An open label randomized comparative clinical trial to evaluate the efficacy of Nasya with Kshirbala Taila (101 Avarthi ) and Mahanarayana Taila in Anovulation
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
- Ovulation
研究概览
简要总结
Anovulation is the failure to release an oocyte from a mature Graafian follicle. Anovulation is one of common causes of infertility. The hypothalamic-pituitary-ovarian axis disturbance can be responsible for anovulation. This trial is to evaluate and compare the effect of Nasya with Kshirbala Taila (101 Avarthi) and Mahanarayana Taila in managing annovulation and irregular intervals of menstrual cycle. The trial will be performed in two groups consisting of 30 patients in each group. One group will be given Nasya with Kshirbala Taila (101 Avarthi) and the second group will be given nasya with Mahanarayana Taila. The dose for Nasya in both groups will be 8 drops per day in each nostril for 7days after cessation of menses , then following break of 3 days , again Nasya is to be taken for 7 days in same dose. The primary expected outcome will be ovulation whereas secondary expected outcome will be menstrual cycle regularity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •Married female subjects of age group between 18 to 40 years.Subjects with full consent for participation in the clinical trial.Subjects with history of regular cycle (24 to 38 days) and irregular cycle more than 38-90 days fulfilling diagnostic criteria.
排除标准
- •â€¢Hyperthyroidism, uncontrolled hypothyroidism •Subjects on hormone (estrogen & progesterone) pills •Subjects on ovulation induction •Subjects having history of diabetes mellitus, hypertension •Subjects with congenital disease •Subjects having any pelvic pathologies like uterine fibroid, adenomyosis, endometriosis, pelvic inflammatory diseases •Ovarian tumors •Hyperprolactinemia with serum prolactin more than 50ng/ml •Obesity with BMI more than 30.
结局指标
主要结局
Ovulation
时间窗: baseline to 3rd menstrual cycle
次要结局
- Menstraul cycle regularity(baseline to 90th day)
研究者
Dr Mona Rani
Shri Dhanwantry Ayurvedic College and hospital sector 46 B Chandigarh