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Clinical Trials/ACTRN12614001053617
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.

Registry
who.int
Start Date
October 2, 2014
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Integrated Health Group Pty. Ltd.

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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