The Impact of Serelys PMS on Symptoms of PMS
The Impact of Serelys PMS on Symptoms of PMS
The objective of the present study is to better define and evaluate Serelys PMS in terms of
 the impact on the different premenstrual syndrome (PMS) symptoms , tolerance, satisfaction
 and overall quality of life of women with known discomforts during the premenstrual period.
 The data from this study will be compared to data when the two different ingredients are
 given as monotherapy.
More than every other women aged 15 to 50 years of age have premenstrual symptoms such as
 irritability, mood swings, fatigue, headaches, sleep disturbances, breast and abdominal pain,
 bloating, water retention and weight gain. Some signs continue during menstruation. These
 psychological and physical manifestations can make women vulnerable and have a negative
 impact on their professional, social and sexual life. Randomized, double-blind,
 placebo-controlled clinical studies demonstrated the beneficial effects of pollen extract in
 premenstrual discomfort. The premenstrual period is probably caused by a change in the normal
 amount of sex hormones which can induce disorders in the central neuroendocrine system and
 estrogens are reported to reduce PMS symptoms to some extend. Moreover, it is well
 established that serotonin may play a role in PMS, as some inhibitors of serotonin re-uptake
 (SSRI) have an impact on premenstrual disorders. However, side effects may occur even when
 using estrogens as well as SSRI. Recently the pollen extract formulation has been improved by
 adding a natural extract of saffron. This latter component is known for its beneficial action
 on maintaining comfort during the menstrual cycle of the woman and it especially supports
 mood changes, one of the mayor PMS symptoms. The effect of Safran was studied more
 specifically in a randomized controlled double-blind, placebo-controlled clinical trial in
 women with premenstrual discomfort. This study showed a progressive and significant
 improvement after the use of saffron. In an other study saffron was documented to improve
 mood in patients with milder depression.

 In summary, the components of saffron helps to improve the well-being of women during the
 premenstrual and menstrual period and have a well documented impact on mood. The pollen based
 extracts have well documented impact on most of PMS symptoms but possibly lesser on mood
 changes, which is also one of the mayor symptoms of PMS. The mechanisms by which saffron and
 pollen based extraction works is expected to be different and an additive impact is expected.
 The investigation is initiated by the researchers who feel that in PMS an alternatives to
 SSRI and estrogen treatment is needed.
Inclusion Criteria:

 -  At least five inconveniences in the premenstrual period and which disappear quickly
 with the end of menstruation : Irritability, Tension, Fatigue, Dysphoria (sadness),
 Reduced motor coordination, Difficulty concentrating, Changes in libido, Changes in
 appetite.

 -  these inconveniences disappear quickly with the end of menstruation

 -  At least one of these criteria must be present in the premenstrual and menstrual
 period:

 1. Deterioration in relations with the family, at home, in school or at work

 2. Having thought to take painkillers for at least one menstrual cycle.

 -  Have symptoms of dysphoria / premenstrual sadness at least during the previous 6
 cycles.

 Exclusion Criteria:

 -  Known allergy to any component of the product and known renal and hepatic impairment.

 -  Existence of major evolving pathologies

 -  Convulsions. Existence of psychiatric disorders, cravings

 -  Suicidal thoughts

 -  Taking medications that may interfere with PMS symptoms like eg estrogens.

 -  Participation in another clinical study at the same time.

 -  Pregnancy and / or lactation;

 -  Difficulties to collaborate and difficulties to understand and complete the
 questionnaires.