Premenstrual Syndrome Clinical Trial
Official title:
The Impact of Sérélys PMS, a Herbal Remedy Based on Pollen Extraction and Saffron, on Symptoms of PMS: A Randomized, Double-blinded, Placebo Controlled Study
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.
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