KCT0003533招募中未知
A randomized placebo controlled, single-blind, multicenter, parallel designed clinical study to evaluate the efficacy and safety of PLC in perimenopausal or postmenopausal women with Hot Flashes
Dongguk University Ilsan Oriental Hospital0 个研究点目标入组 128 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 128
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 45(Year) 至 60(Year)（—）
- 性别
- Female
入选标准
- •0. Women aged between 45 and 60 years of age
- •1. Peri-menopausal or post-menopausal women with hot flush
- •1) Peri-menopausal women (who meet one of the following criteria)
- •? Have a history of amenorrhea for last 3~11 months from the consent day (visit 1)
- •? Have suffered irregular menstrual periods in the past 12 months from the consent day (visit 1)
- •2) Post-menopausal women (who meet one of the following criteria)
- •? Have a history of spontaneous amenorrhea for last 12 months
- •? 6 months of spontaneous amenorrhea with serum follicle-stimulating hormone levels greater than 40mIU/mL
- •? At least 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy
- •? After Hysterectomy
- •2. Women who had average daily hot flash score of 10 or higher for 1 week before the visit1 (hot flash score : daily frequency X severity [normal: 0, mild: 1, moderate: 2, severe: 3, very severe: 4]).
- •3. Those who agree to this clinical study after sufficient explanation.
排除标准
- •0. Women who are diagnosed with psychogenic menopausal symptoms.
- •1. a patient suspected of systemic diseases.
- •2. Having severe complications on heart, liver, kidney or other organs.
- •3. A medical history of malignant tumors
- •4. Having thyroid disease or abnormal thyroid function
- •5. Having Liver or Kidney dysfunction : in case that any values of sGOT, sGPT, bilirubin or serum creatinine exceeding over 2 times of normal level
- •6. Difficult to participate in this trial because of these diseases : Uncontrolled hypertension, diabetes with complications or under control with insulin injections and pumps, thyroid disease and those who are taking drugs due to them, acute hepatitis/hepatocirrhosis, severe hyperlipidemia, neuropathic disorders, severe cardiovascular disorders, tuberculosis and other infectious diseases.
- •7. A person who has a history of hypersensitivity to Hominis Placenta or other drugs and food, or an allergic disease that requires treatment.
- •8. Taking hormones/ hormone analogues except estrogen or progestin within past 1 month.
- •9. Having participated in another clinical trial within the past 3 months.
- •10. Not taking the washout period (acupuncture and moxibustion : over 1week, herbal medication and pharmacoacupuncture :over 3 week) after receiving therapy that may affect perimenopausal or postmenopausal symptoms such as Korean medicine treatment or other complementary medicine
- •11. Participants who were taking estrogen or estrogen/progestin before (except who had adequate washout periods
- •12. Participants who were taking antidepressants in the last 1 month
- •13. Patients with illness who are determined unsuitable for the acupuncture treatment.
- •14. Person with inflammation or scar on the treatment area.
- •15. A night-shift worker.
- •16. Does not have the ability to fill out study documents.
- •17. a person who researcher determined unsuitable for this trial
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