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

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.

Study Overview

• Status: Completed
• Conditions: Perimenopausal Disorder
• Intervention / Treatment: Dietary supplement: Safr'Inside supplement (Activ'Inside, SAS); Other: Plcebo

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 Type: Interventional
• Enrollment (Actual): 104
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Jāmshoro, Sindh, Pakistan, 76060
      • Department of Biochemistry, LUMHS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Dietary supplement: Safr'Inside supplement (Activ'Inside, SAS); Dietary supplementation will be taken in addition to habitual diet of the patients
Placebo Comparator: 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).	Other: Plcebo; Placebo capsule (matched to the experimental intervention in terms of colours and taste, without the active compounds saffron)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect on overall perimenopause clinical symptoms severity	Changes in Greene Climacteric Scale (GCS) score	6-weeks, 12-weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect on sleep quality	Changes in Pittsburg sleep quality index (PSQI) score	6-weeks, 12-weeks
Effect on mood	Changes in Profile of Mood State (POMS) score	6-weeks, 12-weeks
Effect on quality of life	Changes in Short Form Health Survey (SF-36) score	6-weeks, 12-weeks
Exploratory measures	Changes in fasting plasma glucose level	12-weeks
Exploratory measures	Changes in gut microbiome (16S RNA Seq)	12-weeks
Exploratory measures	Changes in FSH levels	12-weeks
Exploratory measures	Changes in LH levels	12-weeks
Exploratory measures	Changes in TSH levels	12-weeks

Collaborators and Investigators

• Sponsor: Liaquat University of Medical & Health Sciences
• Collaborators: University of East Anglia; Activ'inside

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2025
• Primary Completion (Actual): April 10, 2026
• Study Completion (Actual): April 10, 2026

Study Registration Dates

• First Submitted: January 17, 2024
• First Submitted That Met QC Criteria: January 25, 2024
• First Posted (Actual): January 29, 2024

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 15, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: LUMHS/REC/-221

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No