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
Verified date | October 2018 |
Source | University of Copenhagen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | June 1, 2018 |
Est. primary completion date | June 1, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 21 Years to 50 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Denmark | Department of Nutrition, Exercise and Sports, University of Copenhagen | Copenhagen |
Lead Sponsor | Collaborator |
---|---|
Jens Rikardt Andersen | Serelys Pharma |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | PMS symptoms evaluation - Premenstrual Tension | Premenstrual Tension Scale (PMTS) - Self-rating scale | 2 months | |
Primary | PMS symptoms evaluation - Premenstrual Tension 2 | Premenstrual Tension Scale (PMTS) - Observe Rating Scale | 2 months | |
Primary | PMS symptoms evaluation - premenstrual discomfort | Evaluation of premenstrual discomfort by Visual Analog Scales (VAS) | 2 months | |
Secondary | Side effect registration | Tolerance will be assessed through a scoring system | 2 months | |
Secondary | Satisfaction scored by the patients | Satisfaction and well-being will be assessed through a scoring system | 2 months |
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