RecruitingPhase 3Phase 4ACTRN12614001053617

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.


Sponsor

Integrated Health Group Pty. Ltd.

Enrollment

150 participants

Start Date

Feb 9, 2015

Study Type

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

Sex: Both males and femalesMin Age: 16 YearssMax Age: 75 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing whether a saffron extract supplement called Affron can improve mood and mental sharpness in healthy adults who feel a bit down but have not been diagnosed with depression. Saffron is a spice that scientists believe may help with mood, memory, and sleep. Participants will take either Affron capsules or a look-alike sugar pill for 4 weeks, and researchers will check how their mood and thinking change. You may be eligible if: - You are between 16 and 75 years old - You sometimes feel low in mood but have NOT been diagnosed with depression - Your BMI is below 40 - You are willing to avoid foods cooked with saffron during the study You may NOT be eligible if: - You have been diagnosed with a mood disorder like depression or bipolar disorder - You take blood thinners such as warfarin - You take blood pressure medications - You have severe kidney or liver disease - You have a neurological disorder like multiple sclerosis - You work night shifts or suffer from insomnia - You are pregnant or currently in severe premenstrual pain Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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)

QLD, Australia

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ACTRN12614001053617


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