A Novel Approach to Manipulate Intestinal Homeostasis in Primary Dysmenorrhoea Women: a Randomised Controlled Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- severity score before treatment (verbal rating score)
研究概览
简要总结
This study compares the effect of probiotics versus placebo in women with primary dysmenorrhoea
详细描述
This is a randomized controlled trial comparing probiotics against placebo in women with primary dysmenorrhoea
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
placebo and probiotic are labelled A or B, this is prepared by the manufacturer and blinded from the participant and investigator, the unblinding takes place only after completion of the data collection
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •regular menstrual cycles between 21 to 45 days
- •primary dysmenorrhoea only
- •willing to consume sachets twice daily for 3 months
排除标准
- •current Intrauterine Copper Device (IUCD) user
- •recent hormonal (estrogen or progesterone) therapy in last 3 months
- •on treatment for allergy such as antihistamine
- •diarrhoea with dairy product
- •often take drugs which may affect the test results (such as medicines treating constipation or digestive medicine such as laxatives or enema)
- •any malignant tumor regardless of type or site
结局指标
主要结局
severity score before treatment (verbal rating score)
时间窗: baseline
mean Verbal Rating Score on scale 0 to 3, on day 2 of menses at baseline
Quality of life after treatment (physical and mental health score assessed by SF12v2 questionnaire)
时间窗: at 3 months after completed treatment with probiotic or placebo
mean quality of life score using validated health survey questionnaire Short Form 12 version 2 (SF12v2) (permission obtained from primary author) Answers from each question will be calculated using formula into percentage of average physical health score and average mental health score, on scale 0 to 100 in which higher percentage represents higher quality of life, and score less than 50 represents poor quality of life
pain score before treatment (visual analog scale VAS)
时间窗: baseline
mean Visual Analog Score on scale 0 to 10, on day 2 of menses at baseline
Quality of life before treatment (Physical and mental health score assessed by SF12v2 questionnaire)
时间窗: baseline
mean quality of life score using validated health survey questionnaire Short Form 12 version 2 (SF12v2) (permission obtained from primary author) Answers from each question will be calculated using formula into percentage of average physical health score and average mental health score, on scale 0 to 100 in which higher percentage represents higher quality of life, and score less than 50 represents poor quality of life
Frequency of Non-steroidal Anti-Inflammatory Drugs (NSAIDs) use between placebo and probiotic group
时间窗: 3 months during treatment with probiotic or placebo
mean number of Non-steroidal Anti-Inflammatory Drugs (NSAIDs) use per cycle
pain score after treatment (visual analog scale VAS)
时间窗: after 3 months of treatment
mean Visual Analog Score on scale 0 to 10, on day 2 of menses after 3 months of treatment with probiotic/placebo
severity score after treatment (verbal rating score)
时间窗: after 3 months of treatment
mean Verbal Rating Score on scale 0 to 3, on day 2 of menses after 3 months of treatment with placebo/probiotic
次要结局
- Concentration of inflammatory markers post-treatment(At 3 months after commencement of treatment)
- intestinal microbiota before and after treatment with probiotics(on date of randomization and at 3 month after completed treatment with probiotic or placebo)
- Concentration of inflammatory markers pre-treatment(baseline)
研究者
Prof Dr Nur Azurah Abd Ghani
Professor
National University of Malaysia