Effects of omega-7 sea buckthorn oil capsule on mucous membranes of post-menopausal women [omega 7-tyrniöljykapseleiden käyttö vaihdevuosioireiden, emättimen ja muiden limakalvojen kuivuuden ja virtsatieoireiden hoidossa]

ISRCTN ISRCTN91680999
DOI https://doi.org/10.1186/ISRCTN91680999
Secondary identifying numbers SBRE2008
Submission date
15/08/2008
Registration date
21/08/2008
Last edited
21/08/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Baoru Yang
Scientific

Aromtech Ltd
Tykistökatu 4 D (DIO)
Turku
20520
Finland

Study information

Study designA randomised, double blind, placebo-controlled, single-centre parallel study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study acronymSBMUCOS2008
Study objectivesIncreased 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(s)Ethics approval received from the Ethical Committee of the Hospital District of Southwest Finland on the 5th August 2008 (ref: 7/2008 § 254).
Health condition(s) or problem(s) studiedMucosa membrane dryness
InterventionGroup 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Sea buckthorn oil
Primary outcome measure1. 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 measures1. 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 study start date18/08/2008
Completion date30/03/2009

Eligibility

Participant type(s)Patient
Age groupSenior
SexBoth
Target number of participants100
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment18/08/2008
Date of final enrolment30/03/2009

Locations

Countries of recruitment

  • Finland

Study participating centre

Aromtech Ltd
Turku
20520
Finland

Sponsor information

Turku University Central Hospital (Finland)
Hospital/treatment centre

c/o Risto Erkkola
Department of Gynecology
TYKS, PL 52
Turku
20521
Finland

Website http://www.tyks.fi
ROR logo "ROR" https://ror.org/05dbzj528

Funders

Funder type

Government

Finnish Funding Agency for Technology and Innovation (TEKES) (Finland)

No information available

Aromtech Ltd (Finland)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan