Clinical trial NCT06227858: Effects of a Standardised Saffron Extract Supplementation on Symptoms Associated With Perimenopause in Healthy Women
Official title: Investigation of the Psychological and Physiological Effects of a Standardised Saffron Extract Supplementation on Symptoms Associated to Perimenopause in Healthy Older Women: A Randomised Double-blind, Placebo-Controlled, Parallel-group Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Perimenopausal Disorder
Lead sponsor: Liaquat University of Medical & Health Sciences
Sponsor class: OTHER
Collaborators: name: University of East Anglia
name: Activ'inside
First posted: 2024-01-29
Enrollment: 106
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 2 x 2 factorial design
Primary purpose: SUPPORTIVE_CARE

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).

Eligibility criteria: 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

Primary outcomes:
measure: Effect on overall perimenopause clinical symptoms severity
timeFrame: 6-weeks, 12-weeks
Secondary outcomes:
measure: Effect on sleep quality
timeFrame: 6-weeks, 12-weeks
measure: Effect on mood
timeFrame: 6-weeks, 12-weeks
measure: Effect on quality of life
timeFrame: 6-weeks, 12-weeks
measure: Exploratory measures
timeFrame: 12-weeks
measure: Exploratory measures
timeFrame: 12-weeks
measure: Exploratory measures
timeFrame: 12-weeks
measure: Exploratory measures
timeFrame: 12-weeks
measure: Exploratory measures
timeFrame: 12-weeks
Other outcomes:
Locations:
city: Jāmshoro
country: Pakistan
facility: Department of Biochemistry, LUMHS
state: Sindh
Study officials:
References: