ACTRN12614001053617
Recruiting
Phase 3
A randomized clinical trial to determine the efficacy of Affron, a standardised extract of Saffron (Crocus sativus) on mood and cognitive function in healthy adults over 4 weeks.
Integrated Health Group Pty. Ltd.0 sites150 target enrollmentOctober 2, 2014
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Mood
- Sponsor
- Integrated Health Group Pty. Ltd.
- Enrollment
- 150
- Status
- Recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Adult males and females reporting having a low mood but:
- •a) not diagnosed with a mood disorder such as depression, and
- •b) assessed as not suffering from depression by the Beck Depression QOL at screening
- •2\. Otherwise healthy; including BMI \<40\.
- •3\. Written informed consent from the subject
Exclusion Criteria
- •Exclusion Criteria
- •Subjects will be excluded for any one of the following reasons:
- •1\. Any condition which in the opinion of the investigator makes the subject unsuitable for inclusion
- •2\. Known hypersensitivity to herbal drugs/nutritional supplement/ foods
- •3\. Receiving/ prescribed coumadin (Warfarin), heparin, daltaparin, enoxaparin or other anticoagulation therapy
- •4\. Diagnosed with hypertension and receiving/ prescribed antihypertensive medications
- •5\. Diagnosed severe renal and/or hepatic insufficiency
- •6\. Current or history of chronic alcohol and/or drug abuse
- •7\. Participation in any other clinical trial during last 30 days
- •8\. Simultaneous participation in another clinical trial
Outcomes
Primary Outcomes
Not specified
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