CTRI/2020/06/025609已完成未知
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
- 未知
- 状态
- 已完成
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Women aged 19-45 years
- •2. Subject who voluntarily agrees to participate and signs in ICF
- •3. Women who have menstruation
- •4. Menstrual cycle range not longer than 31 or shorter than 24 days for at least last 6 months 5. Subjectâ??s next approaching menstrual cycle not falling within next 10 days from screening day. 6. 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
- •1. Subject who took medicine or health functional food related to PMS
- •2. Subject with a history of uterine cancer and sex hormone-related cancer, or undiagnosed uterine bleeding
- •3. Subject with a severe migraine or diagnosed with thromboembolism, cerebrovascular disease, myocardial infarction, unstable angina, or a history of coronary angioplasty within a year
- •4. Subject with severe mental illness, such as depression and anxiety disorder, or who is currently taking neuro-psychotic drug such as antidepressants
- •5. Uncontrolled hypertension disease(160/100 mmHg and above)
- •6. Uncontrolled thyroid disease
- •7. Drug or alcohol abusers
- •8. 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
- •9. Any condition that in the opinion of the investigator does not justify the subjectâ??s inclusion for the study
- •10. 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 11. Subject who plans to conceive within 3 months, Breastfeeding women and pregnant woman 12. Actual or recent participation in psychotherapy due to premenstrual symptoms
- •13. Allergy with any of the ingredients of the IP 14. Women who are surgically sterilised, hysterectomised, or ovariectomised
- •15. Subjects on the treatment of infertility
- •16. Any gynaecological disease like cysts, fibroids, malignancy.
- •17. Woman reaching menopause
- •18. Subjects using hormonal contraception
研究者
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