Effects of Sea Buckthorn Oil on Mucous Membranes (SBMM)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
The Finnish Funding Agency for Technology and Innovation
Information provided by (Responsible Party):
Petra Larmo, Aromtech Ltd.
ClinicalTrials.gov Identifier:
NCT01697085
First received: September 27, 2012
Last updated: April 23, 2013
Last verified: April 2013
  Purpose

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


Condition Intervention
Mucous Membranes
Dietary Supplement: Sea buckthorn oil
Dietary Supplement: Placebo oil

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effects of Sea Buckthorn Oil on Mucous Membranes

Resource links provided by NLM:


Further study details as provided by Aromtech Ltd.:

Primary Outcome 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) ] [ Designated as safety issue: No ]
    Interview for symptom score at baseline and study visits and a daily symptom logbook during the intervention


Secondary Outcome Measures:
  • Change from baseline in vaginal pH [ Time Frame: At baseline, at 3 months (end of intervention) ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    • 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


Estimated Enrollment: 115
Study Start Date: October 2012
Estimated Study Completion Date: May 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   55 Years to 75 Years
Genders 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Petra Larmo, R&D manager, Ph.D., Aromtech Ltd.
ClinicalTrials.gov Identifier: NCT01697085     History of Changes
Other Study ID Numbers: SBMM
Study First Received: September 27, 2012
Last Updated: April 23, 2013
Health Authority: Finland: Ethics Committee of the Hospital District of Southwest Finland

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

ClinicalTrials.gov processed this record on April 16, 2014