title: Safety Evaluation of Crocin (a constituent of saffron) Tablets in Healthy Volunteers.
abstract: OBJECTIVE
  Crocin is the chemical ingredient primarily responsible for the color of saffron. It has different pharmacological effects such as antioxidant, anticancer and memory improving activities. Crocin tablets were evaluated for short-term safety and tolerability in healthy adult volunteers.
  
  
  METHODS
  The study was a randomized, double-blind, placebo-controlled design consisting of one month treatment of crocin tablets. Volunteers who fulfilled inclusion and exclusion criteria were randomized into 2 groups of 22 each (males and females) and received 20 mg crocin tablets or placebo. General measures of health were recorded during the study such as hematological, biochemical, hormonal and urinary parameters in pre and post-treatment periods.
  
  
  RESULTS
  No major adverse events were reported during the trial. Crocin tablets did not change the above parameters except that it decreased amylase, mixed white blood cells and PTT in healthy volunteers after one month.
  
  
  CONCLUSIONS
  This clinical safety evaluation showed a relatively safe and normal profile for crocin in healthy volunteers at the given doses within the trial period.
authors: Pharmaceutical Research Center, Department of Pharmacodynamy and Toxicology, School of Pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran.
authors: Amir Houshang
authors: AH
authors: Mohamadpour
authors: Zahara
authors: Z
authors: Ayati
authors: Mohammad-Reza
authors: MR
authors: Parizadeh
authors: Omid
authors: O
authors: Rajbai
authors: Hossein
authors: H
authors: Hosseinzadeh
keywords: Clinical trial; Crocin; Crocus sativus; Human volunteers; Safety assessment; Saffron
references: Pak J Biol Sci. 2010 Jul 15;13(14):691-8
references: 21848061
references: Brain Res. 2007 Mar 23;1138:86-94
references: 17274961
references: Phytomedicine. 2008 Dec;15(12):1032-7
references: 18693099
references: Phytother Res. 2010 May;24(5):726-30
references: 19827024
references: Phytother Res. 2011 Dec;25(12):1801-5
references: 21480412
references: DNA Cell Biol. 2008 Dec;27(12):657-64
references: 18788978
references: Eur J Pharmacol. 2006 Aug 14;543(1-3):116-22
references: 16828739
references: Phytomedicine. 2011 Apr 15;18(6):499-504
references: 21036580
references: Phytomedicine. 2007 Sep;14(9):633-6
references: 17215113
references: Exp Oncol. 2007 Sep;29(3):175-80
references: 18004240
references: J Agric Food Chem. 2008 Oct 22;56(20):9429-33
references: 18817408
references: Cell Mol Neurobiol. 2012 Mar;32(2):227-35
references: 21901509
references: J Pharm Pharm Sci. 2005 Aug 22;8(3):387-93
references: 16401388
references: Exp Biol Med (Maywood). 2002 Jan;227(1):20-5
references: 11788779
references: Psychopharmacology (Berl). 2010 Jan;207(4):637-43
references: 19838862
references: Phytomedicine. 2008 Jun;15(6-7):491-5
references: 17962007
references: World J Gastroenterol. 2008 Oct 28;14(40):6188-94
references: 18985809
references: Phytomedicine. 2010 Mar;17(3-4):227-32
references: 19747807
references: Phytother Res. 2010 Jul;24(7):990-4
references: 20013822
references: Phytother Res. 2012 Mar;26(3):381-6
references: 21774008
references: Food Chem Toxicol. 2010 Oct;48(10):2803-8
references: 20637253
references: Phytother Res. 2005 Feb;19(2):148-51
references: 15852492
references: Evid Based Complement Alternat Med. 2009 Sep;6(3):343-50
references: 18955256
references: Nutr Res. 2009 Mar;29(3):145-50
references: 19358927
references: J Agric Food Chem. 2005 Sep 7;53(18):7302-6
references: 16131146
references: Phytomedicine. 2009 Aug;16(8):690-3
references: 19427775