A randomized, double blind, placebo-controlled, crossover study to evaluate the effectiveness of topical application of Go-Go YIN oil blend on relieving the symptoms of Primary dysmenorrhea
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- 1.reduction of menstrual cramps and
研究概览
简要总结
The study will enrol adult female aged between 18-20 years that have been suffering from symptoms of primary dysmenorrhea. Eligible participants screened in baseline interview (assessment visit 1) will be randomized into two groups to be treated with either the test product Go-Go Yin essential oil or placebo. The baseline interview will collect data such as age, age at menarche, length of menstrual cycle, duration of menstrual flow, level and duration of pain, and amount of menstrual bleeding (number of saturated pads). Patients will be evaluated on first, second and third day of the menstrual cycle (assessment visit 2) after the first phase of treatment. Subsequently, for the second phase of treatment, the intervention will be switched between the groups and the subjects will be re-evaluated as before during the next menstrual period (assessment visit 3). Safety analyses will be done at each visit.
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 20.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Participants must be single females, aged 18-20 years old with regular cycles lasting three to seven days.
- •Subjects must have a negative pregnancy test.
- •Pregnant patients or individual with history of pregnancy will be excluded from the study.
- •2.Subjects suffering from primary dysmenorrhea with a pain level >5 (severe pain) on a visual analogue scale and are not undergoing treatment for the pain.
- •3.The menstrual discomfort experienced should not be due to secondary dysmenorrhea and the Subjects should not be suffering from any systemic or gynaecologic disorders.
- •4.Participants should be willing to sign a written consent for participation in the study and undergo a baseline interview.
- •5.Participants must be willing to commit to medication dosing and assessment visits for evaluation.
- •6.Participants must be willing to refrain from taking analgesics from the outset of the study until second phase evaluation (if patient force to take allopathic medicine, subject will be dropped from the study).
- •7.Participants must agree that during the study they will refrain from taking any new herbal supplement and prescription or non-prescription medications without prior approval of the research team.
- •8.Participants must agree to take healthy diet and life style.
排除标准
- •1.Participants with known or suspected secondary dysmenorrhea (major abdominal or pelvic surgery, endometriosis, pelvic inflammatory disease (PID), ovarian cysts, pathological vaginal secretion, chronic abdominal pain, inflammatory bowel disease, and irritable bowel syndrome).
- •2.Single or married subjects who are pregnant or have borne children.
- •3.Participants with a history of or current any kind of hormonal therapy during the last 6 months.
- •4.Participants with evidence or history of significant systemic or gynecological disorder.
- •(People with hypothyroidism who are on adequate and stable thyroid replacement will not be excluded).
- •5.Participants weighing less than 50 kg and malnourished.
- •6.Patients reporting use of analgesics during the study period.
- •7.Participant with known allergies to the main components of the test product or placebo.
- •8.Any participant who is not able to give adequate informed consent.
结局指标
主要结局
1.reduction of menstrual cramps and
时间窗: Baseline Visit (Assessment Visit 1) Day 4 menstrual cycle 1 | Assessment Visit 2Day 4, menstrual cycle 2 | Assessment Visit 3 Day 4, menstrual cycle 3
2.reduction in abdominal/pelvic pain within 30 minutes of the application of Go-Go Yin essential oil blend during the first three days of menstruation as compared to the placebo.
时间窗: Baseline Visit (Assessment Visit 1) Day 4 menstrual cycle 1 | Assessment Visit 2Day 4, menstrual cycle 2 | Assessment Visit 3 Day 4, menstrual cycle 3
3.Reduction in the duration of menstruation and/or
时间窗: Baseline Visit (Assessment Visit 1) Day 4 menstrual cycle 1 | Assessment Visit 2Day 4, menstrual cycle 2 | Assessment Visit 3 Day 4, menstrual cycle 3
4.Regulating excessive menstrual bleeding and improve pelvic health.
时间窗: Baseline Visit (Assessment Visit 1) Day 4 menstrual cycle 1 | Assessment Visit 2Day 4, menstrual cycle 2 | Assessment Visit 3 Day 4, menstrual cycle 3
次要结局
- Adverse Events(Baseline Visit (Assessment Visit 1) Day 4 menstrual cycle 1)