Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
SBRE2008
Study information
Scientific title
Acronym
SBMUCOS2008
Study hypothesis
Increased oxidative stress to the secretion glands and the cells of mucous membranes is part of the mechanism of ageing-related dryness and inflammation in the mucous membranes of female subjects. Sea buckthorn oil supports the health of mucous membranes by supplying the body with lipid nutrients required for maintaining the structure and function and for regeneration of mucous membranes. High content of antioxidants in sea buckthorn oil will increase the antioxidant capacity and reduce lipid peroxidation of plasma. Supplementation with sea buckthorn oil will decrease the plasma C-reactive protein (CRP) level indicating reduced inflammation in the body.
Ethics approval
Ethics approval received from the Ethical Committee of the Hospital District of Southwest Finland on the 5th August 2008 (ref: 7/2008 § 254).
Study design
A randomised, double blind, placebo-controlled, single-centre parallel study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Mucosa membrane dryness
Intervention
Group one: omega 7 capsules 2 x 2 capsules per day for 4 months
Group two: placebo capsules (medium chain triglycerides), 2 x 2 capsules per day for 4 months
Intervention type
Drug
Phase
Not Specified
Drug names
Sea buckthorn oil
Primary outcome measures
1. Dryness, itching, pain, burning and/or inflammation in the mucosa of the genital tract at baseline, after one and four months of supplementation
2. Vaginal PH at baseline, after one and four months of supplementation
3. Maturation index of vaginal mucosa at baseline, after one and four months of supplementation
Secondary outcome measures
1. Plasma total anoxidative capacity at baseline, after one and four months of supplementation
2. Plasma isoprostane level at baseline, after one and four months of supplementation
3. Plasma C-reactive protein level at baseline, after one and four months of supplementation
Overall trial start date
18/08/2008
Overall trial end date
30/03/2009
Reason abandoned
Eligibility
Participant inclusion criteria
1. Healthy post-menopausal females aged 55 - 70 years
2. Dryness, itching, pain, burning and/or inflammation in the mucosa of the genital tract
3. Problem of the genital tract mucosa shall not have clear association with severe diseases
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
100
Participant exclusion criteria
1. Severe diseases and/or receiving systematic medications such as hormone replacement therapy, anti-inflammatory and cholesterol lowering drugs
2. Diabetes
3. Hormonal, renal, haematological, or hepatic dysfunction
Recruitment start date
18/08/2008
Recruitment end date
30/03/2009
Locations
Countries of recruitment
Finland
Trial participating centre
Aromtech Ltd
Turku
20520
Finland
Sponsor information
Organisation
Turku University Central Hospital (Finland)
Sponsor details
c/o Risto Erkkola
Department of Gynecology
TYKS
PL 52
Turku
20521
Finland
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
Finnish Funding Agency for Technology and Innovation (TEKES) (Finland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Aromtech Ltd (Finland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary