CTRI/2024/03/064639尚未招募2 期
Clinical Assessment of DMH Syrup and DMH Tablets in Pre-menstrual Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Reduction in psychological and somatic symptoms of premenstrual syndrome like Irritability, Mood swings, Periodic cramps after the administration of DMH syrup and DMH tablet after 90 days
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 19.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Provision of signed and dated informed consent prior to any study-specific procedures.
- •Healthy females in the age group of 19-45 years with a history of psychological or somatic signs and symptoms of Pre-menstrual syndrome (PMS)
- •Females with regular menstrual cycles of 21-35 days (based on history)
- •Not on any hormonal therapy during and one month prior to the trial.
- •Willing to practice birth control methods other than hormonal contraception (barrier/condoms) during study period (as applicable)
- •Willing to follow study related procedures.
排除标准
- •Gynaecological conditions like history of any malignancy or organic lesions like genital tuberculosis, polyps, fibroids, endometriosis etc.Patients presenting with irregular menstrual cycle.Currently pregnant or breastfeeding.Planning pregnancy in next 3-4 months.Not willing to practice birth control methods other than hormonal contraception (oral contraceptive pill) during the course of the trial.Requirements of any prohibited concomitant medications (Oestrogen/Progesterone/ etc).
结局指标
主要结局
Reduction in psychological and somatic symptoms of premenstrual syndrome like Irritability, Mood swings, Periodic cramps after the administration of DMH syrup and DMH tablet after 90 days
时间窗: 90 days
次要结局
- To evaluate the impact of DMH syrup & tablet on change in Qol of women with Pre-menstrual syndrome(Improvement in lab parameters like CBC (ESR), Hormonal Levels & Urinalysis (assessed from Baseline to End of Study))
研究者
Dr Anupama V
Sri Kalabyraveshwara Swamy Ayurvedic Medical College And Research Centre Bangalore
研究点 (1)
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