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Effects of Sea Buckthorn Oil on Mucous Membranes (SBMM)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
The Finnish Funding Agency for Technology and Innovation
Information provided by (Responsible Party):
Petra Larmo, Aromtech Ltd.
ClinicalTrials.gov Identifier:
NCT01697085
First received: September 27, 2012
Last updated: April 23, 2013
Last verified: April 2013
History of Changes
  Purpose

Aim of this study is to investigate the effects of intake of sea buckthorn oil on mucous membranes


Condition Intervention
Mucous Membranes
 Dietary Supplement: Sea buckthorn oil
Dietary Supplement: Placebo oil

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effects of Sea Buckthorn Oil on Mucous Membranes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Aromtech Ltd.:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    Interview for symptom score at baseline and study visits and a daily symptom logbook during the intervention


Secondary Outcome Measures:
  • Change from baseline in vaginal pH [ Time Frame: At baseline, at 3 months (end of intervention) ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    • 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


Estimated Enrollment: 115
Study Start Date: October 2012
Estimated Study Completion Date: May 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   55 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • use of estrogen replacement therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01697085

Locations
Finland
Turun Gynekologikeskus
Turku, Finland, 20100
Sponsors and Collaborators
Aromtech Ltd.
The Finnish Funding Agency for Technology and Innovation
Investigators
Principal Investigator: Risto Erkkola, Professor Turun Gynekologikeskus, Turku, Finland
  More Information

No publications provided

Responsible Party: Petra Larmo, R&D manager, Ph.D., Aromtech Ltd.
ClinicalTrials.gov Identifier: NCT01697085     History of Changes
Other Study ID Numbers: SBMM
Study First Received: September 27, 2012
Last Updated: April 23, 2013
Health Authority: Finland: Ethics Committee of the Hospital District of Southwest Finland

Keywords provided by Aromtech Ltd.:
sea buckthorn
mucous membrane
dryness
metabolic syndrome
vaginal atrophy

Additional relevant MeSH terms:
Adenocarcinoma
Adenocarcinoma, Mucinous
Mucositis
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
 Neoplasms, Cystic, Mucinous, and Serous
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on June 18, 2013