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
Scientific
Aromtech Ltd
Tykistökatu 4 D (DIO)
Turku
20520
Finland
Study information
| Study design | A randomised, double blind, placebo-controlled, single-centre parallel study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study acronym | SBMUCOS2008 |
| Study objectives | 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(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) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Sea buckthorn oil |
| Primary outcome measure | 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 study start date | 18/08/2008 |
| Completion date | 30/03/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 100 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 18/08/2008 |
| Date of final enrolment | 30/03/2009 |
Locations
Countries of recruitment
- Finland
Study participating centre
Aromtech Ltd
Turku
20520
Finland
20520
Finland
Sponsor information
Turku University Central Hospital (Finland)
Hospital/treatment centre
Hospital/treatment centre
c/o Risto Erkkola
Department of Gynecology
TYKS, PL 52
Turku
20521
Finland
| Website | http://www.tyks.fi |
|---|---|
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
