The Efficacy of Ayurved Siriraj Prasaplai for Treatment Primary Dysmenorrhea
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Pain score between experimental and placebo group
研究概览
简要总结
Ayurved Siriraj Prasaplai is a Thai traditional herbal drug for pain treatment. Mostly it was used for antipain during menstruation or dysmenorrhea. This drug has been described by alternative medical doctor for treatment of primary dysmenorrhea for more than 10 years and showed clinical satisfied response. From review about this agent, it does not have clinical trial to prove its efficacy. So the author produce this research to study in efficacy of Ayurved Siriraj Prasaplai.
详细描述
The participants were allocated in the study by block randomization and double blind. In experiment-group was treated with Ayurved Siriraj Prasaplai and control-group was treated with placebo (non-active agent). Both of drug was made in the same appearance of capsule (size and color). The participants have to start the drug when they have menstruation after that the dosage is 2 capsules for 3 times per day (after-meal) continue to 3 days. The participant have to record pain score (minimal/maximal/mean score) and multidimensional score in daily card, side effect and satisfaction. If the participant couldn't tolerate the pain, they could break the pain with mefenamic acid. They have record number of mefenamic acid which they used too. This study evaluate in only one cycle. After complete record, the participant come back to investigator for sending the report.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Woman who is diagnosed of primary dysmenorrhea.
- •Woman who has regular menstruation.
- •woman who has numeric rating score for pain during menstruation (dysmenorrhea) more than score 5 and continuous for 3 menstrual cycle.
- •Woman who want to participate in this study.
排除标准
- •Woman who has allergic history for herbal or other components in Ayurved Siriraj Prasaplai drug.
- •Woman who has hormonal contraception.
- •Woman who has other diseases which is caused of abdominal pain.
- •Breast feeding woman
研究组 & 干预措施
Ayurved Siriraj Prasaplai
干预措施: Ayurved Siriraj Prasaplai with or without mefenamic acid (Drug)
placebo
干预措施: Placebo with or without mefenamic acid (Drug)
结局指标
主要结局
Pain score between experimental and placebo group
时间窗: 1 year
Compare pain score by using numeric rating scale (NRS) between the group of women who recieve Ayurved Siriraj Prasaplai with placebo group.
次要结局
- To study about adverse effects of Ayurved Siriraj Prasaplai(1 year)
- Number of mefenamic acid for breaking pain during study of both group(1 year)