A Prospective, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Safety and Efficacy of FenuSmart in Improving Premenstrual Syndrome, Dysmenorrhea and Sexual Function in Young and Perimenopausal Women
概览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- Akay Natural Ingredients Pvt. Ltd
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Mean change in PMS severity and Dysmenorrhea
概览
简要总结
This is a randomized, double-blind, placebo-controlled, parallel group, clinical interventional study. In order to evaluate the effect of the investigational product (IP) on the study objectives, the study will focus on two age groups: Young women aged 18-39 years and women in the peri-menopause phase aged 40-55 years with 70 subjects in each group. Overall, 140 adult healthy females, meeting all inclusion and no exclusion criteria will be enrolled in the study after signing a written informed consent. After the informed consent process, demographic details such as date of birth, ethnicity and race will be obtained. Medical history including hypertension, diabetes mellitus, chronic liver, gastrointestinal and renal disorders, surgeries, any other clinically significant medical and medication history will be obtained. Subjects found eligible for study participation will be randomized into one of the treatment arms (1:1) as per randomization schedule for a treatment period of three consecutive menstrual cycles. The study consists of four phases over four menstrual cycles, involving six clinical visits and two telephonic assessments.The subjects will be dispensed with the test product as per randomization and will be instructed to consume the IP for three consecutive menstrual cycles, 30 minutes after meal. A subject diary shall be provided to the subjects to record the study product administration, AEs, and concomitant medications details during the study duration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Subjects with regular menstrual cycles 2.Subjects who are able to reliably recall and report PMS symptoms and menstrual pain intensity from at least two of the last three menstrual cycles 3.Subjects with a documented history of mild to moderate PMS and or dysmenorrhea, assessed by PSST score 4.Subjects with a BMI between 18.5 to 29.9 kg per meter square 5.Subjects willing to refrain from taking any medications or supplements during the study 6.Subjects who agree to maintain their usual dietary habits and level of exercise 7.Subjects willing to refrain from taking any medications or preparations to improve PMS during the study 8.Subjects willing to refrain from consuming alcohol 24 hours prior to the visit days 9.Subjects must be willing and able to provide informed consent and comply with the study procedures 10.Subjects must be able to understand and adhere to the study requirements, including consuming the investigational product, attending all scheduled visits, and following study guidelines 11.Females of childbearing age, agree to use approved birth control methods during the study, and have negative UPT at screening 12.A visual analog scale score greater or equal to 4 in young women 13.A visual analog scale score greater or equal to 4 for dysmenorrhea in Perimenopause women 14.Subjects with MRS score 0-4, indicating minimal menopausal symptom burden and eligibility for PMS assessment 15.Perimenopausal symptoms: vasomotor symptoms, psychological symptoms , or genitourinary symptoms in Perimenopause women.
排除标准
- •1.Subjects who use hormonal contraceptives or other hormonal therapies 2.Subjects experiencing oligomenorrhea or irregular menstrual cycle 3.Subjects unable to read and understand the informed consent and study materials 4.Subjects with a history of drug dependence, high alcohol intake , or the use of recreational drugs , or nicotine or caffeine dependence 5.Subjects with chronic medical conditions or medication use that may interfere with study outcomes 6.Subjects with psychiatric diagnoses including generalised anxiety or depression 7.Subjects taking multivitamins, herbal supplements, or other wellness products 8.Subjects suffering from a metabolic disorder and or from severe chronic disease or from a disease found to be inconsistent with the conduct of the study by the investigator 9.Subjects with moderate to severe fatigue or having chronic fatigue syndrome 10.Subjects with a malignant disease or any concomitant end-state organ disease and or laboratory abnormalities considered by investigators to be risky or that could interfere with data collection 11.Subjects who are on anxiolytics, anti-depressants, antipsychotics, anticonvulsants, antihypertensive, centrally acting corticosteroids, opioid pain relievers, hypnotics, and or prescribed sleep medications 12.Subjects with uncontrolled hypertension at screening 13.Subjects who have been involved in a clinical study within the past 30 days 14.Subjects with hypersensitivity or a history of allergy to the study product 15.Any other conditions that, in the investigator’s opinion, would warrant exclusion or prevent the participant from completing the study 16.Subjects with a history of drug and or alcohol abuse at the time of enrolment 17.Subjects who are pregnant, nursing, or planning a pregnancy within the study participation period 18.Subjects who have been treated with any investigational drug or investigational device within a period of 3 months prior to study entry 19.Any additional condition that in the Investigators opinion would warrant exclusion from the study or prevent the subject from completing the study.
结局指标
主要结局
Mean change in PMS severity and Dysmenorrhea
时间窗: Baseline, Cycle 1, Cycle 2, Cycle 3
次要结局
- Mean change in skin parameters(Baseline, Cycle 1, Cycle 2, Cycle 3)
- Mean change in Sexual function(Baseline, Cycle 1, Cycle 2, Cycle 3)
- Mean change in energy and fatigue(Baseline, Cycle 1, Cycle 2, Cycle 3)
- Mean change in quality of life(Baseline, Cycle 1, Cycle 2, Cycle 3)
- Mean change in biomarker levels(Baseline, Cycle 1, Cycle 2, Cycle 3)
- Safety of FenuSmart(Baseline, Cycle 1, Cycle 2, Cycle 3)
研究者
Dr Saumya D S
BGS Global Institute of Medical Sciences