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Trial registered on ANZCTR


Registration number
ACTRN12614001053617
Ethics application status
Approved
Date submitted
24/09/2014
Date registered
2/10/2014
Date last updated
18/02/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
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.
Scientific title
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.
Secondary ID [1] 285398 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mood 293135 0
Stress 293136 0
cognitive function 293137 0
Sleep 293138 0
Condition category
Condition code
Alternative and Complementary Medicine 293404 293404 0 0
Herbal remedies
Mental Health 293441 293441 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 290310 0
Treatment: Other
Comparator / control treatment
2 maltodextrin tablets daily for 4 weeks
Control group
Placebo

Outcomes
Primary outcome [1] 293231 0
Mood - Assessed by the Profile of Mood States (POMS) questionnaire

Timepoint [1] 293231 0
Baseline, 2 weeks and 4 weeks
Primary outcome [2] 293232 0
Stress - Assessed by the Perceived Stress Scale
Timepoint [2] 293232 0
Baseline, 2 weeks and 4 weeks
Secondary outcome [1] 310647 0
Cognitive function - Assessed by Simple Reaction test and Memory Test
Timepoint [1] 310647 0
Baseline and week 4
Secondary outcome [2] 310648 0
Sleep Quality - Assessed by Pittsburgh Sleep Index
Timepoint [2] 310648 0
Baseline, week 2 and week 4

Eligibility
Key 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
Minimum age
16 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Potential participants will be preliminarily screened via on-line form and then by telephone, then requested to attend an information and question session where they will be informed of the trial process and asked to provide their consent prior to further involvement in the trial. Consenting participants will have a case history taken and undergo a brief medical assessment. The blinded product is supplied to the clinic staff and they allocate participants with a labelled trial product in numerical order (between 1 and 150) as they are enrolled.

Randomisation will be performed by the sponsor using Random Allocation Software, version 1.0, May 2004. Randomisation will be based on a total of 150 subjects, randomly allocated into either Active 1, Active 2 or Placebo arm of equal numbers of subjects (n=50 for each group).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation is performed by the sponsor using Random Allocation Software, version 1.0, May 2004. Randomisation is based on a total of 150 subjects, randomly allocated into either Active 1, Active 2 or Placebo arm of equal numbers of subjects (n=50 for each group).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 290004 0
Commercial sector/Industry
Name [1] 290004 0
Pharmactive Biotech Products, S.L.

Address [1] 290004 0
Parque Cientifico de Madrid – CLAID 3.14

Calle Faraday, 7

28049 Madrid
Country [1] 290004 0
Spain
Primary sponsor type
Commercial sector/Industry
Name
Integrated Health Group Pty. Ltd.
Address
Unit 3/59
Merthyr Road
New Farm Brisbane, Qld 4005
Country
Australia
Secondary sponsor category [1] 288687 0
None
Name [1] 288687 0
nil
Address [1] 288687 0
nil
Country [1] 288687 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291710 0
Queensland Clinical Trial Network
Ethics committee address [1] 291710 0
Level 3, 88 Jephson Street
Toowong QLD 4066
Ethics committee country [1] 291710 0
Australia
Date submitted for ethics approval [1] 291710 0
Approval date [1] 291710 0
10/09/2014
Ethics approval number [1] 291710 0
HREC2014002

Summary
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.
Trial website
www.integratedhealthgroup.com.au
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 51686 0
Dr Elizabeth Steels
Address 51686 0
Integrated Health Group Pty. Ltd.
Unit 3/59 Merthyr Rd
New Farm, Brisbane QLD 4005
Country 51686 0
Australia
Phone 51686 0
+61 7 31620909
Fax 51686 0
Email 51686 0
research@integratedhealthgroup.com.au
Contact person for public queries
Name 51687 0
Dr Elizabeth Steels
Address 51687 0
Integrated Health Group Pty. Ltd.
Unit 3/59 Merthyr Rd
New Farm, Brisbane QLD 4005
Country 51687 0
Australia
Phone 51687 0
+61 7 31620909
Fax 51687 0
Email 51687 0
research@integratedhealthgroup.com.au
Contact person for scientific queries
Name 51688 0
Dr Elizabeth Steels
Address 51688 0
Integrated Health Group Pty. Ltd.
Unit 3/59 Merthyr Rd
New Farm, Brisbane QLD 4005
Country 51688 0
Australia
Phone 51688 0
+61 7 31620909
Fax 51688 0
Email 51688 0
research@integratedhealthgroup.com.au

No information has been provided regarding IPD availability
Summary results
No Results