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Effects of Sea Buckthorn Oil on Mucous Membranes (SBMM)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01697085
First Posted: October 2, 2012
Last Update Posted: January 28, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
The Finnish Funding Agency for Technology and Innovation
Information provided by (Responsible Party):
Petra Larmo, Aromtech Ltd.
September 27, 2012
October 2, 2012
January 28, 2016
October 2012
April 2013   (Final data collection date for 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) ]
Interview for symptom score at baseline and study visits and a daily symptom logbook during the intervention
Same as current
Complete list of historical versions of study NCT01697085 on ClinicalTrials.gov Archive Site
Change from baseline in vaginal pH [ Time Frame: At baseline, at 3 months (end of intervention) ]
Same as current
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
Same as current
 
Effects of Sea Buckthorn Oil on Mucous Membranes
Effects of Sea Buckthorn Oil on Mucous Membranes
Aim of this study is to investigate the effects of intake of sea buckthorn oil on mucous membranes
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Mucous Membranes
  • Dietary Supplement: Sea buckthorn oil
  • Dietary Supplement: Placebo oil
  • Experimental: Sea buckthorn oil
    3 g (6 capsules)/day for three months
    Intervention: Dietary Supplement: Sea buckthorn oil
  • Placebo Comparator: Placebo oil
    3 g (6 capsules)/day for three months
    Intervention: Dietary Supplement: Placebo oil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
116
May 2013
April 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • women experiencing vaginal dryness
  • 55-75 years of age
  • at least 12 months from menstruation

Exclusion Criteria:

  • use of estrogen replacement therapy
Sexes Eligible for Study: Female
55 Years to 75 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Finland
 
 
NCT01697085
SBMM
Not Provided
Not Provided
Not Provided
Petra Larmo, Aromtech Ltd.
Aromtech Ltd.
The Finnish Funding Agency for Technology and Innovation
Principal Investigator: Risto Erkkola, Professor Turun Gynekologikeskus, Turku, Finland
Aromtech Ltd.
January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP