Safety evaluation of saffron ( Crocus sativus) tablets in healthy volunteers

• Published in: Phytomedicine (Stuttgart) Vol. 15; no. 12; pp. 1032 - 1037
• Main Authors: Modaghegh, Mohammad-Hadi, Shahabian, Masoud, Esmaeili, Habib-Allah, Rajbai, Omid, Hosseinzadeh, Hossein
• Format: Journal Article
• Language: English
• Published: Germany Elsevier GmbH 01-12-2008; Urban & Fischer Verlag
• Subjects: Adult; Blood - drug effects; Blood Cell Count; Blood Pressure - drug effects; Chemical properties; Clinical trial; Clinical trials; Crocus - chemistry; Double-Blind Method; Female; Health aspects; Human volunteers; Humans; Kidney Function Tests; Male; Management; Middle Aged; Plant Preparations - adverse effects; Pulse; Safety assessment; Saffron ( Crocus sativus); Saffron crocus; Tablets; Young Adult; Iran; Clinical trial; Safety assessment; Saffron ( Crocus sativus); Human volunteers
• ISSN: 0944-7113; 1618-095X
• DOI: 10.1016/j.phymed.2008.06.003

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 400
mg 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 (400
mg) 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.