Pharmaceutical Research Center, Department of Pharmacodynamy and Toxicology, School of Pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran.
Iran J Basic Med Sci. 2013 Jan;16(1):39-46.
OBJECTIVE(S): 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.
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.
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.
This clinical safety evaluation showed a relatively safe and normal profile for crocin in healthy volunteers at the given doses within the trial period.
藏红花中的主要化学成分西红花苷是赋予藏红花颜色的物质。它具有多种药理作用，如抗氧化、抗癌和改善记忆等。本研究旨在评估藏红花片在健康成年志愿者中的短期安全性和耐受性。
这是一项随机、双盲、安慰剂对照研究，为期 1 个月，志愿者接受藏红花片或安慰剂治疗。符合纳入和排除标准的志愿者被随机分为两组（每组 22 人，包括男性和女性），分别接受 20mg 藏红花片或安慰剂治疗。在研究期间记录了一般健康指标，包括治疗前后的血液学、生化学、激素和尿液参数。
试验过程中未报告重大不良事件。除了在 1 个月后降低了淀粉酶、混合白细胞和 PTT 外，藏红花片未改变上述参数。
在试验期间，给予健康志愿者藏红花片的剂量范围内，该临床安全性评估显示藏红花具有相对安全和正常的特征。
