Condition category
Urological and Genital Diseases
Date applied
15/08/2008
Date assigned
21/08/2008
Last edited
21/08/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Baoru Yang

ORCID ID

Contact details

Aromtech Ltd
Tykistökatu 4 D (DIO)
Turku
20520
Finland

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

http://www.tyks.fi

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

Publication citations

Additional files

Editorial Notes