Effects of a Standardised Saffron Extract Supplementation on Symptoms Associated With Perimenopause in Healthy Women
NCT ID: NCT06227858
Last Updated: 2025-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
104 participants
INTERVENTIONAL
2025-08-20
2026-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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Saffron extract supplementation (15mg, twice daily)
The experimental group will take a single capsule containing: 15mg of of saffron extract (stigma of the flower Crocus sativus), 340mg of Maltodextrin, encapsulated in hydroxypropyl methyl cellulose (HPMC), twice daily (one morning and one evening after the meal).
Safr'Inside supplement (Activ'Inside, SAS)
Dietary supplementation will be taken in addition to habitual diet of the patients
Control group
The Control group will take a single placebo capsule (matched to the experimental intervention in terms of colours and taste, without the active compounds saffron) twice daily (one morning and one evening after the meal).
Plcebo
Placebo capsule (matched to the experimental intervention in terms of colours and taste, without the active compounds saffron)
Interventions
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Safr'Inside supplement (Activ'Inside, SAS)
Dietary supplementation will be taken in addition to habitual diet of the patients
Plcebo
Placebo capsule (matched to the experimental intervention in terms of colours and taste, without the active compounds saffron)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
40 Years
55 Years
FEMALE
Yes
Sponsors
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University of East Anglia
OTHER
Activ'inside
INDUSTRY
Liaquat University of Medical & Health Sciences
OTHER
Responsible Party
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Dr. Amjad Khan
Professor of Clinical Biochemistry and Experimental medicine
Locations
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Department of Biochemistry, LUMHS
Jāmshoro, Sindh, Pakistan
Countries
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Central Contacts
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Facility Contacts
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Dr. Amjad Khan, DPhil
Role: primary
Other Identifiers
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LUMHS/REC/-221
Identifier Type: -
Identifier Source: org_study_id