An open label clinical trial to evaluate the efficacy of Sundari Jeevak syrup in the management of Kashtartava (Primary dysmenorrhea)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Changes pain (Primary dysmenorrhea).
研究概览
简要总结
It is an open labeled, single armed, single center, prospective, interventional clinical study to evaluate the efficacy of the Sundari Jeevak syrup on 50 patients suffering from Kashtartava (Primary dysmenorrhea). The study will be conducted in Panchakarma department, NIA, Jaipur, Rajasthan. It will be advised to subjects to Sundari Jeevak syrup will be given, 14 days after menstruation till the commencement of next cycle for two consecutive cycles. The primary outcome measure will be to assess the efficacy Sundari Jeevak syrup in patients of Kashtartava (Dysmenorrhea) by assessing the Changes pain and duration of pain during menstruation. The secondary outcome will be assess the changes in associated symptoms likenausea, Chhardi, Vibandha, Atisara, Shrama, Aruchi, Shirasula etc
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 16.00 Year(s) 至 30.00 Year(s)（—）
- 性别
- Female
入选标准
- •Females suffering from primary dysmenorrhea more than 3 consecutive cycles.
- •Female presenting primary dysmenorrhea with or without any of the following symptoms associated with- Any kind of pain like headache, backache, abdominal pain, body ache, Nausea and vomiting, Weakness.
- •Psychological symptoms- like anxiety, stress, depression, irritability, restlessness.
- •4.Willing to participate in the trial.
- •5.Readiness to sign an informed consent form.
排除标准
- •Patients having congenital anomalies, patient is suffering from acute infections, cervical stenosis etc.
- •Patients with chronic illness, patient using an intrauterine contraceptive device, and patient with menorrhagia or any uterine pathology (fibroid, adenomyosis, endometriosis etc.) will be excluded from the study.
- •Lactating female.
- •Individuals participating in any other clinical trial.
结局指标
主要结局
Changes pain (Primary dysmenorrhea).
时间窗: 90 days
次要结局
- Changes in associated symptoms(90 days)