The Impact of Serelys PMS on Symptoms of PMS

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.

Study Overview

• Status: Completed
• Conditions: Premenstrual Syndrome
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Serelys PMS

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 3

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 1958FC
    • Department of Nutrition, Exercise and Sports, University of Copenhagen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 48 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; 2 capsules daily for 2 months containing inactive substances	Dietary supplement: Placebo; 2 months treatment
Active Comparator: Serelys PMS; 2 capsules daily for 2 months containing pollen extract	Dietary supplement: Serelys PMS; 2 months treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PMS symptoms evaluation - Premenstrual Tension	Premenstrual Tension Scale (PMTS) - Self-rating scale	2 months
PMS symptoms evaluation - Premenstrual Tension 2	Premenstrual Tension Scale (PMTS) - Observe Rating Scale	2 months
PMS symptoms evaluation - premenstrual discomfort	Evaluation of premenstrual discomfort by Visual Analog Scales (VAS)	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Side effect registration	Tolerance will be assessed through a scoring system	2 months
Satisfaction scored by the patients	Satisfaction and well-being will be assessed through a scoring system	2 months

Collaborators and Investigators

• Sponsor: Jens Rikardt Andersen
• Collaborators: Serelys Pharma
• Investigators: Study Chair: Kaj Winther Hansen, MD, UCopenhagen, Department of Nutrition, Exercise and Sport

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2017
• Primary Completion (Actual): June 1, 2018
• Study Completion (Actual): June 1, 2018

Study Registration Dates

• First Submitted: September 7, 2017
• First Submitted That Met QC Criteria: September 29, 2017
• First Posted (Actual): October 2, 2017

Study Record Updates

• Last Update Posted (Actual): October 15, 2018
• Last Update Submitted That Met QC Criteria: October 12, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Menstruation Disturbances; Premenstrual Syndrome
• Other Study ID Numbers: H-17014613

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No