A Double-Blind, Randomized, Placebo-controlled Study to Assess the Efficacy of Rhuleave-K in subjects with Primary Dysmenorrhea and its associated symptoms.
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 144
- 试验地点
- 4
- 主要终点
- 1. Menstrual Pain intensity using Visual Analogue Scale.
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled study in female participants with primary dysmenorrhea. Qualified participants based on inclusion and exclusion criteria will be randomized into four groups in 1:1:1:1 ratio. The participant takes the assigned study medication as per the study protocol. The proposed study aims to build on the evidence supporting Turmeric Boswellia formulation as a potential treatment for primary dysmenorrhea. By investigating different dosages and extended treatment durations, this study seeks to provide comprehensive data on the efficacy, safety, and optimal use of Turmeric Boswellia formulation, potentially offering a new and effective option for women suffering from this common and debilitating condition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •Healthy female subjects 18 years or older
- •Subject has a history of regular menstrual cycles that typically occurs between every 28 ± 5 days with minimum 3 days of menstrual flow.
- •History of at least 4 consecutive painful periods in the past 6 month
- •WaLIDD score (Working ability, location, intensity, days of pain, dysmenorrhea score) above 5
- •Average menstrual pain score of 50 mm or above on VAS pain scale.
- •Willing for non-pregnant status during entire study period
- •Willing to provide the informed consent form.
排除标准
- •Subject has a known allergy to any of the ingredients in any of the study medication products Subject 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
- •Subject has a current or 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 subject safety and/or the study data
- •Subject has an ongoing sexually transmitted disease (except for a history of genital herpes or Human Papillomavirus) or has abnormal vaginal discharge
- •Subject is taking mood-altering agents (e.g., antidepressants, sedatives, phenothiazines, or anti-anxiety agents).
- •Subject is pregnant, lactating, or less than 6 months postpartum
- •Subject 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
- •Subject has a history of alcohol intake daily or drug abuse.
- •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 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
- •Subject with a medical disorder, condition, or history such that could impair the subject’s ability to participate or complete this study in the opinion of the investigator.
结局指标
主要结局
1. Menstrual Pain intensity using Visual Analogue Scale.
时间窗: Baseline, Each menstrual periods with treatment till trial completion.
2. Duration of Menstrual pain (hours) using menstrual pain diary.
时间窗: Baseline, Each menstrual periods with treatment till trial completion.
3. Severity of dysmenorrhoea using WaLIDD score (Working ability, location, intensity, days of pain, dysmenorrhea score)
时间窗: Baseline, Each menstrual periods with treatment till trial completion.
次要结局
- Associated menstrual symptoms measured using symptoms severity scale.(Baseline, Each menstrual periods with treatment till trial completion.)
- Menstrual characteristics using the menstrual pain diary .(Baseline, Each menstrual periods with treatment till trial completion.)
- Treatment emergent Adverse events (TEAE) evaluation, and hypersensitivity.(Throughout the study duration)
研究者
Dr Binu T Kuruvilla
Arjuna Natural Private Limited