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

Not Applicable

Active, not recruiting

• Conditions: Perimenopausal Disorder
• Interventions: Dietary Supplement: Safr'Inside supplement (Activ'Inside, SAS); Other: Plcebo

• Registration Number: NCT06227858
• Lead Sponsor: Liaquat University of Medical & Health Sciences

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).

Study Timeline

• Study First Submitted: 2024-01-17
• Study First Submitted QC: 2024-01-25
• Study First Posted: 2024-01-29
• Study Start: 2024-02-10
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-06
• Last Update Posted: 2025-05-09
• Primary Completion: 2025-10-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 106

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Saffron extract supplementation (15mg, twice daily)	Safr'Inside supplement (Activ'Inside, SAS)	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).
Control group	Plcebo	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).

Primary Outcome Measures

Name	Time	Method
Effect on overall perimenopause clinical symptoms severity	6-weeks, 12-weeks	Changes in Greene Climacteric Scale (GCS) score

Secondary Outcome Measures

Name	Time	Method
Effect on mood	6-weeks, 12-weeks	Changes in Profile of Mood State (POMS) score
Exploratory measures	12-weeks	Changes in TSH levels
Effect on sleep quality	6-weeks, 12-weeks	Changes in Pittsburg sleep quality index (PSQI) score
Effect on quality of life	6-weeks, 12-weeks	Changes in Short Form Health Survey (SF-36) score

Trial Locations

Locations (1)

Department of Biochemistry, LUMHS; 🇵🇰 Jāmshoro, Sindh, Pakistan