CTRI/2019/12/022257已完成4 期
An Open-label, Multicentric, Non-comparative, observational, Phase-IV Clinical Trial toEvaluate Safety, Tolerability and Efficacy of Oral Tablets of Fixed-dose Combination ofCamylofin Dihydrochloride 50 mg and Paracetamol IP 325 mg in the treatment of PrimaryDysmenorrhoea, Colicâ??
试验速览
- 阶段
- 4 期
- 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)Subjects in the age group of 18-45 years (with painful menses)
- •2)Written and/or witnessed informed consent to participate in the trial was taken prior to initiating the study from the parent and/ or the legally accepted representative.
- •3)Patients who had at least 6 months previous history of confirmed diagnosis of Primary Dysmenorrhoea, colic
排除标准
- •1)Not willing to sign ICF
- •2)Patients known, or thought to be hypersensitivity, to study drugs
- •3)Pregnant and lactating women
- •4)Patients with a history of hypersensitivity to Camylofin or Paracetamol
- •5)Patients with prostatic hypertrophy
- •6)Patients with glaucoma
- •7)Patients with mechanical stenosis
- •8)Patients with serious underlying organic disorders
- •9)Patients with paralytic ileus
- •10)Patients with renal or hepatic disorders
- •11)Patients with previous history of heart problems or stroke
- •12)Participation in other clinical trials the last three months and doing study
研究者
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