A Randomized, Double Blind, Placebo Controlled, Parallel Group, Comparative Clinical Study to Evaluate the Efficacy and Safety of OLNP-06 versus Placebo in Subjects with Primary Dysmenorrhea
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Mean Change from baseline in
研究概览
简要总结
Primary dysmenorrhea is oneof the most prevalent gynaecologic disorders, affecting more than half of allwomen of reproductive age. Symptoms of dysmenorrhea can be incapacitating andwomen experiencing severe symptoms of dysmenorrheal are unable to engage innormal activity and experience increased absence from school or work. Previousstudies have reported that the inhibition of COX-2 by nonspecific non-steroidalanti-inflammatory drugs (NSAIDs) decreases prostaglandin synthesis,contributing to their antipyretic and analgesic properties, and making themeffective for ameliorating the severity of menstrual pain in women. This study will evaluate the effect of standardised Ginger extract for the management of symptoms of Primary dysmenorrhea
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- Female
入选标准
- •Healthy Female subjects 18 – 35 years of age Regular menstrual cycle between
- •35 days with bleeding duration between three to seven days Suffering from primary dysmenorrhea Suffering from menstrual pain within the recent three consecutive months with a maximum VAS score of ≥4 Willing to sign the informed consent and comply with study procedure.
排除标准
- •Diagnosis of secondary dysmenorrhea due to pelvic pathology, such as uterine fibroids, adenomyosis, endometriosis, or pelvic inflammatory diseases Female who is lactating, currently pregnant, intention to become pregnant.
- •Current intrauterine device.
- •Patient taking regular NSAIDs for some therapeutic indication for pain relief other than menstrual pain.
- •Evidence or history of clinically significant (in the judgment of the Investigator) hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic diseases, or malignancies.
- •History of psychiatric disorder that may impair the ability of subjects to provide written informed consent Metrorrhagia with menstrual cycles less than 21 days or oligomenorrhea with cycles over 40 days.
- •Oral contraceptives or other hormonal treatment use within the past three months.
- •Subject who is having allergic to ginger.
结局指标
主要结局
Mean Change from baseline in
时间窗: Day 0, Week 4, week 8
Maximum Dysmenorrheic Pain VAS Score
时间窗: Day 0, Week 4, week 8
次要结局
- Mean Change from baseline to end of trial in(oVMS)