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

Perimenopausal Disorder Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06227858
Study type Interventional
Source Liaquat University of Medical & Health Sciences
Contact Dr. Amjad Khan, DPhil
Phone + 92 333 0506955
Email amjadkhan@lumhs.edu.pk
Status Recruiting
Phase N/A
Start date February 10, 2024
Completion date November 15, 2024
View Details
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