Effects of a Bacopa Monnieri extract (Bacognize) on sleep quality and stress parameters in healthy adults with poor sleep.

Not Applicable

Completed

• Conditions: nsatisfactory sleep; Stress; Unsatisfactory sleep; Neurological - Other neurological disorders; Metabolic and Endocrine - Normal metabolism and endocrine development and function; Alternative and Complementary Medicine - Herbal remedies

• Registration Number: ACTRN12620000770965
• Lead Sponsor: Clinical Research Australia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-07-27
• Study Completion: 2020-10-30
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1.Adults (male and female) between 18 and 70
2.Self-reported symptoms of poor sleep lasting greater than 4 weeks (participants will need to give a score of 3 or more on at least one of the first four questions on the BIS and a score of 3 or more on at least one of the last two questions)
3.Medication-free for at least 4 weeks apart from the contraceptive pill and no more than once a week use of pain-relieving medications.
4.Non-smoker
5.BMI between 20 and 30
6.Typical bedtime between 9 p.m. and 12 a.m.
7.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 sleep disorder other than moderate insomnia (e.g, sleep apnoea, restless leg syndrome, periodic limb movement disorder)
3.Chronic sleep disturbance greater than 1 year
4.Suffer from mental health disorder (other than mild depressive or anxiety symptoms as measured by the Depression, Anxiety and Stress Scale-21)
5.Coffee intake greater than 3 cups a day (or equivalent caffeine intake from other caffeinated drinks e.g., tea, energy drinks)
6.Alcohol consumption > 14 standard drinks per week
7.Experiencing external factors that may affect sleep patterns (e.g., infant/children regularly awakening, excess noise, snoring partner, pain condition)
8.Currently receiving non-pharmacological treatment of sleep disorders (e.g., cognitive behavioural therapy, relaxation therapy)
9.Current or 12-month history of illicit drug abuse
10.Pregnant women, women who are breastfeeding or women who intended to fall pregnant.
11.Suffering from medical conditions including but not limited to: diabetes, hyper/hypotension, cardiovascular disease, gastrointestinal disease requiring regular use of medications, gallbladder disease/gallstones/biliary disease, endocrine disease, psychiatric disorder, and neurological disease (Parkinson’s, Alzheimer’s disease, intracranial haemorrhage, head or brain injury), acute or chronic pain affecting sleep
12.Current use of supplements that may affect sleep
13.Currently taking Bacopa supplements

Study & Design

• Study Type: Interventional
• Study Design: Not specified