An open label pilot study to evaluate the effectiveness of a proprietary krill oil formulation in the relief of troublesome symptoms of the menopause

Not Applicable

Completed

• Conditions: Menopausal symptoms; Signs and Symptoms

• Registration Number: ISRCTN16288792
• Lead Sponsor: Total Health and Wellbeing Ltd

Brief Summary

2016 results in https://www.worldwidejournals.com/international-journal-of-scientific-research-(IJSR)/article/an-open-label-pilot-study-to-evaluate-the-effectiveness-of-a-proprietary-krill-oil-formulation-in-the-relief-of-troublesome-symptoms-of-the-menopause/ODY3NQ==/?is=1 (added 15/10/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2015-09-01
• Study Start: 2016-06-23
• Last Update Posted: 26 October 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

1. Women aged between 45 and 59 years old
2. Presenting with a subjective complaint of problematic menopausal symptoms for a minimum of three days per week for a period of at least 3 months
3. Presence of: marked impaired daytime functioning, hot flushes, appetite loss, sleepiness, nausea, dizziness, tiredness, dry mouth, abnormal sweating, constipation, trouble sleeping, nervousness, mood changes, vaginal changes, urinary incontinence

Exclusion Criteria

1. Evidence that menopausal symptoms are directly related to a severe or unstable medical disorder or severe psychiatric disorder (e.g.,bipolar disorder, schizophrenia)
2. Presence of sleep apnea or periodic limb movements during sleep
3. Presence of major depression or other severe psychopathology
4. Patients receiving HRT, clonidine, SSRI medications (antidepressants), Isoflavone containing supplements, Omega 3 or 6 supplements

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Symptom severity was assessed using a Menopause Rating Scale (MRS) which measures menopausal or climacteric symptoms in a standardized way and was validated some years ago. It aims to establish an instrument that measures health-related quality of life that can easily be completed. The original German scale has been translated into English and culturally adapted. Assessed at baseline, 1 month, 2 months and 3 months

Secondary Outcome Measures

Name	Time	Method
Side effects of the intervention assessed at baseline, 1 month, 2 months and 3 months