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临床试验/NCT03298607
NCT03298607已完成3 期

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

Jens Rikardt Andersen2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年10月30日最近更新:
适应症
干预措施

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
100
试验地点
2
主要终点
PMS symptoms evaluation - Premenstrual Tension 2

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

Placebo controlled

入排标准

年龄范围
21 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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:
  • Deterioration in relations with the family, at home, in school or at work
  • Having thought to take painkillers for at least one menstrual cycle.
  • Have symptoms of dysphoria / premenstrual sadness at least during the previous 6 cycles.

排除标准

  • 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.

研究组 & 干预措施

Placebo

Placebo Comparator

2 capsules daily for 2 months containing inactive substances

干预措施: Placebo (Dietary Supplement)

Serelys PMS

Active Comparator

2 capsules daily for 2 months containing pollen extract

干预措施: Serelys PMS (Dietary Supplement)

结局指标

主要结局

PMS symptoms evaluation - Premenstrual Tension 2

时间窗: 2 months

Premenstrual Tension Scale (PMTS) - Observe Rating Scale

PMS symptoms evaluation - premenstrual discomfort

时间窗: 2 months

Evaluation of premenstrual discomfort by Visual Analog Scales (VAS)

PMS symptoms evaluation - Premenstrual Tension

时间窗: 2 months

Premenstrual Tension Scale (PMTS) - Self-rating scale

次要结局

  • Satisfaction scored by the patients(2 months)
  • Side effect registration(2 months)

研究者

发起方
Jens Rikardt Andersen
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Jens Rikardt Andersen

Adj Professor, Department of Nutrition, Exercise and Sports

University of Copenhagen

研究点 (2)

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