Effects of a saffron extract (affron) on climacteric symptoms in perimenopausal women: a randomised, double-blind, placebo-controlled study

Clinical Research Australia0 个研究点目标入组 86 人开始时间: 2020年3月12日最近更新: 2021年10月18日

适应症

试验速览

暂无简介。

•1.Healthy women aged 40 to 60 years
•2.Reports of changes in the menstrual cycle for at least 3 months
•3.Presence of climacteric symptoms for at least 3 months, with a total score greater than or equal to 16 on the GCS
•4.Women with an intact uterus and ovaries
•5.Medication-free for at least 3 months. Use of analgesics (once a week) and/or contraceptive pills are permissible.
•6.Non-smoker
•7.No plan to commence new treatments over the study period
•8.Willing and able to take prescribed saffron/placebo tablets for 12 weeks
•9.BMI between 18 and 35 kg/m2
•10.Willing to provide a personally signed and dated informed consent form detailing all pertinent aspects of the trial.

•1.Have not had a period in the last 12 months
•2.Suffering from a medical condition including but not limited to, diabetes, hyper/hypotension, cardiovascular disease, a gastrointestinal disease requiring regular use of medications, gallbladder disease/gallstones/biliary disease, endocrine disease, psychiatric disorder, and neurological disease (Parkinson’s, Alzheimer’s disease, intracranial haemorrhage, head or brain injury)
•3.Any significant surgeries over the last year
•4.Current or 12-month history of illicit drug abuse
•5.Alcohol consumption > 14 standard drinks per week
•6.Current use of supplements that may affect the climacteric syndrome
•7.Currently taking saffron supplements

发起方

Clinical Research Australia