Investigation of the Psychological and Physiological Effects of a Standardised Saffron Extract Supplementation on Symptoms Associated to Perimenopause in Healthy Older Women: A Randomised Double-blind, Placebo-Controlled, Parallel-group Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 104
- 试验地点
- 2
- 主要终点
- Effect on overall perimenopause clinical symptoms severity
研究概览
简要总结
The aim of the present study is to assess the effects of a normalised saffron extract supplementation, which is an extract of the flower Crocus sativus, on perimenopausal symptoms.
详细描述
After being informed about the study protocol aim and potential risks, healthy volunteer woman (walk-in outpatients) will undergo a pre-screening to determine eligibility for study entry. At the visit 1, patients who meet the pre-screening criteria will undergo a second screening to confirm their eligibility based on inclusion and exclusion criteria. After signing the inform consent form, patient who meet eligibility criteria will be randomised in a double-blind manner (participants and investigators) in a 1:1 ratio to saffron extract supplementation (15mg, twice daily) or matched placebo (twice daily) for a period of 3-months (12 weeks).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Randomisation will be processed by computer-generated random sequence number and will be performed by an independent member of the medical support team which will not be involved in the study
入排标准
- 年龄范围
- 40 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Biological Female which identify themselves as Women
- •Aged ≥ 40 years
- •Irregular menstrual cycle for at least 3 months
- •Presenting typical symptoms of perimenopause with GCS score over 20
- •BMI range between 18-35 kg/m2
- •Healthy woman
排除标准
- •Less than 40 years old
- •Diagnosed with diseases related to reproductive system such as PCOS or endometriosis
- •Taking anti-depressant medication or sleeping pills
- •Taking hormonal replacement therapy (HRT)
- •Taking conventional drug treatment or dietary supplementation
- •Having medical history or medical/surgical event in the last 6 months, or has been treated for cancer or any other ongoing treatment for the past 3 months,
- •Current and/or past history of hyper/hypotension, CVD, diabetes, autoimmune diseases, musculoskeletal disorder or endocrine or immunocompromised or neurological or psychological disorders,
- •Being medicated for these conditions,
- •History of allergic reactions to saffron intake,
- •Decisionally challenged subjects or unable to comply to the study
- •Any conditions that could contraindicates the use of saffron
- •Currently smoking or ceased smoking in the past 3 months
研究组 & 干预措施
Saffron extract supplementation (15mg, twice daily)
The experimental group will take a single capsule containing: 15mg of of saffron extract (stigma of the flower Crocus sativus), 340mg of Maltodextrin, encapsulated in hydroxypropyl methyl cellulose (HPMC), twice daily (one morning and one evening after the meal).
干预措施: Safr'Inside supplement (Activ'Inside, SAS) (Dietary Supplement)
Control group
The Control group will take a single placebo capsule (matched to the experimental intervention in terms of colours and taste, without the active compounds saffron) twice daily (one morning and one evening after the meal).
干预措施: Plcebo (Other)
结局指标
主要结局
Effect on overall perimenopause clinical symptoms severity
时间窗: 6-weeks, 12-weeks
Changes in Greene Climacteric Scale (GCS) score
次要结局
- Effect on mood(6-weeks, 12-weeks)
- Effect on sleep quality(6-weeks, 12-weeks)
- Effect on quality of life(6-weeks, 12-weeks)
- Exploratory measures(12-weeks)
研究者
Dr. Amjad Khan
Professor of Clinical Biochemistry and Experimental medicine
Liaquat University of Medical & Health Sciences