Objective: Some of the adverse effects of aspirin including peptic ulcers, gastrointestinal bleeding and aspirin resistance completed researchers to look for search for a suitable alternative with fewer adverse effects. The aim of this study was to determine the mechanism of antiplatelet effects of garlic and then, in a clinical trial, obtain the effective dose of antiplatlet effects of garlic.
Method: This Randomized controlled clinical trial (RCT) was conducted on 62 healthy volunteers with age range of 20 to 50 years. Platelet aggregation induced by 4 known agonists acting in aggregation pathway including ADP(20μ mol/l) ) , epinephrine( EPN)( (20μ mol/ l ), collagen(0.19 mg/ ml ) and arachidonic acid (AA)( 0.5mg/ ml ) was measured by Light Transmittance Aggregometry (LTA; HELENA PACKS -4). All volunteers used 80 mg aspirin per day for 1 week and at the end of this time, platelet aggregation (PA) was measured by the mentioned agonists. To find an effective dose of garlic, volunteers were divided into 3 groups and each received1,or 2 or3 garlic tablets a day for 1 month, randomly. After one month PA was examined for all groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012073110453N1
Registration date:2014-09-26, 1393/07/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-09-26, 1393/07/04
Registrant information
Name
Mojtaba Shafiekhani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3242 4255
Email address
mshafikhan@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Pharmaceutical Science Research Center(PSRC) OF Shiraz University Of Medical Sciences
Expected recruitment start date
2014-08-24, 1393/06/02
Expected recruitment end date
2014-09-01, 1393/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comprasion of antiplatelet activity of garlic tablets with cardioprotective dose of aspirin (80mg/day)in healthy volunteers
Public title
antiplatelet effects of garlic
Purpose
Treatment
Inclusion/Exclusion criteria
Exclusion criteria applied to individuals who had cardiovascular disease, been using aspirin, clopidogrel and nonsteroidal anti inflammatory drugs ( NSAIDS) in the last 2 weeks ago , thrombocytopenia(platelet<100 × 10 3 platelets /mm3 ), anemia(hemoglobin<10g/dl),abnormal lipid profile[total chlosterol ≥ 200 mg/dl , LDL-C ≥100mg/dl , TG ≥ 200 mg/dl HDL≤ 45 mg/dl(male) and ≤ 55 mg/dl(female) ], Diabetes mellitus (FBS ≥ 126 mg/ dl confirmed by repeating the test), and renal failure[Serum creatinine ≥ 2mg/dl (female) and Serum creatinine≥2.5 mg/dl (male)]
inclusion criteria : 62 healthy individuals(non diabetic ؛ normal lipid profile ؛ without any cardiovascular disease and coagulation disordes ؛non used aspirin, clopidogrel and nonsteroidal anti inflammatory drugs ( NSAIDS) in the last 2 weeks ago aged 20-50 years old were enrolled in this clinical trial.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
62
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Zand blvd
City
Shiraz
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
ct-p-91-4598
Health conditions studied
1
Description of health condition studied
agents affecting blood constituents
ICD-10 code
Y44.9
ICD-10 code description
Other and unspecified agents affecting blood constituents
Primary outcomes
1
Description
platelet aggregation
Timepoint
3 months
Method of measurement
Light transmission aggregometer
Secondary outcomes
empty
Intervention groups
1
Description
garlic 1250mg one tablet a day for 30 days
Category
Treatment - Drugs
2
Description
garlic(1250mg) 2 tablets a day for 30 days
Category
Treatment - Drugs
3
Description
3 tablets(1250 mg) garlic a day for 30 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Dastgheib Hospital
Full name of responsible person
Mojtaba Shafikhani
Street address
Hafeziye Blvd
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Pharmaceutical Siences Reseaserch
Full name of responsible person
Dr. Yunes Ghasemi
Street address
Zand blvd
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Pharmaceutical Siences Reseaserch
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
Mojtaba Shafikhani
Position
student
Other areas of specialty/work
Street address
Valiasr sq
City
Shiraz
Postal code
Phone
+98 71 1727 4596
Fax
Email
mshafikhan@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University Of Medical Sciences
Full name of responsible person
Soha Namzai
Position
professor
Other areas of specialty/work
Street address
Ghasrodasht sq
City
Shiraz
Postal code
Phone
+98 71 1242 4255
Fax
Email
cadimapegra74@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University Of Medical Sciences
Full name of responsible person
Mojtaba Shafikhani
Position
student
Other areas of specialty/work
Street address
Valiasr sq
City
Shiraz
Postal code
Phone
+98 71 1727 4596
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)