NCT01697085CompletedNot Applicable
Effects of Sea Buckthorn Oil on Mucous Membranes
Aromtech Ltd.1 site in 1 country116 target enrollmentStarted: October 1, 2012Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 116
- Locations
- 1
- Primary Endpoint
- Change from baseline in dryness related symptoms of genital mucous membranes
Study Overview
Brief Summary
Aim of this study is to investigate the effects of intake of sea buckthorn oil on mucous membranes
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 55 Years to 75 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •women experiencing vaginal dryness
- •55-75 years of age
- •at least 12 months from menstruation
Exclusion Criteria
- •use of estrogen replacement therapy
Arms & Interventions
Sea buckthorn oil
Experimental
3 g (6 capsules)/day for three months
Intervention: Sea buckthorn oil (Dietary Supplement)
Placebo oil
Placebo Comparator
3 g (6 capsules)/day for three months
Intervention: Placebo oil (Dietary Supplement)
Outcomes
Primary Outcomes
Change from baseline in dryness related symptoms of genital mucous membranes
Time Frame: 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
Secondary Outcomes
- Change from baseline in vaginal pH(At baseline, at 3 months (end of intervention))
Investigators
Petra Larmo
R&D manager, Ph.D.
Aromtech Ltd.
Study Sites (1)
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