CTRI/2020/06/025609已完成不适用
A randomized, double-blind, placebo-controlled, parallel study of Lomens-P0 to evaluate the efficacy and safety on healthy subjects with Premenstrual Syndrome (PMS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Clinically significant positive change from baseline to EOT in the Penn State daily Symptom Report (DSR)
研究概览
简要总结
A randomized, double-blind, placebo-controlled, parallel study of Lomens-P0 to evaluate the efficacy and safety on otherwise healthy subjects with Premenstrual Syndrome(PMS) for 12 weeks. The enrolled subjects will be randomised into either of the 2 groups in the ratio of 1:1 for a period of 12 weeks (3 months), as one tablet once a day.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 19.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Women aged 19-45 years
- •Subject who voluntarily agrees to participate and signs in ICF
- •Women who have menstruation
- •Menstrual cycle range not longer than 31 or shorter than 24 days for at least last 6 months
- •Mild to moderate symptoms of premenstrual syndrome (score ≥16), identified by the DSR and Follicular score less than 40 identified by the COPE.
- •The scores will be calculated by averaging the scores of six days before 1st day of menstruation for 2 consecutive menstrual cycle from visit 1 to visit 2.
排除标准
- •Subject who took medicine or health functional food related to PMS
- •Subject with a history of uterine cancer and sex hormone-related cancer, or undiagnosed uterine bleeding
- •Subject with a severe migraine or diagnosed with thromboembolism, cerebrovascular disease, myocardial infarction, unstable angina, or a history of coronary angioplasty within a year
- •Subject with severe mental illness, such as depression and anxiety disorder, or who is currently taking neuro-psychotic drug such as antidepressants
- •Uncontrolled hypertension disease(160/100 mmHg and above)
- •Uncontrolled thyroid disease
- •Drug or alcohol abusers
- •Participated in another clinical trial within one month of the start of this clinical trial, or plan to participate in another clinical trial during the trial
- •Any condition that in the opinion of the investigator does not justify the subject’s inclusion for the study
- •Subject who uses sanitary aids or extra equipment (e.g. Hot water bottle, Instant hot pack, Heating pad (electronical) to abdomen and lumbar, Instant ice pack to limbs) to relieve PMS
- •Subject who plans to conceive within 3 months, Breastfeeding women and pregnant woman
- •Actual or recent participation in psychotherapy due to premenstrual symptoms
- •Allergy with any of the ingredients of the IP
- •Women who are surgically sterilised, hysterectomised, or ovariectomised
- •Subjects on the treatment of infertility
- •Any gynaecological disease like cysts, fibroids, malignancy.
- •Woman reaching menopause
- •Subjects using hormonal contraception.
结局指标
主要结局
Clinically significant positive change from baseline to EOT in the Penn State daily Symptom Report (DSR)
时间窗: 12 weeks
次要结局
- Clinically significant positive change from baseline to EOT (End of treatment) in The Calendar of Premenstrual Experience (COPE) scores(12 weeks)
研究者
研究点 (1)
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