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临床试验/DRKS00006867
DRKS00006867暂停未知

Effect of a nutritional supplement with vitamins, magnesium and Rhodiola rosea extract on psychophysiological stress reactions in women during periods of stress

Rottapharm | Madaus GmbH - Madaus GmbH -0 个研究点目标入组 150 人开始时间: 2014年10月15日最近更新:
适应症

试验速览

阶段
未知
状态
暂停
入组人数
150

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 study
盲法
Blinded (masking used)

入排标准

年龄范围
20 Years 至 50 Years(—)
性别
Female

入选标准

  • Age: 20-50 years
  • healthy women
  • Written consent of the subjects after detailed oral and written explanation of the course content, requirements and risks
  • Ability and willingness of study participants to follow the instructions of the study leader (compliance with study conditions, taking the test product according to the dosage recommendation, etc.)

排除标准

  • severe chronic diseases (malignant tumors, diabetes mellitus type 1 and type 2, etc.), manifest cardiovascular disease (e.g. angina pectoris, heart failure), kidney failure, liver disease
  • Mental Disorders (ADHD, depression, panic attacks, anxiety, etc.)
  • diagnosed bleeding disorders as well as taking anticoagulant medications e.g. warfarin (except aspirin)
  • known allergy or intolerance to one of the ingredients contained in the test product
  • chronic gastrointestinal disorders (ulcerative colitis, Crohn's disease, pancreatic insufficiency)
  • heart surgery (stent, bypass, pacemaker) or digestive tract (exceptions: removal of appendix or gall bladder)
  • inflammation of the oral cavity associated with gingival bleeding (e.g. gingivitis, periodontitis, mucositis)
  • imminent surgery
  • ingestion of nutrient supplements, which contain Rhodiola rosea (Rhodiola)
  • taking anti-depressants, etc.
  • addiction to alcohol, drugs and / or medicines
  • Pregnancy and lactation
  • BMI > 30 kg / m2
  • incapacitated subjects
  • refusal or withdrawal of consent by the subject
  • Simultaneous participation in another clinical trial or to participate in the last 30 days

研究者

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