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.

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614001053617

Enrollment

150

Registered

2014-10-02

Start date

2015-02-09

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

16 Years to 75 Years

Healthy volunteers

Yes

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 9.Since saffron may affect mood, people with any diagnosed mood disorders (major depressive disorder (MDD), bipolar disorders, substance-induced disorders) will be excluded. 10. Those suffering from insomnia or have night-shift employment and unable to have a normal night’s sleep 11. Women who are suffering severe premenstrual pain (reason being that their mood, pain etc may change during the study period). 12. People suffering any neurological disorders such as multiple sclerosis. 13. People that can not exclude foods containing saffron or the use of saffron in their cooking.

Outcome results