National Research Centre

Medical Research Ethics Committee

MREC Reviewer Comment

Protocol Title

Assessment of Biological and Chemical Influence of the Natural plant Garlic on Lipid Metabolism and the Cardiovascular risk as an Environmental Plant Medicine

Completely satisfied and informative data

Disapprove

Comments to the applicant

الملف لا يحتوى على طلب التقدم وموافقة المشرفين على الرسالة للتقدم للجنة اخلاقيات البحوث الطبية بالمركز القومى للبحوث                                                                                                     The template lacks the required data concerning standardization,method of preparation and administration of Herbal medicine(Allium sativum L ).The (EDA) and (EMA) standardized the daily effective dose used in the treatment of elevated blood lipids and reduction of cardio vascular risk by the amount of the active principle allicin that it contains which is equivalent to (3 - 5 mg approximately of allicin ) while garlic cloves yield   2.5-4,5 mg of allicin/gm of fresh weight when crushed (Lawson et al 1998),therefore using 5 gm of crushed garlic in a single daily dose retains high amount of allicin which may increase the risk of bleeding,irritate the digestive tract,burning sensation  of the chest and stomach (PDR) and deterioration of liver functions (S.V.Rana et al,2006).                               References.                                                                                                          1)(EDA) Egyptian Drug Authority Egyptian Herbal monograph, Medicinal Plants used in Egypt (vol 3) ( 2024), Allium sativum L..

2) (EMA) European Medicine Agency-Sciences Medicine Health, 12 July ( 2016)

3) Lawson LD.. Garlic review of its medicinal effects and indicated active compounds. In.Lawson LD, Bauer R, eds. Phytomedicine of Europe, Chemistry and Biological Activity, Washington, D.C. : American Chemical Society, 1998, 177-209

4) PDR for Herbal Medicines - Second Edition p 328 

5) S.V.Rana etal,  Trop. Gastroenterol. 2006,(Jan-March) 27(1) , 26-30 

Comment to the Committee

Informed consent form:

Needs Modification

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