Open labeled interventional clinical trial to evaluate effect of Asthipohak Vati tablet in the management of Premenstrual Syndrome(PMS)
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Improvement in the clinical features and relief of PMS
研究概览
简要总结
Premenstrual syndrome is recognized as a psycho-neuro-endocrine disorder of unknown aeitiology PMS encompasses a wide variety of emotional and physical symptoms that occur from several days to week before the onset of menstrual flow. Various hypotheses are postulated to explain the etiopathogenesis of PMS
Evidence strongly suggests that calcium and vitamin D deficiency and alteration in the metabolism of calcium and vitamin D are responsible for these luteal phase symptoms
In the present study propreitary medicine asthiposhak vati which is known to relieve symptoms related to calcium deficiency, is selected for the management of PMS It may have a positive effect on the calcium metabolism and thereby alter the pathology of PMS.
Patients will be asses ed on the basis of
1 PMS self rating scale
2.PMS Observer rating scale
- PMS Vas scale
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •1 Subjects irrespective of their marital status 2 Women with regular cycle with symptoms of pre- menstrual syndrome, at around 25th day onwards of menstrual cycle, with symptoms extending not beyond 5th day of subsequent menstrual cycle.
- •3 Women having a minimum PMTS score greater than or equal to 10 and VAS score greater than or equal to 1 4 Be able and willing in the view of the investigator to comply with all study procedures.
排除标准
- •1 Subjects aged above 40 years 2 Unmarried or married subjects with irregular cycles 3 Pregnant women 4 Subjects on any type of OC Pills hormone containing medication since past 6 months IUCD ovulation induction or menstrual regularizers-since past 6 months 5 Subjects with chronic debilitating ailments and on cortico steroid therapy 6 Women with history of PID endometriosis and debilitating pathological conditions of the pelvic organs systemic diseases like diabetes mellitus bronchial asthma tuberculosis thyroid dysfunction with organic lesion benign or malignant growth of reproductive tract any degree of uterine prolapse and hypo-plastic uterus 7 Women with congenital anomalies of genital organs 8 Subjects with history of or diagnosed cases of psychosomatic ailments, Cognitive disorders, psychosis or neurosis, personality disorders 9 Women with Urinary calculus 10 Women taking any concomitant medicine for PMS will be excluded from the study.
结局指标
主要结局
Improvement in the clinical features and relief of PMS
时间窗: The outcomes will be measured after screening at Base Line (BT) after 1 month and at the end of 2 months AT Assessment of clinical parameters will also be done at the end of the 3rd month after 1 month of medicine free period
次要结局
- Relief in pain in premenstrual period(Improvements in low back ache constipation)