FELIX Advanced

The Current State of Mental and Emotional
Health in Society
More people suffer from depression today than ever before. Reports from the Centers for Disease Control
reveal that 1 in 10 US adults believe they are suffering from depression. In a press release for World Health
Day on 7 April 2017, the WHO stated that depression is the leading cause of ill health and disability.
Over the last 25 years, the use of antidepressant medication in the US has gone up 400%, and 11% of
Americans aged 12 years and over now take antidepressant medication.
Approximately 90% of patients on antidepressant medication experience at least one of the numerous
serious side effects, which can include anxiety, constipation, thoughts of suicide, insomnia, and weight gain.
A recent study reported on the association between the use of selective serotonin reuptake inhibitor (SSRI)
antidepressants during pregnancy and the risk of autism and developmental delay in boys [Harrington
RA, et al. Pediatrics 2014;133(5)]. One extremely common adverse effect that afflicts as many as 80%
of individuals who take antidepressants is sexual dysfunction [Csoka A, et al. Journal of Sexual Medicine
2007;5(1)].
In fact, while antidepressants often lose their efficacy over the course of treatment, their sexual side effects
can continue long after -—even years after—- drug use is discontinued.
Saffron
Saffron (Crocus sativus) is a plant, the dried stigmas (thread-like parts of the flower) of which are used
to make saffron spice. It can take 75,000 saffron blossoms to produce a single pound of saffron spice.
Saffron is largely cultivated and harvested by hand with the bulk of global supply coming from Spain
and Iran. It is believed that Iran produces up to 90% of the world’s saffron. Due to the labour involved in
harvesting, saffron is considered one of the world’s most expensive spices.
Not only are the stigmas used for spice but they are also used in the production of medicine. Saffron has
long been used in traditional medicine around the world, and modern scientific study is verifying that
saffron has health benefits and disease fighting ability. It is believed that crocin, safranal and picrocrocin are
the isolated compounds responsible for saffron’s therapeutic benefit. Saffron has been used in traditional
medicine for suppressing cramps, treating respiratory disorders, coughs and colds, scarlet
fever, smallpox, cancer, hypoxia, and asthma. Scientific evidence today shows
its potential as an anticonvulsant, a free radical scavenger and antioxidant,
a cytotoxic agent against cancer cells (in vitro), and
increases the level of serotonin in the brain.
Saffron has been prized since ancient Persian times as a
way to enhance mood, relieve stress and as an aphrodisiac.
Modern science, through clinical research and data, is now
confirming saffron’s effective ability to enhance mood safely.
This has led to the development of a standardized saffron
extract, for therapeutic and measured use.

Felix utilises a clinically studied, high potency,
proprietary extract of saffron. This exclusive extract
provides:
Proven efficacy.
Standardized pharmaceutical quality.
Safety.
30mg of saffron extract per capsule.
High potency delivering 3% crocin and 2%
safranal.
Felix provides an innovative solution which is:
Scientifically and clinically based.
Safe to use within the recommended daily
intake.
No known contra-indications.
Can be used on its own or as an adjunct to
other forms of treatment.
Saffron has been shown to work directly on
serotonin and dopamine.
Balance Brain Chemistry with Saffron
• Chemical antidepressant drugs are taken by 11% of Americans, 90% of whom suffer at least one of the
numerous adverse effects that range from convulsions to abnormal bleeding to sexual dysfunction.
• An increasing number of studies demonstrate that saffron treats depression with equal success but
without risky side effects.
• Research reveals that saffron also successfully treats other conditions for which antidepressant
medications are used including anxiety, Alzheimer’s disease and obsessive-compulsive disorder.
• Research evidence now shows that when saffron is added to the regimen of male and female patients
already taking antidepressants, it reverses some of the sexual side effects associated with these drugs.

Study 1
Comparison of Crocus sativus L. and imipramine in the treatment of mild to moderate depression: a pilot
double-blind randomized trial.
Akhondzadeh S, et al. BMC Complementary and Alternative Medicine 2004;4(12).
Hamilton Depression Score
22
20
18
16
14
12
10
8
6
Background:
ns
ns
0
**
***
***
***
***
***
1 2 3 4 5 6 7
Trial (week)
*** ns ***
ns
***
The objective was to compare the efficacy of stigmas of Crocus sativus (saffron) with imipramine in the
treatment of mild to moderate depression in a 6-week pilot double-blind randomized trial.
***
Cap. Saffron
Cap. Imipramine
Mean ± SEM scores of two
groups of patients on the
Hamilton Depression Rating
Scale. (ns) Non-significant; (**)
P < 0.01 and (***) P < 0.001.
The horizontal symbols (**
and ***) were used to express
statistical significance versus
their respective baseline value
and ns symbols are for between
group comparisons.
Methods:
Thirty adult outpatients who met the Diagnostic and Statistical Manual of Mental Disorders, 4th edition for
major depression based on the structured clinical interview for DSM IV participated in the trial. Patients had
a baseline Hamilton Rating Scale for Depression score of at least 18. Patients were randomly assigned to
receive saffron 30 mg/day (TDS) (Group 1) or imipramine 100 mg/day (TDS) (Group 2) for 6-weeks.
Results:
Both groups showed a significant improvement over the 6 weeks of treatment (P < 0.0001). The difference
between the two protocols was not significant (F = 2.91, d.f. = 1, P = 0.09). Saffron at this dose was found to
be as effective as imipramine in the treatment of mild to moderate depression. In the imipramine group
anticholinergic effects such as dry mouth and sedation were observed more often than was predictable.
Conclusion:
The main overall finding from this study is that saffron may be of therapeutic benefit in the treatment of
mild to moderate depression.

Study 2
Hydro-alcoholic extract of Crocus sativus L. versus fluoxetine in the treatment of mild to moderate
depression: a double-blind, randomized pilot trial.
Noorbala AA, et al. Journal of Ethnopharmacology 2005;97(2).
Hamilton Depression Score
26
24
22
20
18
16
14
12
10
8
6
ABSTRACT
ns
ns
0
**
***
***
***
***
***
*** ns
***
ns
2 4 6 8
Trial (week)
Saffron (Stigma)
30mg/Day
Fluoxetine 20mg/Day
Mean ± SEM scores of two
groups of patients on the
Hamilton Depression Rating
Scale. (ns) Non-significant; (**)
P < 0.01 and (***) P < 0.001.
The horizontal symbols (**
and ***) were used to express
statistical significance versus
their respective baseline value
and ns symbols are for between
group comparisons.
Saffron is the world’s most expensive spice and apart from its traditional value as a food additive, recent
studies indicate several therapeutic effects for saffron. It is used for depression in Persian traditional
medicine. Our objective was to compare the efficacy of hydro-alcoholic extract of Crocus sativus (stigma)
with fluoxetine in the treatment of mild to moderate depression in a 6-week double-blind, randomized
trial. Forty adult outpatients who met the Diagnostic and Statistical Manual of Mental Disorders (fourth
edition) criteria for major depression based on the structured clinical interview for DSM-IV and with mild to
moderate depression participated in the trial. In this double-blind, single-center trial and randomized trial,
patients were randomly assigned to receive saffron 30 mg/day (Group 1) or fluoxetine 20 mg/day (Group 2)
for a 6-week study. At the end of 6 weeks there was no significant difference between the anti-depressant
effect of saffron and of fluoxetine (F = 0.13, d.f. = 1, P = 0.71). There were no significant differences in the
two groups in terms of observed side effects. The results of this study indicate the efficacy of Crocus sativus
in the treatment of mild to moderate depression.

Study 3
Crocus sativus L. in the treatment of mild to moderate depression: a double-blind, randomized and
placebo-controlled trial.
Akhondzadeh S, et al. Phytotherapy Research 2005;19(2).
ABSTRACT
Depression is a serious disorder in today’s society, with estimates of lifetime prevalence as high as 21% of
the general population in some developed countries. As a therapeutic plant, saffron is considered excellent
for stomach ailments and as an antispasmodic, to help digestion and to increase appetite. It is also used for
depression in Persian traditional medicine. Our objective was to assess the efficacy of the stigmas of Crocus
sativus (saffron) in the treatment of mild to moderate depression in a 6-week double-blind, placebocontrolled
and randomized trial. Forty adult outpatients who met the Diagnostic and Statistical Manual
of Mental Disorders (4th edition) criteria for major depression based on the structured clinical interview
for DSM IV participated in the trial. Patients had a baseline Hamilton Rating Scale for Depression score
of at least 18. In this double-blind, placebo-controlled, single-centre and randomized trial, patients were
randomly assigned to receive a capsule of saffron 30 mg [sol] day (Group 1) or a capsule of placebo (BD)
(Group 2) for a 6-week study. At 6 weeks, Crocus sativus produced a significantly better outcome on the
Hamilton depression rating scale than the placebo (d.f. = 1, F = 18.89, p < 0.001). There were no significant
differences in the two groups in terms of the observed side effects. The results of this study indicate the
efficacy of Crocus sativus in the treatment of mild to moderate depression. A large-scale trial is justified.

Study 4
Effect of saffron on fluoxetine-induced sexual impairment in men: randomized double-blind placebocontrolled
trial.
Modabbernia A, et al. Psychopharmacology 2012;223(4).
ABSTRACT
Rationale:
Saffron (Crocus sativus L.) has shown aphrodisiac effects in some animal and human studies.
Objectives:
To assess the efficacy and tolerability of saffron in fluoxetine-related sexual dysfunction.
Methods:
This was a 4-week randomized double-blind placebo-controlled study. Thirty-six married male patients
with major depressive disorder whose depressive symptoms had been stabilized on fluoxetine and had
subjective complaints of sexual impairment entered the study. The patients were randomly assigned to
saffron (15 mg twice per day) or placebo for 4 weeks. International Index of Erectile Function scale was used
to assess sexual function at baseline and weeks 2 and 4.
Results:
Thirty patients finished the study. Baseline characteristics as well as baseline and final depressive
symptoms scores were similar between the two groups. Effect of time × treatment interaction on the
total score was significant [Greenhouse-Geisser-corrected, F (1.444, 40.434) = 6.154, P = 0.009]. By week
4, saffron resulted in significantly greater improvement in erectile function (P < 0.001) and intercourse
satisfaction domains (P = 0.001), and total scores (P < 0.001) than the placebo group. Effect of saffron did
not differ significantly from that of placebo in orgasmic function (P = 0.095), overall satisfaction (P = 0.334),
and sexual desire (P = 0.517) domains scores. Nine patients (60%) in the saffron group and one patient
(7%) in the placebo group achieved normal erectile function (score > 25 on erectile function domain) at the
end of the study (P value of Fisher’s exact test = 0.005). Frequency of side effects were similar between the
two groups.
Conclusions:
Saffron is a tolerable and efficacious treatment for fluoxetine-related erectile dysfunction.

Study 5
Saffron for treatment of fluoxetine-induced sexual dysfunction in women: randomized double-blind
placebo-controlled study.
Kashani L, et al. Human Psychopharmacology 2013;28(1).
ABSTRACT
Objective:
Saffron (Crocus sativus L.) has shown beneficial aphrodisiac effects in some animal and human studies. The
aim of the present study was to assess the safety and efficacy of saffron on selective serotonin reuptake
inhibitor-induced sexual dysfunction in women.
Methods:
This was a randomized double-blind placebo-controlled study. Thirty-eight women with major depression
who were stabilized on fluoxetine 40 mg/day for a minimum of 6 weeks and had experienced subjective
feeling of sexual dysfunction entered the study. The patients were randomly assigned to saffron (30 mg/
daily) or placebo for 4 weeks. Measurement was performed at baseline, week 2, and week 4 using the
Female Sexual Function Index (FSFI). Side effects were systematically recorded.
Results:
Thirty-four women had at least one post-baseline measurement
and completed the study. Two-factor repeated measure analysis
of variance showed significant effect of time × treatment
interaction [Greenhouse-Geisser’s corrected: F(1.580,
50.567) = 5.366, p = 0.012] and treatment for FSFI
total score [F(1, 32) = 4.243, p = 0.048]. At the end
of the fourth week, patients in the saffron group
had experienced significantly more improvement
in total FSFI (p < 0.001), arousal (p = 0.028),
lubrication (p = 0.035), and pain (p = 0.016)
domains of FSFI but not in desire (p = 0.196),
satisfaction (p = 0.206), and orgasm (p =
0.354) domains. Frequency of side effects
was similar between the two groups.
Conclusions:
It seems saffron may safely and
effectively improve some of the
fluoxetine-induced sexual problems
including arousal, lubrication, and
pain.

Study 6
Crocus sativus L. (saffron) in the treatment of premenstrual syndrome: a double-blind, randomised and
placebo-controlled trial.
Agha-Hosseini M, et al. BJOG: An International Journal of Obstetrics & Gynaecology 2008;115(4).
Objective:
The aim of this double-blind and placebo-controlled trial was to investigate whether saffron (stigma of
Crocus sativus L.) could relieve symptoms of premenstrual syndrome (PMS).
Design:
Double-blind, randomised and placebo-controlled trial.
Setting:
Departments of Gynaecology/Obstetrics and Psychiatry, Tehran and Zanjan University of Medical Sciences.
Population:
Women aged 20-45 years with regular menstrual cycles and experience of PMS symptoms for at least 6
months were eligible for the study.
Method:
Women were randomly assigned to receive capsule saffron 30 mg/day (15 mg twice a day; morning and
evening) (group A) or capsule placebo (twice a day) for a two menstrual cycles (cycles 3 and 4).
Main Outcome Measures:
The primary outcome measure was the Daily Symptom Report, and secondary outcome measure was the
Hamilton Depression Rating Scale.
Results:
In this trial, saffron was found to be effective in relieving symptoms of PMS. A significant difference was
observed in efficacy of saffron in cycles 3 and 4 in the Total Premenstrual Daily Symptoms and Hamilton
Depression Rating Scale.
Conclusion:
The results of this study indicate the efficacy of C. sativus L. in the treatment of PMS. However, a tolerable
adverse effects profile of saffron may well confirm the application of saffron as an alternative treatment for
PMS. These results deserved further investigations.

The use of Curcumin in Depression
It has always been believed that the primary cause of depression was connected to disturbances in
monoaminergic neurotransmissions, specifically serotonin. Modern research has indicated that major
depression is in fact connected to multiple biological disturbances, these include:
• Dysregulation of hypothalamus-pituitary-adrenal (HPA) axis. Immune-inflammatory pathways.
• Mitochondrial dysfunction.
• Neuroprogression - pathological reorganisation of the central nervous system.
• Oxidative stress.
With this in mind it then makes sense to consider treatments for depression which not only target
serotonin but the array of other disturbances. Curcumin, one of the most studied phytochemicals of today
has been shown to:
• Modulate immuno-inflammation by acting on COX-2 and NF-kB and lowering. pro-inflammatory
cytokines.
• Modulate HPA activity.
• Influence monoamine transmission through serotonin and dopamine activity.
• Act as a neuroprotective.
A meta-analysis of six published human clinical studies comparing curcumin to placebo concluded that.
curcumin appeared to be safe and well tolerated with significant clinical efficacy in reducing symptoms of
depression. In three of the studies significant anxiolytic effects were also noted.

Using the latest research and understanding of
depression and looking at the multiple causes, Felix
Advanced uses a high potency saffron extract and
curcumin (BCM-95®) in an efficacious and clinically
verified combination.
Targets depression via:
Serotonin and Dopamine.
Modulation of pro-inflammatory cytokines.
Modulation of HPA activity.
Neuroprotection.
Felix Advanced:
15mg high potency saffron (3% crocin, 2%
safranal) per capsule.
250mg curcumin (BCM-95®) per capsule.
Multiple human clinical studies on single
actives and combination.
No known side effects or reported adverse
events.
Actives shown to be safe with concurrent use
of SSRI medication.
Produced under GMP Pharma standards.

Curcumin for the treatment of major depression: a randomised, double-blind, placebo
controlled study.
Lopresti AL, et al. Journal of Affective Disorders 2014;(167).
Study Design
In a randomised, double-blind, placebo-controlled
study, 56 individuals with major depressive disorder
were treated with curcumin (500mg twice daily)
or placebo for 8 weeks. The primary measure was
the Inventory of Depressive Symptomatology
self-rated version (IDS-SR30) and the Speilberger
State-Trait Anxiety Inventory (STAI).
Results
From baseline to week 4, both curcumin and
placebo were associated with improvements
in IDS-SR30 total score and most secondary
outcome measures. From week 4 to 8, curcumin
was significantly more effective than placebo in
improving several mood-related symptoms. Greater
efficacy from curcumin treatment was identified in
a subgroup of individuals with atypical depression.
Curcumin and major depression: a randomised, double-blind, placebo-controlled trial
investigating the potential of peripheral biomarkers to predict treatment response and
antidepressant mechanisms of change.
Lopresti AL, et al. European Neruopyschopharmacology 2015;25(1).
Study Design
In a randomised, double-blind, placebo-controlled
study, 50 individuals with major depressive
disorder were treated with curcumin (500mg twice
daily) for 8 weeks. The primary measure was the
Inventory of Depressive Symptomatology selfrated
version (IDS-SR30)
Results
Compared to placebo, 8 weeks of curcumin
supplementation was associated with elevations
in urinary thromboxane, while placebo
supplementation was associated with reductions
in aldosterone and cortisol. Higher baseline
plasma endothelin-1 and leptin in curcumin treated
individuals was associated with greater reductions in
IDS-SR30 score after 8 weeks of treatment.
The findings demonstrate that curcumin influences
several biomarkers that may be associated with its
anti-depressant mechanisms of action.
Efficacy of curcumin, and a saffron/curcumin combination for the treatment of major
depression: a randomised, double-blind, placebo-controlled study.
Lopresti AL, et al. Journal of Affective Disorders 2017;(1).
Study Design
In a randomised, double-blind, placebo-controlled
study, 123 individuals with major depressive disorder
were allocated to one of four treatment conditions,
comprising placebo, low-dose curcumin (250mg
b.i.d) , high-dose curcumin extract (500mg b.i.d), or
combined low-dose curcumin extract plus saffron
(15mg b.i.d) for 12 weeks. The outcome measures
were the Inventory of Depressive Symptomatology
self-rated version (IDS-SR30) and the Speilberger
State-Trait Anxiety Inventory (STAI)
Results
The active drug treatments (combined) were
associated with significantly greater improvements
in depressive symptoms compared to placebo
(p=031) , and superior improvements in STAI-state
(p

Felix
Product: 30 mg high concentration saffron
extract (3% crocin, 2% safranal) per capsule
Use : 1 capsule per day.
Duration: 4 to 8 weeks
Available in 30s
Felix Advanced
Product: 30mg high concentration saffron
extract (3% crocin, 2% safranal) 250mg
curcumin (BCM-95®) per capsule.
Use: 1 capsule morning and night, with food.
Duration: 4 weeks
Available in 60s

Free From
Sugar, gluten, artificial additives and GMO materials.
Safety
Well tolerated with no reported adverse events in clinical studies using recommended dose. Long history of
use and acceptance worldwide of active constituents.
Quality
Produced under cGMP standards.
Suitable For
Diabetics and vegetarians.
Medicinal Interactions
Anticoagulants and anti-platelet medication: Using curcumin concurrently with anticoagulants and
anti-platelet medication may result in decreased platelet aggregation and possibly the increased risk of
bleeding. These medicines include warfarin, heparin, ticlopidine, enoxaparin, aspirin, clopidogrel, dalteparin
and others.
Pregnancy and Breastfeeding
Do not use if pregnant or breastfeeding, safety in pregnancy and breastfeeding has not been established.
Special Precautions
Surgery: Curcumin usage should be discontinued at least 2 weeks before any elective surgery due to its
antiplatelet (antithrombotic) effect.
Gallstones or Bile Duct Obstruction: Use with caution in individuals with gallstones, curcumin can cause
gallbladder contractions.
Known Symptoms of Overdose and Particulars of its
Treatment
Treatment should be symptomatic and supportive. In the case of accidental overdose of the product,
contact the nearest hospital or poison control centre.
Presentation & Identification
Felix
White glass bottle with metal screw cap containing 30 capsules, clear vegetarian capsule shell (0)
containing white content.
Felix Advanced
White glass bottle with metal screw cap containing 60 capsules, clear vegetarian capsule shell (0)
containing orange/white content.

Notes

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Phone: 021 421 9144
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