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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN16288792
Enrollment
100
Registered
2016-06-23
Start date
2015-02-01
Completion date
Unknown
Last updated
2020-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Menopausal symptoms Signs and Symptoms

Interventions

Each dose of the krill oil compound supplement contains thiamine hydrochloride 1.4mg, riboflavin 1.6mg, pyridoxine hydrochloride 2mg, standardised soy isoflavones 50mg-(S101), standardised rosemary ex

Sponsors

Total Health and Wellbeing Ltd
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Side effects of the intervention assessed at baseline, 1 month, 2 months and 3 months

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026