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临床试验/NCT01697085
NCT01697085已完成不适用

Effects of Sea Buckthorn Oil on Mucous Membranes

Aromtech Ltd.1 个研究点 分布在 1 个国家目标入组 116 人开始时间: 2012年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
116
试验地点
1
主要终点
Change from baseline in dryness related symptoms of genital mucous membranes

研究概览

简要总结

Aim of this study is to investigate the effects of intake of sea buckthorn oil on mucous membranes

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
55 Years 至 75 Years(Adult, Older Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •women experiencing vaginal dryness
  • •55-75 years of age
  • •at least 12 months from menstruation

排除标准

  • •use of estrogen replacement therapy

研究组 & 干预措施

Sea buckthorn oil

Experimental

3 g (6 capsules)/day for three months

干预措施: Sea buckthorn oil (Dietary Supplement)

Placebo oil

Placebo Comparator

3 g (6 capsules)/day for three months

干预措施: Placebo oil (Dietary Supplement)

结局指标

主要结局

Change from baseline in dryness related symptoms of genital mucous membranes

时间窗: Interviews at baseline, at 2 months, at 3 moths (end of intervention), and daily during the study (symptom logbooks)

Interview for symptom score at baseline and study visits and a daily symptom logbook during the intervention

次要结局

  • Change from baseline in vaginal pH(At baseline, at 3 months (end of intervention))

研究者

发起方
Aromtech Ltd.
申办方类型
Industry
责任方
Principal Investigator
主要研究者

Petra Larmo

R&D manager, Ph.D.

Aromtech Ltd.

研究点 (1)

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