Search / Trial NCT06227858

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

Launched by LIAQUAT UNIVERSITY OF MEDICAL & HEALTH SCIENCES · Jan 25, 2024

Trial Information

Current as of October 09, 2024

Completed

Keywords

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 (...

Gender

FEMALE

Eligibility criteria

  • 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

About Liaquat University Of Medical & Health Sciences

Liaquat University of Medical & Health Sciences (LUMHS) is a leading institution dedicated to advancing healthcare through innovative research and clinical trials. With a commitment to improving patient outcomes, LUMHS integrates cutting-edge medical education, comprehensive healthcare services, and rigorous scientific inquiry. The university fosters a collaborative environment for researchers and healthcare professionals, aiming to translate scientific discoveries into practical applications. LUMHS is dedicated to upholding the highest ethical standards in clinical research, ensuring participant safety, and contributing to the global body of medical knowledge.

Locations

Jāmshoro, Sindh, Pakistan

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0