Saffron and its effects on sleep quality in adults with unsatisfactory sleep

Not Applicable

Completed

• Conditions: nsatisfactory sleep; Unsatisfactory sleep; Neurological - Other neurological disorders; Alternative and Complementary Medicine - Herbal remedies; Mental Health - Other mental health disorders

• Registration Number: ACTRN12620000973910
• Lead Sponsor: Clinical Research Australia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-09-28
• Study Completion: 2020-12-17
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. Healthy adults (male and female) between 18 and 70
2. Self-reported symptoms of poor sleep lasting longer than 4 weeks
3. Non-smoker
4. BMI between 20 and 35
5. Typical bedtime between 9 p.m. and 12 a.m.
6. Willing to provide a personally-signed and dated informed consent form detailing all pertinent aspects of the trial.

Exclusion Criteria

1. Employed in night shift work or rotational shift work
2. Suffer from a sleep disorder other than moderate insomnia (e.g, sleep apnoea, restless leg syndrome, periodic limb movement disorder)
3. Suffer from mental health disorder other than mild depressive or anxiety symptoms as measured by the Patient Health Questionnaire (PHQ-4)
4. Coffee intake greater than 3 cups a day (or equivalent caffeine intake from other caffeinated drinks e.g., tea, energy drinks)
5. Alcohol consumption > 14 standard drinks per week
6. Experiencing external factors that may affect sleep patterns (e.g., infant/children regularly wakening, excess noise, a snoring partner, pain condition)
7. Currently receiving non-pharmacological treatment of sleep disorders (e.g., cognitive behavioural therapy, relaxation therapy)
8. Current or 12-month history of illicit drug abuse
9. Pregnant women, women who are breastfeeding, or women who intended to fall pregnant.
10. Suffering from recently diagnosed or unmanaged medical conditions including but not limited to: diabetes, hyper/hypotension, cardiovascular disease, gastrointestinal disease requiring regular use of medications, gallbladder disease/gallstones/biliary disease, autoimmune disease, endocrine disease, acute or chronic pain condition
11. Diagnosis of medical or psychiatric conditions including but not limited to: psychiatric disorder (other than mild-to-moderate depression or anxiety), neurological disease (Parkinson’s, Alzheimer’s disease, intracranial haemorrhage, head or brain injury), and cancer/malignancy
12. Current use of pharmaceutical medications that may affect sleep quality
13. Current use of supplements that may affect sleep
14. Currently taking saffron supplements

Study & Design

• Study Type: Interventional
• Study Design: Not specified