CompletedNot Applicable

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

Pakistan104 participantsStarted 2025-08-20

Plain-language 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.

Who can participate

Age range

40 Years – 55 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Effect on overall perimenopause clinical symptoms severity

Timeframe: 6-weeks, 12-weeks

Trial details

NCT IDNCT06227858

SponsorLiaquat University of Medical & Health Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-04-10

View on ClinicalTrials.gov More Perimenopausal Disorder trials