A Double-Blind, Randomized, placebo-controlled Study to Assess the Efficacy of Turmeric-Boswellia Formulation in Menstrual Cramp Pain Associated with Primary Dysmenorrhea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Total Pain Relief scores (TOTPAR 6) using pain relief categorical scale (0-4).
研究概览
简要总结
This is a randomized, double-blind, placebo-controlledstudy in adolescent and adult female participants with primary dysmenorrhea ofat least moderate pain. Qualified participants will be randomized into two groupsin 1:1 ratio to a single dose of test product or placebo (two soft gel of 500mg). The participant takes the assigned studymedication when menstrual cramp pain is ≥5 in severity using the 0-10 NumericalRating Scale (NRS) questionnaire. Before dosing, the participants will complete abaseline (immediately before dosing) 0-10 NRS menstrual cramp pain intensityevaluation. After taking the study medication, the participant will completethe pain/pain relief assessment (0-10 NRS and the 0-4 categorical pain reliefscale) at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5-, 5.5- and 6-hours post-dose (30minutes time intervals).At 6 hours post-dose, the participant will complete the Global Evaluation ofher overall satisfaction with the effectiveness of the study medication. If theparticipant decides to take rescue medication prior to the 6 hours, theparticipant will be instructed to complete the Global Evaluation prior totaking the rescue medication.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor 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 participants between 18 and 35 years of age.
- •Participant has a history of regular menstrual cycles that typically occurs between every 21 to 35 days.
- •Participant has a self-reported history of primary dysmenorrhea with at least moderate menstrual cramp pain (based on the categorical pain intensity scale 0-3).
- •Participant is willing to participate in the study and give voluntary informed consent.
排除标准
- •Participant has a known allergy to any of the ingredients in any of the study medication products;
- •Participant has significant co-existing illness, including gastrointestinal, hepatic, renal, neurologic, cardiovascular, psychiatric, endocrine, respiratory, surgical procedure or other condition that, in the Investigator’s judgment, contraindicates administration of the study medication;
- •Participant has a current or past history of one or more of the following conditions: secondary dysmenorrhea, pelvic inflammatory disease, urinary tract infection (currently acute or recurrent [defined as more than three per year]), adnexal masses, uterine fibroids, endometriosis, adenomyosis that in the opinion of the Investigator would impact participant safety and/or the study data;
- •Participant has an ongoing sexually transmitted disease (except for a history of genital herpes or Human Papillomavirus) or has abnormal vaginal discharge;
- •Participant requires prescription analgesics, narcotic, non-NSAID (i.e., defined as oral use of 5 or more times per week for greater than 3 weeks) or has routinely taken OTC medications in excess of label recommended instructions for control of dysmenorrhea symptoms;
- •Participant is taking mood-altering agents (e.g., antidepressants, sedatives, phenothiazines, or anti-anxiety agents).
- •Participant does not agree to abstain from taking any analgesic and/or anti- inflammatory approximately 72 hours prior to the anticipated treatment period and throughout the dosing/assessment period.
- •All pain and anti-inflammatory medications including supplements, topical heat or cold, and other products of topical application will be discontinued approximately 72 hours prior to the anticipated dosing for treatment period and throughout the dosing/assessment period;
- •Participant is pregnant, lactating, or less than 6 months postpartum;
- •Participant is currently using an oral contraceptive for less than 3 months, has been on an unstable dose within the last 3 months or has switched from one oral contraceptive to another within the last 3 months of the study;
- •Participant has a history of alcohol intake daily or drug abuse.
- •Participant with a medical disorder, condition or history such that could impair the participant’s ability to participate or complete this study in the opinion of the investigator.
结局指标
主要结局
Total Pain Relief scores (TOTPAR 6) using pain relief categorical scale (0-4).
时间窗: Each 30 min post-dose censored at 6 h
次要结局
- •Global Evaluation(At 6 hours post-dose or immediately before first intake of rescue medication)
- •Summed Pain Intensity Difference (SPID) over the 6-hour study period (SPID 0-6) using 0-10 NRS(•Pain Intensity Difference (PID) scores at each evaluation)