NCT06227858

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 29, 2024

Completed
1.6 years until next milestone

Study Start

First participant enrolled

August 20, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2026

Completed
Last Updated

April 17, 2026

Status Verified

April 1, 2026

Enrollment Period

8 months

First QC Date

January 17, 2024

Last Update Submit

April 15, 2026

Conditions

Perimenopausal Disorder

Outcome Measures

Primary Outcomes (1)

  • Effect on overall perimenopause clinical symptoms severity

    Changes in Greene Climacteric Scale (GCS) score

    6-weeks, 12-weeks

Secondary Outcomes (8)

  • Effect on sleep quality

    6-weeks, 12-weeks

  • Effect on mood

    6-weeks, 12-weeks

  • Effect on quality of life

    6-weeks, 12-weeks

  • Exploratory measures

    12-weeks

  • Exploratory measures

    12-weeks

  • +3 more secondary outcomes

Study Arms (2)

Saffron extract supplementation (15mg, twice daily)

EXPERIMENTAL

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)

Control group

PLACEBO COMPARATOR

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

Interventions

Safr'Inside supplement (Activ'Inside, SAS)DIETARY_SUPPLEMENT

Dietary supplementation will be taken in addition to habitual diet of the patients

Saffron extract supplementation (15mg, twice daily)
PlceboOTHER

Placebo capsule (matched to the experimental intervention in terms of colours and taste, without the active compounds saffron)

Control group

Eligibility Criteria

Age40 Years - 55 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsBiologically characterised as Female
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Biochemistry, LUMHS

Jāmshoro, Sindh, 76060, Pakistan

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Randomisation will be processed by computer-generated random sequence number and will be performed by an independent member of the medical support team which will not be involved in the study
Purpose
SUPPORTIVE CARE
Intervention Model
FACTORIAL
Model Details: 2 x 2 factorial design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Clinical Biochemistry and Experimental medicine

Study Record Dates

First Submitted

January 17, 2024

First Posted

January 29, 2024

Study Start

August 20, 2025

Primary Completion

April 10, 2026

Study Completion

April 10, 2026

Last Updated

April 17, 2026

Record last verified: 2026-04

Locations

PA(1)