Clinical Evaluation of the Efficacy of a Food Supplement in Relieving Premenstrual Syndrome (PMS) Symptoms: a Randomized, Double-blind, Parallel-group, Placebo-controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Activ'inside
- 入组人数
- 110
- 试验地点
- 6
- 主要终点
- PAF-SF
研究概览
简要总结
The aim of this clinical trial, funded by Activ'Inside, is to evaluate the efficacy of a food supplement in relieving Premenstrual Syndrome (PMS) Symptoms. The study will be performed on 110 healthy women who experience mild/moderate Premenstrual Syndrome (PMS) symptoms, under the supervision of a board-certified Gynecologist. Half of the subjects will assume the active product and half of the subjects will assume a placebo (a product without active ingredients). Specific assessments will be carried out before and after 1, 2 and 3 menstrual cycles of product intake. Also, the possible occurrence of adverse events will be recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy female subjects
- •Caucasian ethnicity
- •Subjects of childbearing age, between 18 and 45 years (extremes included)
- •Subjects who experience mild/moderate Premenstrual Syndrome (PMS) symptoms for at least 3 menstrual cycles prior the beginning of the experimental phase of the study*
- •Subjects who have regular menstrual cycles: 21- to 35-day intervals between two menstrual cycles and a menstrual flow duration of 2-8 days**
- •Normal weight (BMI greater than or equal to 18.5 to 24.9 kg/m2) ***
- •Subjects registered with National Health Service (NHS)
- •Subjects certifying the truthfulness of the personal data disclosed to the investigator
- •Subjects able to understand the language used in the investigation centre and the information given by the investigator
- •Subjects able to respect the instructions given by the investigator as well as able to respect the study constraints and specific requirements
- •Commitment not to change the daily routine or the lifestyle
- •Stable pharmacological therapy (except for the pharmacological therapy in the non-inclusion criteria) for at least one month without any changes expected or planned during the study
- •Subjects informed about the test procedures who have signed a consent form.
- •Assessed by the psychologist using the Premenstrual Symptoms Screening Tool (PSST), a validated self-assessment questionnaire designed to identify women experiencing Premenstrual Syndrome (PMS). The PSST includes questions addressing physical, psychological, and behavioural symptoms. Participants will complete the questionnaire for three consecutive months, and the psychologist will confirm whether they suffer from mild to moderate PMS.
- •Verified by a diary in which participants record this information. Subjects complete the diary for three consecutive months.
- •According to the World Health Organization (WHO) BMI Classification.
排除标准
- •Subjects who do not meet the inclusion criteria
- •Subjects in the perimenopausal period
- •Subjects with any acute, chronic, or progressive disease or condition that may interfere with the study data or that the investigator considers dangerous to the subject or incompatible with the requirements of the study****
- •Subjects participating or planning to participate in other clinical trials
- •Subjects who participated in a similar study without respecting an adequate washout period (at least one month)
- •Subjects that have food intolerances or food allergies to ingredients of the study product
- •Subjects under pharmacological treatments that are considered incompatible with the study requirement by the investigator*****
- •Subjects who are currently using food supplement(s) and/or products with the same activity as the study product, or who haven't observed an adequate washout period (at least one month)
- •Subjects admitted to a health or social facility
- •Subjects planning a hospitalization during the study
- •Subjects not able to be contacted in case of emergency
- •Subjects deprived of freedom by administrative or legal decision or under guardianship
- •Subjects with a history of drug, alcohol and other substance abuse
- •Subjects with eating disorders (i.e. bulimia, psychogenic eating disorders, etc.)
- •Subject breastfeeding, pregnant or not willing to take necessary precautions to avoid pregnancy during the study (for the women of childbearing potential).
- •Polycystic ovary syndrome, endometriosis, thyroid disease, chronic fatigue syndrome, irritable bowel syndrome (IBS), psychiatric disorder (including depression, anxiety, bipolar).
- •Anti-depressants, anxiolytics, diuretics, hormonal contraceptives, nonsteroidal anti-inflammatory drugs.
研究组 & 干预措施
Active product
Hard shell capsule containing active compound.
干预措施: plant extract (Dietary Supplement)
Control product
Hard shell capsule containing maltodextrine
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
PAF-SF
时间窗: From enrollment to 4, 8, 12 weeks after supplementation
The Premenstrual Assessment Form Short Form (PAF-SF) is a standardized questionnaire designed to evaluate the severity and impact of premenstrual syndrome (PMS) symptoms. The total score can range from 10 to 60 points, with higher scores indicating greater severity of symptoms.
PAF-SF
时间窗: From enrollment to 4, 8, 12 weeks after supplementation
The Premenstrual Assessment Form Short Form (PAF-SF) is a standardized questionnaire designed to evaluate the severity and impact of premenstrual syndrome (PMS) symptoms. The total score can range from 10 to 60 points, with higher scores indicating greater severity of symptoms.
次要结局
- PHQ-4(From enrollment to 4, 8, 12 weeks after supplementation)