Safety evaluation of saffron (Crocus sativus) tablets in healthy volunteers.
Saffron (Crocus sativus) stigma tablets were evaluated for short-term safety and tolerability in healthy adult volunteers. The study was a double-blind, placebo-controlled design consisting of a 1 week treatment of saffron tablets. Volunteers were divided into 3 groups of 10 each (5 males and 5 females). Group I received placebo; groups 2 and 3 received 200 and 400mg saffron tablets, respectively, for 7 days. General measures of health were recorded during the study such as hematological, biochemical and electrocardiographic parameters done in pre- and post-treatment periods. Clinical examination showed no gross changes in all volunteers after intervention. Saffron with higher dose (400mg) decreased standing systolic blood pressure and mean arterial pressures significantly. Saffron decreased slightly some hematological parameters such as red blood cells, hemoglobin, hematocrit and platelets. Saffron increased sodium, blood urea nitrogen and creatinine. This study showed that saffron tablets may change some hematological and biochemical parameters. However, these alterations were in normal ranges and they were not important clinically.
Modaghegh
Mohammad-Hadi
MH
Mashhad Vascular Surgery Research Center, Imam Reza Hospital, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad (MUMS), Islamic Republic of Iran.
Shahabian
Masoud
M
Esmaeili
Habib-Allah
HA
Rajbai
Omid
O
Hosseinzadeh
Hossein
H
D000328:Adult; D001769:Blood / Q000187:drug effects*; D001772:Blood Cell Count; D001794:Blood Pressure / Q000187:drug effects*; D027622:Crocus / Q000737:chemistry*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007677:Kidney Function Tests; D008297:Male; D008875:Middle Aged; D028321:Plant Preparations / Q000009:adverse effects*; D011674:Pulse; D013607:Tablets; D055815:Young Adult
D028321:Plant Preparations; D013607:Tablets