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Effects of Sea Buckthorn Oil on Mucous Membranes (SBMM)

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ClinicalTrials.gov Identifier: NCT01697085
Recruitment Status : Completed
First Posted : October 2, 2012
Last Update Posted : January 28, 2016
Sponsor:
Collaborator:
The Finnish Funding Agency for Technology and Innovation
Information provided by (Responsible Party):
Petra Larmo, Aromtech Ltd.

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

Condition or disease Intervention/treatment Phase
Mucous Membranes Dietary Supplement: Sea buckthorn oil Dietary Supplement: Placebo oil Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 116 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effects of Sea Buckthorn Oil on Mucous Membranes
Study Start Date : October 2012
Actual Primary Completion Date : April 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Sea buckthorn oil
3 g (6 capsules)/day for three months
Dietary Supplement: Sea buckthorn oil
Placebo Comparator: Placebo oil
3 g (6 capsules)/day for three months
Dietary Supplement: Placebo oil



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Change from baseline in vaginal pH [ Time Frame: At baseline, at 3 months (end of intervention) ]

Other Outcome Measures:
  1. Change from baseline in vaginal health index, vaginal dryness, vaginal maturity index, symptoms of dryness in other mucous membranes, markers of inflammation, oxidative stress and metabolic disorder in the circulation [ Time Frame: At baseline, at 3 months (end of intervention) ]
    • Vaginal health index: index score, change from baseline
    • Vaginal dryness: moistening of pH test strip, change from baseline
    • Vaginal maturity index: change from baseline
    • Symptoms of dryness in other mucous membranes: daily symptom logbook during the intervention
    • Markers of inflammation, oxidative stress and metabolic disorders: analysis from serum/plasma, change from baseline



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Ages Eligible for Study:   55 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • use of estrogen replacement therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01697085


Locations
Finland
Turun Gynekologikeskus
Turku, Finland, 20100
Sponsors and Collaborators
Aromtech Ltd.
The Finnish Funding Agency for Technology and Innovation
Investigators
Principal Investigator: Risto Erkkola, Professor Turun Gynekologikeskus, Turku, Finland

Study Data/Documents: Clinical Study Report  This link exits the ClinicalTrials.gov site

Responsible Party: Petra Larmo, R&D manager, Ph.D., Aromtech Ltd.
ClinicalTrials.gov Identifier: NCT01697085     History of Changes
Other Study ID Numbers: SBMM
First Posted: October 2, 2012    Key Record Dates
Last Update Posted: January 28, 2016
Last Verified: January 2016

Keywords provided by Petra Larmo, Aromtech Ltd.:
sea buckthorn
mucous membrane
dryness
metabolic syndrome
vaginal atrophy