A comparative clinical study to evaluate the efficacy of Shatapushpa Taila Nasya in Proliferative and Secretory phases of menstrual cycle in Udavarta Yonivyapat W.S.R. to Primary Dysmenorrhea.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 1.WaLIDD Score for working ability, intensity of pain, duration of pain asssessment
研究概览
简要总结
Ayurveda is accepted as one of the oldest traditional systems of medicine worldwide. In ayurvedic classics, majority of gynaecological disorders have been discussed under Yonivyapat. Udavarta Yonivyapat is one among Vataja Yonivyapat. Due to Nidanas, the Vata Dosha gets vitiated and moved upwards, produces Raja Kruchrena Munjathi (difficult or painful menstruation) and Vedana (Generalised body aches)
Dysmenorrhea is a common menstrual complaint with major impact on women quality of life. The prevalence of dysmenorrhea varies between 16% and 91% in women of reproductive age.Dysmenorrhea means painful menstruation of sufficient magnitude so as to incapacitate day-to-day activities. Primary dysmenorrhea is where there is no pelvic pathology and is caused by psychosomatic factors (tension, stress), increased prostaglandins and vasopressin. Symptoms includes spasmodic pain in lower abdomen, nausea, vomiting, fatigue, diarrhoea, headache. The line of management includes analgesics, antispasmodics, prostaglandins synthetase inhibitors, oral contraceptives and surgery as last resort. These modalities have adverse side effects like dizziness, depression, vertigo, etc. Hence, there is a need to find safe, potent solution for dysmenorrhea.
Vamanadi Karmas like Vamana, Virechana, Anuvasana, Asthapana Basti and Nasya are mentioned as Samanya Chikitsa after proper Snehana and Swedana for all Yonivyapat. As Udavarta Yonivyapat is one among Yonivyapat, the same line of treatment can be considered. Under Panchakarma, Nasya has its action on Shiras as nose is the closest opening for conveying the potency of medicines to cranial cavity, hypothalamus secrets vasopressin and is responsible for expression of pain, stress factors. Thus, Nasya can be considered as a potential treatment modality for dysmenorrhea.
Acharya Kashyapa indicated Shatapushpa Taila Nasya in Vandyatva, which is a type of Vataja Yonivyapat and Udavarta Yonivyapat being a type of Vataja Yonivyapat, Shatapushpa Taila Nasya is considered for the study. Shatapushpa is having properties like Madhura, Balya, Brhmana, Pushti-Varna-Agni Vardhana, Rtupravartana, Yonishukra Vishodana, Ushna and Vatahara. And, Shatapushpa relives dysmenorrhea due to inhibition of prostaglandin production and antispasmodic action.
Luteal-phase human endometrium from dysmenorrheic women has been shown in vitro to produce seven times more prostaglandin F2α than luteal phase endometrium of normal women.So here in this study an attempt is made to compare the efficacy of Shatapushpa Taila Nasya in Proliferative and Secretory phase of menstrual cycle in Udavarta Yonivyapat
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
- 12.00 Year(s) 至 50.00 Year(s)(—)
- 性别
- Female
入选标准
- •Women having the classical Lakshanas of Udavarta Yonivyapat and symptoms of Primary dysmenorrhea.
- •Women who are Nasya Yogya according to Ayurveda Classics irrespective of occupation and socio-economic status.
- •Women in between 12 years and 50 years of age.
排除标准
- •Women who are Nasya Ayogya according to Ayurveda Classics.
- •Patients with the association of other disorders like fibroid, endometriosis, PID etc.
- •Patients below age of 12 years and above 50 years.
结局指标
主要结局
1.WaLIDD Score for working ability, intensity of pain, duration of pain asssessment
时间窗: 0th day, 1st cycle, 2nd cycle, 3rd menstrual cycle after Nasya Karma(Days cannot be specified as the menstrual cycle may varry between 28 to 35 days)
2. Multidimensional scoring system of dysmenorrhea for assessment of severity of pain, systemic symptoms involved
时间窗: 0th day, 1st cycle, 2nd cycle, 3rd menstrual cycle after Nasya Karma(Days cannot be specified as the menstrual cycle may varry between 28 to 35 days)
次要结局
未报告次要终点
研究者
Dr Bhagyavathi S
KVG Ayurveda Medical College and Hospital,
