CTRI/2020/06/026204已完成3 期
A Randomized, Open Label, Multicentered, Parallel Group Clinical Study To Evaluate The Efficacy And Safety of RELEEVA 5 Cramp Relief Herbal Tea, Roll-On Oil And Tablets In The Management Of Primary Dysmenorrhea and Premenstrual Syndrome.
Tirupati Life Sciences0 个研究点目标入组 90 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
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.Female participants between the age of 18-45 years (both inclusive) with regular menstrual cycles (21â??35 days)
- •who are clinically diagnosed to have primary dysmenorrhea.
- •2.Subjects with stable vitals like pulse and blood pressure
- •3.Patient should have not participated in any other clinical trial during the past 3 months.
- •4.Participants who are willing to give written, signed and dated informed consent to participate in the study.
排除标准
- •1.Secondary dysmenorrhea
- •2.Presence of any other Gynaecological diseases.
- •3.Pregnant or breastfeeding or planning to become pregnant during the study period.
- •4.Known case of Hypersensitivity to Investigational drug content.
- •5.Patients suffering from abnormal haematological or biochemical (renal & liver function) blood parameters.
- •6.Received any other investigational medicine within 7 days prior to screening which can interfere with investigational product activity
- •7.Suffering from any illness which will interfere with present study as decided by clinical investigator
- •8.Any condition decided as unfit for study by Clinical investigator
研究者
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