KCT0003967招募中未知
Effect of Dangguijakyaksan on lower limb blood circulation disturbance in climacteric and postmenopausal women: a randomized, double-blind, placebo-controlled pilot trial
Dunsan Korean Medicine Hospital of Daejeon University0 个研究点目标入组 46 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
- 46
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 65(Year)（—）
- 性别
- Female
入选标准
- •(1) 45-65 years
- •(2) menopausal or postmenopausal women
- •1) Menopausal women (women who meet one of the criteria below)
- •? Women who are not menopausal and whose amenorrhea has continued from 3 months to 11 months before the screening visit date (by self-report)
- •? Women who have had irregular menstruation for the past 12 months since the screening visit (if there was a change in menstrual cycle)
- •2) Postmenopausal women (women who meet one of the criteria below)
- •? Women who are naturally amenorrheic over the past 12 months
- •? Women who have natural amenorrhea for 6 months and whose serum FSH level is 40mIU / mL or more
- •? At least 6 weeks after bilateral ovariectomy (regardless of hysterectomy)
- •? Women who have undergone hysterectomy
- •(3) Those who complain of blood circulation disturbance of the lower limb (one of the subordinate symptoms or more)
- •? Legs or feet are cold.
- •? Legs are numb and seizd with cramp.
- •? Calves are swollen and heavy.
- •(4) A person who has received sufficient explanation of the clinical trial and agrees to participate and signs the study consent form
排除标准
- •(1) Those who received female hormone therapy within 6 months of screening visit
- •(2) Persons who have not passed the washout period determined by the investigator as the subjects to be tested who have received regular medical treatment that may affect menopausal and menopausal symptoms, or other treatment classified as similar medical treatment.(Acupuncture and moxibustion: more than 1 week, Chinese medicine, medicine and same main ingredient: more than 3 weeks, etc.)
- •(3) Those who have taken health functional foods or taken general medicines for the purpose of improving symptoms of menopausal symptoms within 4 weeks of screening visit
- •(4) HbA1c of 7% or more
- •(5) Those who are diagnosed with malignant tumors and undergoing chemotherapy
- •(6) persons with behavioral or depressive symptoms, anxiety neuropathy, and severe psychiatric disorders
- •(7) AST, ALT, ALP, and GGT are 1.5 times the normal upper limit
- •(8) BUN, creatinine 1.5 times the upper limit of normal
- •(9) Those with uncontrolled thyroid disease (those who are considered to be able to participate in this trial by the tester can participate)
- •(10) Others who are diagnosed with other diseases (peripheral neuropathy, spinal diseases, etc.) that may cause other hematological disorders
- •(11) who are currently receiving transfusion or erythropoietin treatment for severe anemia
- •(12) Postmenopausal Cause Unknown vaginal bleeding
- •(13) those with endometrial cancer or endometrial hyperplasia
- •(14) Those with lactose intolerance
- •(15) Participated in other clinical trials with treatment interventions within the past 3 months
- •(16) If the other clinical trial officer judges that it is inappropriate
研究者
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