Effects of Sea Buckthorn Oil on Mucous Membranes (SBMM)
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ClinicalTrials.gov Identifier: NCT01697085 |
Recruitment Status :
Completed
First Posted : October 2, 2012
Last Update Posted : January 28, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Mucous Membranes | Dietary Supplement: Sea buckthorn oil Dietary Supplement: Placebo oil | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 116 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Basic Science |
Official Title: | Effects of Sea Buckthorn Oil on Mucous Membranes |
Study Start Date : | October 2012 |
Actual Primary Completion Date : | April 2013 |
Actual Study Completion Date : | May 2013 |
Arm | Intervention/treatment |
---|---|
Experimental: Sea buckthorn oil
3 g (6 capsules)/day for three months
|
Dietary Supplement: Sea buckthorn oil |
Placebo Comparator: Placebo oil
3 g (6 capsules)/day for three months
|
Dietary Supplement: Placebo oil |
- 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
- Change from baseline in vaginal pH [ Time Frame: At baseline, at 3 months (end of intervention) ]
- Change from baseline in vaginal health index, vaginal dryness, vaginal maturity index, symptoms of dryness in other mucous membranes, markers of inflammation, oxidative stress and metabolic disorder in the circulation [ Time Frame: At baseline, at 3 months (end of intervention) ]
- Vaginal health index: index score, change from baseline
- Vaginal dryness: moistening of pH test strip, change from baseline
- Vaginal maturity index: change from baseline
- Symptoms of dryness in other mucous membranes: daily symptom logbook during the intervention
- Markers of inflammation, oxidative stress and metabolic disorders: analysis from serum/plasma, change from baseline
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Ages Eligible for Study: | 55 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- women experiencing vaginal dryness
- 55-75 years of age
- at least 12 months from menstruation
Exclusion Criteria:
- use of estrogen replacement therapy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01697085
Finland | |
Turun Gynekologikeskus | |
Turku, Finland, 20100 |
Principal Investigator: | Risto Erkkola, Professor | Turun Gynekologikeskus, Turku, Finland |
Responsible Party: | Petra Larmo, R&D manager, Ph.D., Aromtech Ltd. |
ClinicalTrials.gov Identifier: | NCT01697085 |
Other Study ID Numbers: |
SBMM |
First Posted: | October 2, 2012 Key Record Dates |
Last Update Posted: | January 28, 2016 |
Last Verified: | January 2016 |
sea buckthorn mucous membrane dryness metabolic syndrome vaginal atrophy |