Perimenopausal Disorder
Conditions
Brief summary
The aim of the present study is to assess the effects of a normalised saffron extract supplementation, which is an extract of the flower Crocus sativus, on perimenopausal symptoms.
Detailed description
After being informed about the study protocol aim and potential risks, healthy volunteer woman (walk-in outpatients) will undergo a pre-screening to determine eligibility for study entry. At the visit 1, patients who meet the pre-screening criteria will undergo a second screening to confirm their eligibility based on inclusion and exclusion criteria. After signing the inform consent form, patient who meet eligibility criteria will be randomised in a double-blind manner (participants and investigators) in a 1:1 ratio to saffron extract supplementation (15mg, twice daily) or matched placebo (twice daily) for a period of 3-months (12 weeks).
Interventions
DIETARY_SUPPLEMENTSafr'Inside supplement (Activ'Inside, SAS)
Dietary supplementation will be taken in addition to habitual diet of the patients
OTHERPlcebo
Placebo capsule (matched to the experimental intervention in terms of colours and taste, without the active compounds saffron)
Sponsors
Liaquat University of Medical & Health Sciences
University of East Anglia
Activ'inside
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Randomisation will be processed by computer-generated random sequence number and will be performed by an independent member of the medical support team which will not be involved in the study
Intervention model description
2 x 2 factorial design
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Biological Female which identify themselves as Women * Aged ≥ 40 years * Irregular menstrual cycle for at least 3 months * Presenting typical symptoms of perimenopause with GCS score over 20 * BMI range between 18-35 kg/m2 * Healthy woman
Exclusion criteria
* Less than 40 years old * Pregnant * Diagnosed with diseases related to reproductive system such as PCOS or endometriosis * Taking anti-depressant medication or sleeping pills * Taking hormonal replacement therapy (HRT) * Taking conventional drug treatment or dietary supplementation * Having medical history or medical/surgical event in the last 6 months, or has been treated for cancer or any other ongoing treatment for the past 3 months, * Current and/or past history of hyper/hypotension, CVD, diabetes, autoimmune diseases, musculoskeletal disorder or endocrine or immunocompromised or neurological or psychological disorders, * Being medicated for these conditions, * History of allergic reactions to saffron intake, * Decisionally challenged subjects or unable to comply to the study * Any conditions that could contraindicates the use of saffron * Currently smoking or ceased smoking in the past 3 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect on overall perimenopause clinical symptoms severity | 6-weeks, 12-weeks | Changes in Greene Climacteric Scale (GCS) score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect on sleep quality | 6-weeks, 12-weeks | Changes in Pittsburg sleep quality index (PSQI) score |
| Effect on mood | 6-weeks, 12-weeks | Changes in Profile of Mood State (POMS) score |
| Effect on quality of life | 6-weeks, 12-weeks | Changes in Short Form Health Survey (SF-36) score |
| Exploratory measures | 12-weeks | Changes in fasting plasma glucose level |
Countries
Pakistan
Outcome results
None listed