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.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- 2. Changes in clinical global impression scale(CGI)
研究概览
简要总结
A total of 90 female study participants who are clinically diagnosed to have primary dysmenorrhea will be included in the study. The selection of the patients will be based on initial screening and study criteria.
Group 1- Participants with Primary dysmenorrhea will take one tablet of Releeva 5 premenstrual syndrome tablet orally thrice daily 3 days before menses followed by Releeva 5 Herbal Tea Granules extract twice daily for a period of 5 days during the menstrual cycle.
Group 2 - Participants with Primary dysmenorrhea will take one tablet of Releeva 5 premenstrual syndrome tablet orally thrice daily 3 days before menses followed by topical application of Releeva 5 cramp relief Roll-on oilon the pain affected lower abdomen, thigh and lower back four times daily for a period of 5 days during the menstrual cycle.
Group 3 - Participants with Primary dysmenorrhea will take tablet MEFTAL-SPAS orally 2 times daily for a period of 5 days during the menstrual cycle.
The primary and secondary outcome measures will be monitored over a period of 5 days and follow up for 1 month.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Female participants between the age of 18-45 years (both inclusive) with regular menstrual cycles (21–35 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.
结局指标
主要结局
2. Changes in clinical global impression scale(CGI)
时间窗: Day 1 to day 5
1. Change from baseline in menstrual pain intensity measured by Pain VAS Scale (0-10)
时间窗: Day 1 to day 5
3. Changes from base line in following laboratory parameter(s):
时间窗: Day 1 to day 5
Prostaglandin (PGF2α), Hs-C Reactive Protein, ESR, Serum fibrinogen and Complete Blood Count
时间窗: Day 1 to day 5
次要结局
- 4. Changes from base line in Quality of life- Questionnaires (Short Form Health-12 or 36), Systemic symptoms (VMS)(5. Duration of pain relief in hours (After medication))