ANIRVID: A multi-center study to evaluatethe effect of complimentary alternative interventions on perinatal depression and itsassociated heart and thyroid function using conventional techniques, metabolomicsand point of care device.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 600
- 试验地点
- 3
- 主要终点
- Biomarker based point-of-care device to monitor perinatal depression, cardiac and thyroid functions, mainly in resource limited settings
研究概览
简要总结
Perinatal depression is highly prevalent and isa major public health issue as it affects both the mother and the newborn. Inaddition, several study findings implicate depression as one of the causativefactors for cardiovascular disease and thyroid disorders. Therefore, earlydetection of depression is necessary for the benefit of both mother and child.The main goal of this proposed multi-center study is to develop a more rapid,hand-held, mobile-health point-of-care (POC) diagnostic device - ‘Anirvid’ formonitoring key biomarkers related to perinatal depression and its relateddisorders at low-cost than current existing systems. In addition, the efficacyof drugs-free complementary and alternative interventions on perinatal depressionand its associated cardiac and thyroid functions will also be studied using‘Sai Vibrionics’ and ‘Primordial Chanting.’ Therefore, the proposed study willfacilitate early diagnosis, prognosis and modification in the management ofperinatal depression for the benefit of pregnant women and mothers in thesociety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)(—)
- 性别
- Female
入选标准
- •Pregnant Women in the age: ≥18 years and ≤40 years.
排除标准
- •Pregnant women who are already on psychotropic medication; and Pregnant women who are already taking any complementary and alternative interventions.
结局指标
主要结局
Biomarker based point-of-care device to monitor perinatal depression, cardiac and thyroid functions, mainly in resource limited settings
时间窗: 3 years
Use of simple, effective, drug-free and cost-effective complementary and alternative medicine for pregnant women
时间窗: 3 years
次要结局
- This study will facilitate the early diagnosis and management of depression and its related disorders in pregnant women and mothers(3 years)
