CTRI/2021/08/035334尚未招募3 期
A prospective community based study for the evaluation of Rajapravartani Vati in the Management of Primary Dysmenorrhoea
Central Council for Research in Ayurvedic Sciences CCRAS10 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年4月8日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 10
- 主要终点
- i.Change in Visual Analog Scale (VAS) for pain.
研究概览
简要总结
The study is a prospective community based study for the evaluation of clinical effects of Rajapravartani vati in the management of Primary Dysmenorrhoea. It is a single arm trial with a sample size of 50 at each partcipating center (total 10 CCRAS centers). The outcome measures are VAS Score and WaLLIDD score.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 25.00 Year(s)（—）
- 性别
- Female
入选标准
- •i.Young women of age 18 -25 years of scheduled Caste community ii.Self-reported history consistent with primary dysmenorrheal of moderate to severe nature (Mild: doesn’t interfere in normal activities, Moderate: slightly interferes in daily routines but can be managed by painkillers, Severe: markedly prevents daily life activities) with a self-reported menstrual cycle of averaging 21-35 days.
- •iii.Willing and able to participate in the study (Written informed consent or assent).
排除标准
- •i.Irregular Cycles.
- •ii.Cases of secondary Dysmenorrhea iii.Pain abdomen associated with excessive bleeding per vagina.
- •iv.Presence of persistent pelvic pain throughout the menstrual cycle.
- •v.Known case / diagnosis /h/o of leiomyoma of uterus, ovarian cyst, endometriosis.
- •vi.Associated with clinically diagnosed pelvic inflammatory disease (PID), vii.Associated with any pre-diagnosed or clinically diagnosed systemic disorders likely to influence menstrual cycle.
- •viii.Patients with Hb ≤ 7 gm % ix.History of malignancy of pelvic organs.
- •x.Diagnosed cases Hypo/hyperthyroidism.
- •xi.Woman using IUD / Oral Contraceptive Pills (OCP) xii.Patient co morbid with systemic diseases like diabetes mellitus, hypertension, cardiac/ Renal/ Pulmonary/ Hepatic disorders.
- •xiii.Women who are planning to conceive in the next 6 months.
- •xiv.Participation in other concomitant therapy for acute or chronic pain.
结局指标
主要结局
i.Change in Visual Analog Scale (VAS) for pain.
时间窗: At baseline, after 1 month, after 2 months, after 3 months and after 4 months.
次要结局
- i.Changes in total WaLLID score.(ii.Change in Hb status of the subject from the baseline to the end of trial -12 weeks.)
研究者
研究点 (10)
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