NCT06227858

Effects of a Standardised Saffron Extract Supplementation on Symptoms Associated With Perimenopause in Healthy Women

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 104 (actual)
• Sponsor: Liaquat University of Medical & Health Sciences · Academic / Other
• Sex: Female
• Age: 40 Years – 55 Years
• Healthy volunteers: Accepted

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).

Conditions

• Perimenopausal Disorder

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Safr'Inside supplement (Activ'Inside, SAS)	Dietary supplementation will be taken in addition to habitual diet of the patients
OTHER	Plcebo	Placebo capsule (matched to the experimental intervention in terms of colours and taste, without the active compounds saffron)

Timeline

• Start date: 2025-08-20
• Primary completion: 2026-04-10
• Completion: 2026-04-10
• First posted: 2024-01-29
• Last updated: 2026-04-17

Locations

1 site across 1 country: Pakistan