Mucous MembranesSBMMNCT01697085
Effects of Sea Buckthorn Oil on Mucous Membranes
A study testing Sea buckthorn oil in people with Mucous Membranes, run by Aromtech Ltd. at 1 site in Finland.
Trial summary
Aim of this study is to investigate the effects of intake of sea buckthorn oil on mucous membranes Read more about this study
- Who is it for?
- Ages 55 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mucous Membranes
- What is being tested?
- Sea buckthorn oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 116 participants
- Where
- 1 siteFinland
- Study dates
- Oct 2012to May 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- women experiencing vaginal dryness
- 55-75 years of age
- at least 12 months from menstruation
Who cannot join
- use of estrogen replacement therapy
Trial locations and contacts
1 site in 1 country.
About this study
Aim of this study is to investigate the effects of intake of sea buckthorn oil on mucous membranes
- Conditions
- Mucous Membranes
- Being tested
- Sea buckthorn oil, Placebo oil
- Keywords
- sea buckthorn, mucous membrane, dryness, metabolic syndrome, vaginal atrophy
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sea buckthorn oilDietary supplement
Placebo oilDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Sea buckthorn oil | Experimental | 3 g (6 capsules)/day for three months Receives: Dietary Supplement: Sea buckthorn oil |
| Placebo oil | Placebo comparator | 3 g (6 capsules)/day for three months Receives: Dietary Supplement: Placebo oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in dryness related symptoms of genital mucous membranes
Interview for symptom score at baseline and study visits and a daily symptom logbook during the intervention
Measured: Interviews at baseline, at 2 months, at 3 moths (end of intervention), and daily during the study (symptom logbooks)
Secondary outcomes (1)
Change from baseline in vaginal pH
Measured: At baseline, at 3 months (end of intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionApr 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mucous MembranesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aromtech Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Finnish Funding Agency for Technology and Innovation
- Responsible party
- Principal investigator, Petra Larmo, Aromtech Ltd.
- Investigators
- Risto Erkkola, Professor, Principal investigator, Turun Gynekologikeskus, Turku, Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01697085
- Sponsor's protocol ID
- SBMM
- Acronym
- SBMM
- Status last verified
- Jan 2016
- First submitted
- 27 Sep 2012
- Last updated
- 28 Jan 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Sea Buckthorn Oil on Mucous Membranes
- ClinicalTrials.gov ID
- NCT01697085
- Acronym / sponsor ID
- SBMM / SBMM
- Conditions
- Mucous Membranes
- Keywords
- sea buckthorn, mucous membrane, dryness, metabolic syndrome, vaginal atrophy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Aromtech Ltd.Industry (pharma, biotech, devices)
- Collaborators
- The Finnish Funding Agency for Technology and Innovation
- Study start
- Oct 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 2 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aim of this study is to investigate the effects of intake of sea buckthorn oil on mucous membranes
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sea buckthorn oil | Experimental | Dietary Supplement: Sea buckthorn oil3 g (6 capsules)/day for three months |
| Placebo oil | Placebo comparator | Dietary Supplement: Placebo oil3 g (6 capsules)/day for three months |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- women experiencing vaginal dryness
- 55-75 years of age
- at least 12 months from menstruation
Key exclusion criteria (1 listed)
- use of estrogen replacement therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sea buckthorn oil | Dietary supplement | Sea buckthorn oil |
| Placebo oil | Dietary supplement | Placebo oil |
Primary outcome
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
1 secondary outcome
Change from baseline in vaginal pH
Time frame: At baseline, at 3 months (end of intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Risto Erkkola, Professor principal investigator
Turun Gynekologikeskus, Turku, Finland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sea buckthorn oil in people with Mucous Membranes, run by Aromtech Ltd. at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2016.