A clinical study to assess the effect of selected yogasanas and shodhita hingu in the prevention of dysmenorrheic episodes- an open label double arm comparative clinical study.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Reduction in the intensity & duration of pain in Primary Dysmenorrhea
研究概览
简要总结
Primary dysmenorrhea refers to pain that is not associated with any identifiable pelvic pathology. It is characterized by pain in the lower abdomen that may radiate to the thighs and lower back. Associated problems include nausea, vomiting, mood swings, headache, fatigue, diarrhea, constipation etc.Dysmenorrhea can be co related with kashtartava in Ayurveda. Apana Vata Dushti is considered as main cause for kashtartava .So we are using Shodhita Hingu as it is having Vatashamaka, Shoola Prashamana, Agnivardaka and Vatanulomana properties and Yogasanas which are non- phamancological, cost-effective and safe intervention useful in treating Primary Dysmenorrhea. Even slight reduce in the intensity of pain makes a big difference for the patient and the routine life of that individual will greatly differ. Hence, the present study is taken which is aimed to find the effect of Selected Yoga Techniques and Shodhitha Hingu in Primary dysmenorrhea. In this study 60 female subjects diagnosed with Primary Dysmenorrhea will be randomly allocated into 2 groups, Group A-30 subjects and Group B- 30 subjects
Intervention of the study:
GROUP A:-Yogasanas will be demonstrated and asked to perform by the subjects
Asanas: Bhadrasana, Pavanamuktasana, Bhujangasama at morning
Medication: Shodhita Hingu should be consumed along with first bolus of the food(breakfast) for 30days
Dose:250mg
GROUP B
Medication: Shodhita Hingu should be consumed along with first bolus of the food
Dose:250mg
Duration-30 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 28.00 Year(s)（—）
- 性别
- Female
入选标准
- •Subjects fulfilling the diagnostic criteria.
- •Age between 18-28 years.
- •Known case of Dysmenorrhea for 4 consecutive cycles.
- •Subjects with regular menstrual cycles.
排除标准
- •Known case of Secondary Dysmenorrhea.
- •Subjects on hormonal therapy.
- •Subjects who are not willing to do Yoga.
结局指标
主要结局
Reduction in the intensity & duration of pain in Primary Dysmenorrhea
时间窗: on 0th day,60th day and 90th day
次要结局
- Absence of pain for 2-3 cosecutive cycles(3 months)