A Double-Blind, Placebo-Controlled, Multi-Centered Phase III Clinical Study to Evaluate the Safety and Efficacy of Ginger Extract Granules in Subjects with Primary Dysmenorrhea.
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Reduction in dysmenorrhea pain as measured by a Visual Analogue Scale (VAS) and Working Ability, Location, Intensity, Days of Pain, Dysmenorrhea (WaLIDD) scale at menstrual cycle -2, -1, 1, 2, and 3 relative to dosing.
研究概览
简要总结
This study aims to evaluate the safety and efficacy of ginger extract granules compared to placebo in female subjects aged 20-30 years diagnosed with primary dysmenorrhea. It is a double-blind, placebo-controlled, multi-centered clinical trial involving 100 subjects. Participants will be randomized in a 1:1 ratio to receive either ginger extract granules or placebo twice daily for 90 days. The primary objective is to assess the impact on menstrual pain severity, with secondary objectives focusing on change in menstrual symptoms, improvement in female sexual function, quality of life and general wellness, monitoring of adverse events and abnormal laboratory data. The study also evaluates the changes in the Subject and Physician Global Assessment scale scores.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 30.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Healthy educated metro women aged greater than or equal to 20 and less than or equal to 30 years.
- •2.Married women with regular sexual life without childbirth or any abortion.
- •3.Having primary dysmenorrhea symptoms continuously for at least 2 menstrual cycles months prior to the study screening.
- •4.Non-allergic to test item.
- •5.Subjects having not more than one episode of severe dysmenorrhea in a given menstrual cycle.
- •6.Subjects with self-reported history of primary dysmenorrhea with moderate (VAS Score greater than or equal to 4 to less than or equal to 6) menstrual cramp pain (based on the 10-point Visual Analogue Scale) occurring during four of the past six menstrual cycles.
- •7.Desirability and comfortability to use menstrual cups throughout the study.
- •8.Subjects willing to participate in the study.
- •9.Subjects who are willing to sign the informed consent and participate in the study.
- •10.Subjects willing to use only condoms as contraceptive method.
排除标准
- •1.Devoid of secondary dysmenorrhea and other fertility-related issues.
- •2.Subject has a current or past history of severe gastritis, gastrointestinal bleeding or ulceration.
- •3.Subject has a current or past history of the urinary tract infection.
- •4.Positive pregnancy test or breastfeeding at screening and prior to dosing.
- •5.Subjects with previous history of abortion.
- •6.Subjects with aversion to sexual life or sexual partner.
- •7.Subjects with hypoactive sexual desire disorder.
- •8.Subjects with spouse living in different area/ city.
- •9.Subjects who are single house wives.
结局指标
主要结局
Reduction in dysmenorrhea pain as measured by a Visual Analogue Scale (VAS) and Working Ability, Location, Intensity, Days of Pain, Dysmenorrhea (WaLIDD) scale at menstrual cycle -2, -1, 1, 2, and 3 relative to dosing.
时间窗: 1. Baseline (Pre-treatment) | 2. 4 weeks after the start of dosing (approximately Day 1 of the 2nd menstrual cycle) | 3. 8 weeks after the start of dosing (approximately Day 1 of the 3rd menstrual cycle) | 4. 12 weeks after the start of dosing (approximately Day 1 of the 4th menstrual cycle)
Also, number of subjects with reduction in the dysmenorrhea pain will be documented.
时间窗: 1. Baseline (Pre-treatment) | 2. 4 weeks after the start of dosing (approximately Day 1 of the 2nd menstrual cycle) | 3. 8 weeks after the start of dosing (approximately Day 1 of the 3rd menstrual cycle) | 4. 12 weeks after the start of dosing (approximately Day 1 of the 4th menstrual cycle)
次要结局
- 1.Change in physical, mood, & behavioral symptoms.(2.Improvement in female sexual function.)