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.
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.
150 participants
Feb 9, 2015
Interventional
Conditions
Summary
Preliminary scientific evidence suggests that Saffron (Crocus sativus) may have beneficial effects on the central nervous system (CNS), and have therapeutic applications for mood, anxiety, depression, insomnia, memory and as an anticonvulsant. The aim of this study is to conduct a preliminary study of a Affron, a standardised extract of Crocus sativus (Saffron) for potential efficacy for mood and cognitive function in healthy adults.
Eligibility
Inclusion Criteria5
- 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
- Otherwise healthy; including BMI <40.
- Written informed consent from the subject
Exclusion Criteria14
- Subjects will be excluded for any one of the following reasons:
- Any condition which in the opinion of the investigator makes the subject unsuitable for inclusion
- Known hypersensitivity to herbal drugs/nutritional supplement/ foods
- Receiving/ prescribed coumadin (Warfarin), heparin, daltaparin, enoxaparin or other anticoagulation therapy
- Diagnosed with hypertension and receiving/ prescribed antihypertensive medications
- Diagnosed severe renal and/or hepatic insufficiency
- Current or history of chronic alcohol and/or drug abuse
- Participation in any other clinical trial during last 30 days
- Simultaneous participation in another clinical trial
- Since saffron may affect mood, people with any diagnosed mood disorders (major depressive disorder (MDD), bipolar disorders, substance-induced disorders) will be excluded.
- Those suffering from insomnia or have night-shift employment and unable to have a normal night’s sleep
- Women who are suffering severe premenstrual pain (reason being that their mood, pain etc may change during the study period).
- People suffering any neurological disorders such as multiple sclerosis.
- People that can not exclude foods containing saffron or the use of saffron in their cooking.
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Interventions
The investigational product is a tablet-form herbal formulation containing Affron, a standardised extract of Saffron (Crocus sativus) extract. The daily dose will be 2 tablets per day for a total of 22mg or 28mg per day for 4 weeks.
Locations(1)
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ACTRN12614001053617