein in atherosclerotic patient
Public title
Effect of ginger on the lipid profile and inflammatory factors
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria included: all patients (men and women) with atherosclerosis eligible for medical treatment by Cardiologist; and age 40 to 70 years. exclusion criteria including: those patient consuming below 80% of supplement; and change drugs in during intervention.
Age
From 40 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
N/A
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
Ethics committee of Ahvaz jundishapur university of medical sciences
Street address
Ethics committee of Jundishapur University Of Medical Science, Golestan street, Ahvaz
City
Ahvaz
Postal code
15794-61357
Approval date
2015-08-08, 1394/05/17
Ethics committee reference number
IR.AJUMS.REC.1394.294

Health conditions studied

1

Description of health condition studied
Atherosclerosis
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease

Primary outcomes

1

Description
Lysophosphatidic acid
Timepoint
after two month intervention
Method of measurement
Elisa methods

2

Description
Lipids profile
Timepoint
after two month intervention
Method of measurement
chemical methods

3

Description
Total antioxidant capacity
Timepoint
after two month intervention
Method of measurement
chemical methods

4

Description
high-sensitivity C-reactive protein
Timepoint
after two month intervention
Method of measurement
Elisa methods

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: atherosclerotic patient that intervention with ginger with doses of 1600 mg ginger per day ( 800 mg before lunch and 800 mg before dinner). The intervention will continue for 2 months.
Category
Treatment - Drugs

2

Description
Control group: receive Placebo that contain wheat flour. To create the aroma in the placebo capsules, the capsules is placed near the ginger powder for 2 weeks and then packed in cans similar. Patients take , 1600 mg of placebo ( 1 capsule of 800 mg before lunch and 1 capsule of 800 mg before dinner). The intervention will continue for 2 months.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Emam Khomeini hospital Ahvaz
Full name of responsible person
Dr Adel
Street address
Cardiology Depatrment Emam Khomeini hospital, Golestan street,Ahvaz
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Ahvaz Jundishapur University Of Medical Sceiences
Full name of responsible person
Dr.Hossein Babaahmadi
Street address
Ahvaz Jundishapur University Of Medical Sceiences, Street Golestan, Ahvaz
City
Ahvaz
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, Ahvaz Jundishapur University Of Medical Sceiences
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
Ahvaz Jundishapur University Of Medical Sceiences
Full name of responsible person
Dr.Hoseein Babaahmadi
Position
Ph.D
Other areas of specialty/work
Street address
Jundishapur University Of Medical Sceiences, Golestan street, Ahvaz
City
Ahvaz
Postal code
15794-61357
Phone
+98 61 3336 7543
Fax
Email
babaahmadi-h@ajums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University Of Medical Sciences
Full name of responsible person
Dr.Hossein Babaahmadi
Position
Ph.D
Other areas of specialty/work
Street address
Golestan street, Ahvaz
City
Ahvaz
Postal code
15794-61357
Phone
+98 61 3336 7543
Fax
Email
babaahmadi-h@ajums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University Of Medical Sciences
Full name of responsible person
Dr.Hossein Babaahmadi
Position
Ph.d
Other areas of specialty/work
Street address
Jundishapur University Of Medical Sciences,Golestan street, Ahvaz
City
Ahvaz
Postal code
15794-61357
Phone
+98 61 3336 7543
Fax
Email
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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