The effects of an Ocimum tenuiflorum (Holy Basil) extract on perceived stress, mood, sleep, and the stress response in healthy adults experiencing high stress

Not Applicable

Completed

• Conditions: High stress; Unsatisfactory sleep; Mental Health - Anxiety; Alternative and Complementary Medicine - Herbal remedies; Mental Health - Other mental health disorders

• Registration Number: ACTRN12621000609853
• Lead Sponsor: Clinical Research Australia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-21
• Study Completion: 2021-12-14
• Last Update Posted: 28 November 2022

Recruitment & Eligibility

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

Inclusion Criteria

1. Adults aged 18-65 years of age
2. Body mass index between 18.5 kg/m2 and 30 kg/m2
3. Currently experiencing high stress (as determined by a Perceived Stress Scale score of 14 or higher)
4. Stressor or anxiety has been present for greater than a month
5. Self-reported sleep difficulties (as determined by a rating of 3 or higher on at least one of the first 5 questions of the Insomnia Symptom Questionnaire)
6. Medication-free for at least 3 months. Use of analgesics (once a week) or contraceptive pill are permissible.
7. Non-smoker
8. No plan to commence new treatments over the study period
9. Willing to wear a Fitbit to bed for the duration of the study
10. Willing to provide a personally-signed informed consent form detailing all pertinent aspects of the trial.
11. Willing and able to take prescribed capsules for 8 weeks

Exclusion Criteria

1. Anticipated major stressor, change or medical procedure occurring during the study period likely to affect psychological or physical status
2. Participation in another clinical trial within 30 days before screening
3. Suffer from mental-health disorder other than mild depressive or anxiety symptoms as measured by Patient Health Questionnaire-4
4. Suffering from recently diagnosed or unmanaged medical conditions including but not limited to: diabetes, hyper/hypotension, cardiovascular disease, a gastrointestinal disease requiring regular use of medications, gallbladder disease/ gallstones/ biliary disease, autoimmune disease, endocrine disease, and acute or chronic pain condition
5. Alcohol consumption greater than 14 standard drinks per week
6. Current or 12-month history of illicit drug abuse
7. Caffeine intake greater than 4 cups a day
8. Pregnant women, women who are breastfeeding, or women who intended to fall pregnant.
9. Currently taking supplements that may impact on treatment outcome

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in stress levels as measured by the Perceived Stress Scale[Day 0, weeks 2, 4, 6, and 8 (primary endpoint) post-intervention commencement<br>]