A single arm interventional study to determine the effectiveness of daily consumption of modaka prepared with krishna tila, marayoor jaggery and trikatu in subjects diagnosed with arthava kshaya
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- 50% reduction in pain scale
研究概览
简要总结
Menstrual abnormalities are quiet common in adolescent age . This leads to emotional stress to the adolescent girls. According to recent statistics, 75% of girls are experiencing problems associated with menstruation. The major abnormalities are dysmenorrhea, premenstrual syndrome (PMS), and menstrual irregularities. These disorders may lead to problems in daily activities such as academic excellence, achievements in sports, and loss of self-confidence. Present study aims to determine the effectiveness of daily consumption of modaka prepared with krishna tila, marayoor jaggery and trikatu in subjects diagnosed with oligomenorrhea or artava kshaya. This study is an open labelled single arm clinical trial. Primary outcome will be reduction in lengthy cycles and painful bleeding.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 25.00 Year(s)（—）
- 性别
- Female
入选标准
- •Girls who are having irregular lengthy menstrual cycles along with painful scanty bleeding and those who have given consent will be recruited into the study.
排除标准
- •Girls who are having thyroid dysfunction, pituitary dysfunction , adrenal gland dysfunction and those who are undergoing infertility treatment will be excluded.
结局指标
主要结局
50% reduction in pain scale
时间窗: base line - initial menstrual pain scale assessment | 4 weeks - expected to reduce by 25% | 8 weeks - expected to reduce by 50%
次要结局
- Regular menstrual cycle(8 weeks)
研究者
Dr Indu V L
Kerala University Of Health Sciences