An open Double arm Randomized Comparative Clinical trial toEvaluate and Compare the Efficacy of Siddha herbal formulationsKalingadhy thailam and Inji Churanam in reducing pain among theReproductive age group with Dhoorasoolai (Primary dysmenorrheaNSMC Code: ZAA1.8) at SCRI OPD Chennai- A pilot study.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The primary outcome measures will be evaluating and comparing the efficacy of kalingadhy thailam and Inchi choornam in reducing pain among women with Dhoora soolai (Primary Dysmennorhea) by using WaLLID tool
研究概览
简要总结
This is an Interventional study to evaluate and compare the efficacy of two Siddha formulations. Adolescence is the transitional period marked with the onset of menarche an important milestone which is often associated with problems of irregular menstruation, excessive bleeding and dysmenorrhea. Current evidence suggests that dysmenorrhea happen due to myometrial contraction resulting from secretion of prostaglandin during secretary phase of endometrium. Primary aim of the study is to evaluate and compare the efficacy of kalingadhy thailam and Inji choornam in reducing pain among women in Reproductive age group with primary dysmenorrhea. menstrual pain will be assessed using WaLLID tool. Secondary aim is to assess the safety and status of Hormones after the administration of Kalingadhy thailam and Inji choornam. Prostaglandin F2 alpha will be measured in both venous blood and Menstrual blood.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- Female
入选标准
- •1 Trial participants who are at the age group of 18-35 years 2 Menstrual pain for more than 3 consecutive regular menstrual cycle without pelvic organ pathology 3 Complaints of primary dysmenorrhea from menarche or shortly after (6–24 months) menarche.
- •4 Regular menstrual cycle of 24 to 32 days 5 Severe dysmenorrhea with 8-12 score using WaLLID tool.
排除标准
- •1 Study participants who have pelvic inflammatory diseases 2 Irregular menstrual cycle 3 Secondary dysmenorrhea associated with ovarian cyst, endometriosis and fibroid (excluded clinically and radio logically) 4 Pain abdomen associated with excessive BPV 5 Having oral contraceptive pills and IUCD (Intrauterine contraceptive pills) 6 Who are under the treatment of hormonal therapy 7 who are pregnant/planning to pregnant, Lactating mother.
结局指标
主要结局
The primary outcome measures will be evaluating and comparing the efficacy of kalingadhy thailam and Inchi choornam in reducing pain among women with Dhoora soolai (Primary Dysmennorhea) by using WaLLID tool
时间窗: Baseline and 3rd day of every month of intervention and follow up | totally 6 months
次要结局
- Measuring the status of hormones before and after the administration of trial drugs.(Measuring safety of the trial drug kalingadhy thailam)