Effects of Sea Buckthorn Oil on Mucous Membranes

Mucous Membranes Clinical Trial

— SBMM  

Official title:

Effects of Sea Buckthorn Oil on Mucous Membranes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01697085
• Other study ID #: SBMM
• Status: Completed
• Phase: N/A
• First received: September 27, 2012
• Last updated: January 27, 2016
• Start date: October 2012
• Est. completion date: May 2013

Study information

• Verified date: January 2016
• Source: Aromtech Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee of the Hospital District of Southwest Finland
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: May 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 55 Years to 75 Years

Eligibility

Inclusion Criteria:

• women experiencing vaginal dryness

• 55-75 years of age

• at least 12 months from menstruation

Exclusion Criteria:

• use of estrogen replacement therapy

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Mucous Membranes

Intervention

Dietary Supplement:
• Sea buckthorn oil

• Placebo oil

Locations

Country	Name	City	State
Finland	Turun Gynekologikeskus	Turku

Sponsors (2)

Lead Sponsor	Collaborator
Aromtech Ltd.	The Finnish Funding Agency for Technology and Innovation

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	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	At baseline, at 3 months (end of intervention)	No
Primary	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	Interviews at baseline, at 2 months, at 3 moths (end of intervention), and daily during the study (symptom logbooks)	No
Secondary	Change from baseline in vaginal pH		At baseline, at 3 months (end of intervention)	No