A single blind randomized comparative clinical trial to evaluate the efficacy of Panchkola Arka and Chaturbeeja Arka in the management of Udavartini Yonivyapad (Primary Dysmenorrhea)
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 80 % reduction in scoring of WALIDD
研究概览
简要总结
Primary Dysmenorrhea is the most common gynaecological problem that faced by women during their adolescence and is a common problem of the females in the reproductive age group. It is the spasmodic pain that confined to the lower abdomen and may radiate to the back and medial aspects of thighs without any pelvic pathology. Primary dysmenorrhea can be correlated with Udavartini Yonivyapad of Acharya Charaka or Udavarta of Acharya Sushruta.This trial is to evaluate and compare the efficacy of Panchkola Arka and Chaturbeeja Arka in the management of Udavartini Yonivyapad (Primary Dysmenorrhea). The trial will be performed in two groups one will be given Panchkola Arka and second will be given Chaturbeeja Arka .To avoid biasness investigator will be blinded in the study hence it a single blind study. Both the arka will be given in 10ml bd dose from 5 days prior to mensturation till 2nd day of periods. The observation and result will be analysed statistically with relevant tests and level of significance will be reported .Primary outcome will be - Reduction in scoring of WALIDD,80 % of reduction (Baseline and 3rd menstrual cycle) and secondary expected outcome will be: Reduction in associated symptoms i.e. nausea, vomiting, headache etc.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 30.00 Year(s)(—)
- 性别
- Female
入选标准
- •Subjects fulfilling the diagnostic criteria Subjects of Age group 18 to 30 years Married and unmarried women Subjects with regular menstrual cycles with the interval of 24 to 38 days History of painful menstruation for atleast 3 consecutive cycles Subjects without any structural pelvic pathology.
排除标准
- •Subjects experiencing menstrual pain attributed to underlying pelvic pathology diagnosed by USG like uterine fibroids adenomyosis endometriosis etc Subjects with Intrauterine contraceptive devices IUCDs Subjects with uncontrolled diabetes hypothyroidism and hypertension Subjects with a history of undiagnosed irregular vaginal bleeding Subjects who habitually consume analgesics antispasmodics sedatives or muscle relaxants within 48 hours before expected menstrual periods Subjects on Progesterone or Estrogen Pills Subjects with any structural pelvic pathology.
结局指标
主要结局
80 % reduction in scoring of WALIDD
时间窗: from 0th to 90th day
次要结局
- Reduction in associated symptoms(from 0th to 90th day)
研究者
DR SHIVANI SHARDA
Shri dhanwantry ayurvedic college and hospital
