A Randomized Controlled Trial to Evaluate the Effect of Lifestyle Modifications in Asrigdara
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- changes in assessment criteria
研究概览
简要总结
Need of Study:Asrigdara is very much common in clinical practices. In modern it is related with AUB having prevalence is estimated to be 30% .In India, the reported prevalence of Asrigdara(AUB) is around 17.9%.
Females are very much suffered due to this disease physically and psychologically. Other contemporary system medicines not provided sufficient patient friendly ways to reduce or cure this problem.
Conditions cannot be corrected until the lifestyle is not modified which is the root cause in most of the cases . Lifestyle modifications are easy to follow, easily acceptable and cost effective as well as goes with daily routine easily.
Not any such type of work has been done till now, so it can provide another treatment option for this disease.
Lifestyle modifications correct the hormonal secretions at various levels and improve the metabolism which is very much needed in this disease.
Aim and Objectives:
Aim: Clinical Evaluation of Lifestyle Modifications in Asrigdara
Objectives: Evaluation of the effect of Lifestyle Modifications in the terms of Dinacharya, Aahar and Yoga in Asrigdara through a Randomized Controlled Trial
Research Question: Are Lifestyle Modifications effective in Asrigdara?
Null Hypothesis: There is no effect of Lifestyle Modifications in Asrigdara.
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
- 12.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- Female
入选标准
- •Women between age group 12 to 50 years both married and Unmarried Patients having any one or two of the following features will be included Heavy menstrual bleeding Prolonged menstrual bleeding Intermenstrual bleeding Hb percent equal to or more than 8gm dl Patients with excessive bleeding for at least two consecutive cycles.
排除标准
- •Patients with bleeding diathesis Pregnancy Patients using drugs that may cause vaginal bleeding patients with any organic pathology to explain the bleeding in gynecological examination Patients using IUCD and OCP Bleeding followed by abortion Any systemic disease History of reproductive system disorder like organic pelvic pathology benign and malignant tumours PID congenital anomalies of genital tract and different types of infections.
结局指标
主要结局
changes in assessment criteria
时间窗: at base line 30 days 60 days
Assessment Criteria
时间窗: at base line 30 days 60 days
Asirgdar is assessed by on the basis of following criteria:
时间窗: at base line 30 days 60 days
Atyadhik matra Heavy amount of menstrual blood
时间窗: at base line 30 days 60 days
Atyadhik kaal Menstrual phase is more than normal
时间窗: at base line 30 days 60 days
Anritukala pravritti Menstrual blood flow other than cycle or between cycle
时间窗: at base line 30 days 60 days
次要结局
未报告次要终点
研究者
Dr Durgawati Devi
National Institute of Ayurveda Jaipur Rajasthan