ACTRN12624000731594尚未招募Unknown
An examination into the safety and efficacy of Khaya senegalensis on pain, physical and emotional wellbeing in women experiencing menstrual distress: a randomised, double-blind, placebo-controlled trial
Bioactive Natural Health Pty Ltd0 个研究点目标入组 90 人开始时间: 2024年6月14日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 50 Years（—）
- 性别
- Female
入选标准
- •1. Menstruating females aged 18 to 50 years
- •2. Experience mild to moderately severe pain before and/or during menstruation, with a history of at least 3 months.
- •3. Experience physical and/or emotional symptoms associated with menstruation with a history of at least 3 months
- •4. Have a regular menstrual cycle length of 21 to 35 days
- •5. Non-smoker
- •6. BMI between 18 and 30 kg/m2
- •7. No plan to commence new treatments over the study period.
- •8. Understand, willing and able to comply with all study procedures.
- •9. Willing to provide a personally signed and dated informed consent form detailing all pertinent aspects of the trial.; 1. Menstruating females aged 18 to 50 years
- •2. Experience mild to moderately severe pain before and/or during menstruation, with a history of at least 3 months.
- •3. Experience physical and/or emotional symptoms associated with menstruation with a history of at least 3 months
- •4. Have a regular menstrual cycle length of 21 to 35 days
- •5. Non-smoker
- •6. BMI between 18 and 30 kg/m2
- •7. No plan to commence new treatments over the study period.
- •8. Understand, willing and able to comply with all study procedures.
- •9. Willing to provide a personally signed and dated informed consent form detailing all pertinent aspects of the trial.
排除标准
- •1. Suffering from recently diagnosed or unmanaged medical conditions including but not limited to: diabetes, hyper/hypotension, cardiovascular disease, gastrointestinal disease requiring regular use of medications, gallbladder disease/gallstones/biliary disease, autoimmune disease, cancer/malignancy, endocrine disease, or chronic/acute pain condition.
- •2. Diagnosis of a neurological or psychiatric conditions including but not limited to: psychiatric disorder (other than mild-to-moderate depression or anxiety), Parkinson’s disease, Alzheimer’s disease, intracranial haemorrhage, or head or brain injury.
- •3. Regular medication intake including but not limited to opioids, corticosterone, hormone-replacement therapy, gonadotrophin releasing hormone agonists.
- •4. Change in medication in the last 2 months or an expectation to change during the study duration.
- •5. Vitamins or herbal supplements that are reasonably expected to influence study measures.
- •6. In the last month, commenced or changed the dose of nutritional and/or herbal supplements that may impact on treatment outcomes.
- •7. Planned major lifestyle change in the next 2 months.
- •8. Alcohol intake greater than 14 standard drinks per week
- •9. Current or 12-month history of illicit drug abuse
- •10. Pregnant women, women who are breastfeeding, or women who intend to fall pregnant during the study period.
- •11. In the last year or in the next 3 months, any significant surgeries (except exploratory surgery for endometriosis and other menstrual conditions undertaken/occurring before or after the study period)
- •12. Participation in any other clinical trial in the last month; 1. Suffering from recently diagnosed or unmanaged medical conditions including but not limited to: diabetes, hyper/hypotension, cardiovascular disease, gastrointestinal disease requiring regular use of medications, gallbladder disease/gallstones/biliary disease, autoimmune disease, cancer/malignancy, endocrine disease, or chronic/acute pain condition.
- •2. Diagnosis of a neurological or psychiatric conditions including but not limited to: psychiatric disorder (other than mild-to-moderate depression or anxiety), Parkinson’s disease, Alzheimer’s disease, intracranial haemorrhage, or head or brain injury.
- •3. Regular medication intake including but not limited to opioids, corticosterone, hormone-replacement therapy, gonadotrophin releasing hormone agonists.
- •4. Change in medication in the last 2 months or an expectation to change during the study duration.
- •5. Vitamins or herbal supplements that are reasonably expected to influence study measures.
- •6. In the last month, commenced or changed the dose of nutritional and/or herbal supplements that may impact on treatment outcomes.
- •7. Planned major lifestyle change in the next 2 months.
- •8. Alcohol intake greater than 14 standard drinks per week
- •9. Current or 12-month history of illicit drug abuse
- •10. Pregnant women, women who are breastfeeding, or women who intend to fall pregnant during the study period.
- •11. In the last year or in the next 3 months, any significant surgeries (except exploratory surgery for endometriosis and other menstrual conditions undertaken/occurring before or after the study period)
- •12. Participation in any other clinical trial in the last month
研究者
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