Open Labeled Single Arm Clinical Trail on Punarnavadi Guggulu in the management of Premenstrual Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To subside premenstrual symptoms
研究概览
简要总结
Premenstrual syndrome (PMS) encompasses a variety of emotional and physical symptoms that occur from several days to weeks before the onset of menstrual flow. Presently, Premenstrual syndrome is recognized as a psycho-neuroendocrine disorder of unknown etiology.
Symptoms disrupting the premenstrual period if left untreated may lead to PMDD-premenstrual dysphoric disease which is a more severe form of manifestation of the symptoms related to PMS may have disastrous effects in the form of suicidal thoughts, panic disorders, lack of interest in daily activities and relationships. This may have grave consequences on the socio-economic of life thereby reducing the qualiy of life of the patient.
Modern medicine has not zeroed in on a specific cause, but has suggested a number hypothesis to explain the possible pathophysiology. They are as under: Diminished progesterone levels, Decreased synthesis of serotonin, Withdrawal of endorphins from the brain during luteal phase, Reduced Gamma amino butyric acid levels.
By and large symptoms complex bears a similarity to the Samprapti of Shotha mentioned by Ayurvedic classics. The hypothesis therefore is formed that the drugs used in Shotha vyadhi would be helpful in terminating the Samprapti and alleviating the symptoms in PMS. The hypothesis is substantiated by the fact that the intervention drug chosen for this study- Punarnavadi guggulu from Shotha-adhikara of Bhaishajya Ratnawali is indeed found to be useful in treating PMS. It is therefore proposed to undertake this study to create an evidence for its usage by vaidyas.
Assessment criteria- PMTS-OR
Intervention - Punarnavadi Guggulu 4 tab (500mg each) twice a day with luke warm water, After meal, for 2 cycles and 1 cycle for observation
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
- •Age 18-40 years Irrespective of marrital status Regular cycle Symptoms should appear at definite time in luteal phase of the cycle.
排除标准
- •Women aged below 18 and above 40 years Diagnosed psychiatric disorder Irregular cycle Any organic pelvic pathology Any known major systemic illness Diabetes PCOS Metrorrhagia symptoms should not persist after 5 days of menstrual cycle symptoms shuold not reoccur within the 1st 13 days.
结局指标
主要结局
To subside premenstrual symptoms
时间窗: 30 days
次要结局
- relief in the symptoms of dysmenorrhea(30 days)
