A randomized placebo controlled clinical study to evaluate the efficacy of Shweta jeeraka (Cuminum cyminum Linn.) in the management of Premenstrual syndrome.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Significant improvement in the symptoms of Premenstrual syndrome.
研究概览
简要总结
Premenstrual syndrome, a common cyclic disorder of young and middle aged women, is characterized by emotional and physical symptoms that consistently occur during the luteal phase of the menstrual cycle. It is a complex cluster of symptoms that occur 7 to 14 days prior to menses and ends after the onset of menses.
The WHO International classification of diseases (ICD - 11) includes premenstrual tension syndrome under the heading diseases of genitourinary tract. It is also known as Premenstrual tension (PMT) and premenstrual stress.
The pooled prevalence of reproductive age women affected with PMS worldwide amounts to 47.8%. Among these, about 20% of women experience symptoms severe enough to disrupt their daily activities, and the remaining have mild to moderate symptoms and Prevalence rate of PMS in India as obtained from the total 25 studies conducted between 2000 to 2020 is around 43%.
Though the PMS is of unknown aetiology, there are theories stating to be influenced by several factors like stress, improper diet and lifestyele.
The management of Premenstrual Syndrome (PMS) often involves a combination of pyridoxine (vitamin B6), hormonal treatments, and antidepressants. While these can be effective, they may also lead to side effects such as peripheral neuropathy, nausea, insomnia and early menopause.
Symptoms of premenstrual syndrome are irritability, anxiety, mood swings, tearfulness, breast tenderness and bloating of abdomen.
Shweta Jeeraka (Cuminum cyminum Linn.) is one of the important drug mentioned in Ayurveda classics which has the properties like Medhya, Hridya, Garbhashaya Vishodhaka and *Adhmanahara.*It is also a spice commonly used in the Indian kitchen, well known for its action in various diseases like indigestion, diarrhoea and gynaecological diseases.
Considering the above properties, it is worthwhile to evaluate the efficacy of Shweta Jeeraka (Cuminum cyminum Linn.) in the management of Premenstrual syndrome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Subjects between age group of 20 to 40 years, irrespective of their marital status.
- •2.Subjects presenting with mild to moderate symptoms of Premenstrual syndrome (PMS) with regular menstrual cycle.
- •3.Subjects who are willing to give written consent for the study.
排除标准
- •1.Subjects with irregular menstruation.
- •2.Subjects undergoing hormone therapy.
- •3.Subjects under alcohol use or any other substance abuse.
- •4.Subjects exhibiting symptoms continuous throughout the phase of menstrual cycle.
- •Subjects with underlying pathological conditions of breast and pelvis.
- •Subjects with Premenstrual Dysphoric Disorder (PMDD) and any pre-existing psychological disorder.
结局指标
主要结局
Significant improvement in the symptoms of Premenstrual syndrome.
时间窗: 1st assessment (BT)- 0th day | 2nd assessment -5th day of the first cycle | 3rd assessment - 5th day of the second cycle | 4th assessment- 5th day of the third cycle | 5th assessment (drug free)- 5th day of the fourth cycle
次要结局
- Improvement in quality of life(Generation of in-depth analysed data on the different aspects of the disease.)