Effect of Shuneez in premenstrual syndrome a randomized placebo controlled trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Improvement in PMSS, SDS Scales
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 menstrual cycle Women with more severe affective symptoms are classified as having premenstrual dysphoric disorder This disorder can manifest with a wide variety of symptoms including depression mood lability abdominal pain breast tenderness headache and fatigue Symptoms typically begin between the ages of 25 and 45 yearsThe prevalence of PMS has been reported in 20 to 32 of premenopausal and 30 to 40 of the reproductive female population Premenstrual syndrome is one of the most common disorder of reproductive age that can be seen in different intensities in 85-90 and about 5 of women experience severe symptoms that the symptoms interfere with their daily activities Nigella sativa shuneez kalonji has been considered for trial having mudirr i bawl wa hayd muhallil riyah musakkin muqqawi meda mullayan taba dafe nafakh shikam musakkin dard e shikam dafe istiskah etc Also it possesses many properties like immunopotentiation and antihistaminic antidiabetic anti hypertensive anti inflammatory and antimicrobial activities It is easily available cost effective and having less side effects Hence it has been selected to evaluate the effect in PMS
| Several scales are used to determine the |
| level of severity as well as the diagnosis of PMS The development of the |
| Premenstrual Syndrome Scale PMSS was based on DSM III and DSM IV R and is |
| a reliable scale for measuring the severity of premenstrual symptoms The |
| Sheehan Disability Scale SDS was originally designed to assess functional |
| impairment associated with anxiety disorder |
Shuneez Kalonji Nigella sativa has antiviral antioxidant anti inflammatory immunomodulatory broncho dilatory antihistaminic antitussive activities In addition it has also shown anti hypertensive anti obesity anti diabetic antih yperlipidemic anti ulcer and antineoplastic activities Black seeds have lots of volatile oils that hold strong anti inflammatory properties which manages abdominal spasm or cramps linked to menstruation
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 15.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- Female
入选标准
- •Regular cycle and a cycle length 21 35 days Symptoms of premenstrual syndrome such as anxiety depression irritability headache confusion insomnia mood swings abdominal bloating breast tenderness fatigue backache menstrual cramps starting from day 14 of previous menstrual cycle to day 1 of current menstrual cycle.
排除标准
- •Irregular cycle and any abdominal and pelvic pathology On hormonal replacement therapy oral contraceptives under gone hysterectomy Uncontrolled diabetes mellitus hypertension thyroid dysfunction Diagnosed cases of psychiatric disorder Lactating mother.
结局指标
主要结局
Improvement in PMSS, SDS Scales
时间窗: 0 30 days 60 days 90 days
次要结局
- Anxiety irritability depression confusion insomnia mood swings headache breast tenderness, abdominal bloating fatigue backache menstrual cramps(0 30 days 60days 90days)
研究者
Tabassum Bano
National institute of unani medicine