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临床试验/RPCEC00000184
RPCEC00000184尚未招募4 期

Effects of D-003 (10 mg / day) and omega-3 fatty acids on the quality of life in postmenopausal women at risk for osteoporosis - D-003/Omega

atural Products Center/ National Center for Scientific Researchs0 个研究点目标入组 50 人开始时间: 2014年8月15日最近更新:
适应症

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
50

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
Randomized controlled trial. Masking: Double Blind. Control group: Active. Assignment: Parallel. Purpose: Treatment

入排标准

年龄范围
20 years 至 80 years(—)
性别
Female

入选标准

  • 1. Healthy female volunteers from common people.
  • 2. Aged between 20 and 80 years old.
  • 3. Surgically or naturally postmenopausal (defined as amenorrhea maintained for a period = 1 year).
  • 4. Risk of osteoporosis moderate to high according to the scale of risk
  • 5. Which have consented to give their informed consent.

排除标准

  • 1. Active liver disease, Active kidney disease, diagnosed Neoplasms or thyroid dysfunction.
  • 2. Severe high blood pressure (90 mm Hg)
  • 3. Uncompensated diabetes mellitus (fasting glucose> 7 mmol / L)
  • 4.Consumption of hormone replacement therapy, bisphosphonates, anabolic steroids, calcitonin, sodium fluoride or corticosteroids in the 6 months prior to inclusion
  • 5. The following values ??in laboratory tests: fasting glucose> 7 mmol / L; creatinine> 130 mol / L; alanine aminotransferase (ALT) or aspartate aminotransferase (AST)> 55 IU / L
  • 6. History of acute myocardial infarction (AMI), surgical revascularization or cerebrovascular accident (CVA) (stroke) in the 6 months prior to inclusion.
  • 7. Subjects with normal clinical history of drug allergy or any other special condition that endanger their health and their lives during the study.

研究者

发起方
atural Products Center/ National Center for Scientific Researchs

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