Clinical trial NCT03298607: The Impact of Serelys PMS on Symptoms of PMS
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Premenstrual Syndrome
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Serelys Pharma
First posted: 2017-10-02
Enrollment: 100
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 months treatment with (Food Supplement - Serelys PMS)
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: PMS symptoms evaluation - Premenstrual Tension
timeFrame: 2 months
measure: PMS symptoms evaluation - Premenstrual Tension 2
timeFrame: 2 months
measure: PMS symptoms evaluation - premenstrual discomfort
timeFrame: 2 months
Secondary outcomes:
measure: Side effect registration
timeFrame: 2 months
measure: Satisfaction scored by the patients
timeFrame: 2 months
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Nutrition, Exercise and Sports, University of Copenhagen
Study officials:
affiliation: UCopenhagen, Department of Nutrition, Exercise and Sport
name: Kaj Winther Hansen, MD
role: STUDY_CHAIR
References: