Effects of Sea Buckthorn Oil on Mucous Membranes (SBMM)

January 27, 2016 updated by: Petra Larmo, Aromtech Ltd.
Aim of this study is to investigate the effects of intake of sea buckthorn oil on mucous membranes

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

116

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Turku, Finland, 20100
        • Turun Gynekologikeskus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

51 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • use of estrogen replacement therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Interviews at baseline, at 2 months, at 3 moths (end of intervention), and daily during the study (symptom logbooks)

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At baseline, at 3 months (end of intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aromtech Ltd.

Collaborators

The Finnish Funding Agency for Technology and Innovation

Investigators

  • Principal Investigator: Risto Erkkola, Professor, Turun Gynekologikeskus, Turku, Finland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

September 27, 2012

First Submitted That Met QC Criteria

September 28, 2012

First Posted (Estimate)

October 2, 2012

Study Record Updates

Last Update Posted (Estimate)

January 28, 2016

Last Update Submitted That Met QC Criteria

January 27, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SBMM

Plan for Individual participant data (IPD)

Study Data/Documents

  1. Clinical Study Report

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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