CTRI/2021/01/030354尚未招募未知
An Open Label, Prospective, Single Arm, Non-Randomized, Multi-Centric Pilot Study to Evaluate the Efficacy and tolerability of Dysmegesic in the management of Menstrual Pain in Female Subjects.
Shield Healthcare Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
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. Subjects with either â??Moderateâ?? or â??Severeâ?? dysmenorrhea severity assessment during Visit 1
- •2. Regular menstrual cycles for atleast 6 months
- •3. Subjects with body mass index of 18.50 to 30.00 kg/m2 (Both values inclusive)
- •4. Subjects who understand the nature and purpose of the study and who are willing to comply with study procedures.
- •5. Agrees not to participate in other clinical studies within 30 days after the last administration of the study treatment
- •6. Must be willing and able to give informed consent and comply with the study procedures
排除标准
- •1. Known or suspected secondary dysmenorrhea (major abdominal or pelvic surgery, endometriosis, salpingitis, pelvic inflammatory disease (PID), ovarian cysts, pathological vaginal secretion, chronic abdominal pain, endometriosis, fibroids, obstructive endometrial polyps, cervical stenosis inflammatory bowel disease, irritable bowel syndrome).
- •2. Subjects suffering from mild primary dysmenorrhea.
- •3. Concomitant treatment with oral contraceptives, gonadotrophin releasing hormone agonists and antagonists, antiandrogens, gonadotropins, anti-obesity drugs.
- •4. Recent history of abdominal surgery in the last 6 months.
- •5. Unevaluated gynaecological abnormalities inclusive of oncological diagnosis or suspicion (unexplained vaginal bleeding, cervical dysplasia)
- •6. Gross developmental defect or congenital abnormalities of uterus
- •7. Subjects with uncontrolled hypertension, diabetes or other uncontrolled co-morbidities.
- •8. Pregnant and nursing women or women who have given birth or had a miscarriage.
- •9. Women who have undergone hysterectomy.
- •10. Any history of major systemic illness and significant gastrointestinal & liver disorders, renal disorders, endocrine abnormalities, cardiovascular, respiratory, neuropsychiatric disorders or any other significant medical illness, in view of the investigator.
- •11. Subjects who are contemplating surgery/ pregnancy within 90 days after scheduled end of study treatment
- •12. Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study
- •13. Any additional condition(s) that in the Investigators opinion would warrant exclusion from the study or prevent the subject from completing the study.
研究者
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