Effects of Sea Buckthorn Oil on Mucous Membranes

Overview

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

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Basic Science
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Study Primary Completion Date: April 2013

Interventions

• Dietary Supplement: Sea buckthorn oil
• Dietary Supplement: Placebo oil

Arms, Groups and Cohorts

• Experimental: Sea buckthorn oil
  • 3 g (6 capsules)/day for three months
• Placebo Comparator: Placebo oil
  • 3 g (6 capsules)/day for three months

Clinical Trial Outcome Measures

Primary Measures

• 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 Measures

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

Participating in This Clinical Trial

Inclusion Criteria

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

• use of estrogen replacement therapy

Gender Eligibility: Female

Minimum Age: 55 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

• Lead Sponsor
  • Aromtech Ltd.
• Collaborator
  • The Finnish Funding Agency for Technology and Innovation
• Provider of Information About this Clinical Study
  • Principal Investigator: Petra Larmo, R&D manager, Ph.D. – Aromtech Ltd.
• Overall Official(s)
  • Risto Erkkola, Professor, Principal Investigator, Turun Gynekologikeskus, Turku, Finland