跳至主要内容
临床试验/CTRI/2025/04/086042
CTRI/2025/04/086042尚未招募Phase 3 4

An Exploratory Study to evaluate the effect of Chaturbeeja Arka in reducing the pain in PrimaryDysmenorrhea

OTHER1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年5月20日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
OTHER
入组人数
40
试验地点
1
主要终点
Reduction in intensity of pain using the vas scale.

研究概览

简要总结

Primary Dysmenorrhea is a most common disorder that affects upto 70% of the female population. It affects patients with significant impairment in quality of life, sleep,and work performance because of pain. The prevalence of Primary Dysmenorrhea has increased in recent decades due to sedentary lifestyle and unhealthy food habits. Primary Dysmenorrhea can be compared with Udavartini in Ayurveda,which is one of the diseases caused by vitiation of vata and can be treated with vata anulomana drugs. In the proposed research,a short term and more palatable drug approach will be used to treat primary dysmenorrhea. This study aims to assess the effectiveness of interventions with internally administered herbal formulations for better outcomes in the treatment of primary dysmenorrhea.

The study is an exploratory study. A total of 40 patients fulfilling the inclusion criteria will be selected. The treatment protocol comprised Chaturbeeja arka 10 ml  for first three days of menstruation twice orally with equal quantity of water for one menstruation cycle. Patients will be assessed based on Vas score,Cox menstrual symptom scale and VMSS scale. The data will be statistically evaluated with friedman test.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 25.00 Year(s)(—)
性别
Female

入选标准

  • Regular menstrual cycles for three consecutive months having moderate to severe Primary Dysmenorrhea maintaining menstrual history diary or records.Those who have video calling facility on their mobile.

排除标准

  • Participants with genitourinary infection, under hormonal therapy, diagnosed case of pelvic pathology, Plan for conception.

结局指标

主要结局

Reduction in intensity of pain using the vas scale.

时间窗: First three days of menstruation | for one menstrual cycle.

次要结局

  • Reduction in duration of pain and improvement in quality of life using CMSS and VMSS scale respectively(first three days of menstruation cycle twice daily using video calls)

研究者

发起方
OTHER
申办方类型
Private medical college

研究点 (1)

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