The Impact of Serelys PMS on Symptoms of PMS
Condition: Premenstrual Syndrome
MeSH terms: Premenstrual Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Placebo; Serelys PMS
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 2 months treatment; 2 months treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 2 months treatment with (Food Supplement - Serelys PMS)
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention