CTRI/2020/12/030017已完成未知
A prospective, single-center, Investigator initiated clinical study to evaluate theonset of analgesic effectiveness and safety of combination of Camylofin (50 mg) and nonsteroidalanti-inflammatory agent Mefenamic acid (250 mg) in patients with moderate to severe primaryDysmenorrhea
Dr Pragya Pandey0 个研究点目标入组 140 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 140
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. Perimenopausal women above 18 years of age and below45years of age
- •2. Female patients with primary dysmenorrhea on the 1st or 2nd day of their current menstrual cycle
- •3. History of moderate to severe primary dysmenorrhea during four or more of the previous six menstrual cycles on10-point numeric rating scale
- •4. Patients willing to provide written informed consent
- •5. Female of childbearing potential must have a negative pregnancy test and be nonlactating at screening visit.
- •6. Patient is willing to abstain from alcohol consumption throughout the 12-hour Treatment Period
排除标准
- •1. Female patients with a history of taking Camylofin Dihydrochloride 50 mg, Mefenamic Acid I.P. 250 mg or any other prescription-only and/or non-prescription analgesics, antispasmodics, antidepressants, or antipsychotic medication within the 4 weeks before study enrolment.
- •2. Patients who are determined as being the risk group for COVID-19.
- •3. Female patients on antacids, Antihistaminics, tricyclic antidepressants, phenothiazines, disopyramide, pethidine
- •4. Female patients taking Ace inhibitors, Asprin, Diuretics, Lithium, Methotrexate, Warfarin
- •5. Female patients with positive urine pregnancy test
- •6. Lactating female patients
- •7. Female patients with a history of irregular menstrual cycle in the last 6 months
- •8. Female patients with secondary dysmenorrhea (including the following etiologies: leiomyomata [fibroids], pelvic inflammatory disease, tubo-ovarian abscess, ovarian torsion, endometriosis) 9. Evidence of clinically relevant gynecological, cardiovascular, hematologic, hepatic, gastrointestinal, renal, pulmonary, endocrinologic, neurologic or psychiatric disease, based on a clinical assessment and routine laboratory investigations
- •10. Physical examination suggesting a diagnosis of acute abdomen
- •11. Female patients with a history of upper gastrointestinal bleeding and/or active peptic ulcer
- •12. Females using an Intrauterine Contraceptive Device (IUCD) or currently using an oral contraceptive for less than 3 months, has been on a unstable dose within the last 3 months or has switched from one oral contraceptive to another within the last 3 months or intends to do so in the course of the study
- •13. Cognitive impairment, alcohol abuse, or psychiatric illness that would affect the ability of the patient to complete patient diary and other assessments
- •14. History of hypersensitivity to study drug or any of its ingredients
研究者
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