Efficacy of dietary intervention of Flaxseeds(Linum usitatissimum) on signs and symptoms associated with Perimenopausal Syndrome
试验速览
- 阶段
- 2/3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Significant Changes in menopausal symptom score according to
研究概览
简要总结
This study is a randomized single-blind placebo controlled trial, to assess the effect of dietary intervention of flaxseeds(10gm) in comparison with placebo(roasted wheat flour-10gm) daily, on sign and symptoms associated with Perimenopausal Syndrome for 3 months in 120 patients(Treatment group-60 and Placebo group-60). Patients will be recruited from OPD of Queen Mary’s, Department of Obstetrics and Gynecology, King George’s Medical University and near by areas. Primary Outcome measured will be significant changes in menopausal symptoms score by Modified Kupperman’s Index Score, Menopause Rating Scale and MENQOL Intervention Questionnaire score after 3 months. Secondary outcome measured will be the levels of lignans Enterolactone(ENL) and Enterodiol(END) and Estradiol hormone after 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 40.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- Female
入选标准
- •Subjects according to the guidelines of Indian Menopause Society, FSH level should be >20 IU/ml with Vasomotor symptoms even in the absence of cessation of menstruation 2)Age should be between 40 to 55 years 3)Not under medication (estrogen and phytoestrogen).
排除标准
- •Surgical menopause, hysterectomy, abnormal anatomical structures of the uterus or ovaries 2) Use of HRT, SSRIs (selective serotonin reuptake inhibitors) 3) History of malignancy, mental disorders including depression), thyroid diseases 4) With heart, liver or kidney diseases 5) Use of sedative or anti-anxiety drugs, Cigarette smoking, alcohol or drug abuse 6)Participation in other clinical trials.
结局指标
主要结局
Significant Changes in menopausal symptom score according to
时间窗: Significant changes in menopausal symptom score | Modified Kuppermans Index Score at Baseline,12 weeks | Menopause Rating Scale at baseline, 12 weeks | MENQOL Intervention questionnaire score at baseline, 12 weeks
MENQOL Intervention questionnaire score assessment
时间窗: Significant changes in menopausal symptom score | Modified Kuppermans Index Score at Baseline,12 weeks | Menopause Rating Scale at baseline, 12 weeks | MENQOL Intervention questionnaire score at baseline, 12 weeks
Modified Kuppermans Index Score greater than 6
时间窗: Significant changes in menopausal symptom score | Modified Kuppermans Index Score at Baseline,12 weeks | Menopause Rating Scale at baseline, 12 weeks | MENQOL Intervention questionnaire score at baseline, 12 weeks
Menopause Rating Scale greater than 4
时间窗: Significant changes in menopausal symptom score | Modified Kuppermans Index Score at Baseline,12 weeks | Menopause Rating Scale at baseline, 12 weeks | MENQOL Intervention questionnaire score at baseline, 12 weeks
次要结局
- Levels of lignans and hormones before and after dietary intervention(Enterolactone (ENL))