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临床试验/CTRI/2024/08/072107
CTRI/2024/08/072107尚未招募3 期

A randomised controlled clinical trial to study the effect of dipyadi Churna In udavartini yonivyapada with special reference to primary dysmenorrhoea.

Dr Priyanka Madan Nagargoje1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年8月18日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
70
试验地点
1
主要终点
Reduction in sign and symptoms of udavartini yonivyapad after giving dipyadi churna

研究概览

简要总结

Prevalence rate of primary dysmenorrhoea is70.2%.Primary dysmenorrhoea is confined to adolescents.The incidence of primary dysmenorrhoea of sufficient magnitude to incapicitation is 15-20%. In modern science first line choice therapy for primary dysmenorrhoea is NSAIDs.They are highly effective, but have their own side effects if used for longer period.The primary treatment for udavartini yonivyapada is vatashaman. Dipyadi churna has properties like vatanuloman,vatashaman,shoolprashaman.As previously no study has been done on dipyadi churna in Udavartini yonivyapada ,so it will be helpful in female between age group 13 to 25 years having sign and symptoms of primary dysmenorrhoea such as painful menstruation,nausea, vomiting suprapubic and lumbosacral pain.Written informed consent will be taken to ensure compliance and transperancy in research process.The sample size calculated 35 in each group by Daniel formula1999.Simple random sampling technique will be used.Total 70 number of patients will be divided into two groups as group A(trial group)and group B(control group). Dipyadi churna to group A and Mefenamic acid to group B.All SOP of churna will be followed throughout the clinical trial.Observation will be done after menstrual cycle.Result will be drawn on the basis of assessment criteria statistical Discussion will be done on the basis of observation and result obtained during treatment.Summary will be drawn,and thesis will be summarised with the help of statistical analysis.Conclusion will be drawn.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

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

入选标准

  • Patient suffering from the symptom like unbearable pain in lower abdomen during menstrual cycles 2) school and college going girls between age 13 to 25 years 3) Patients having regular menstrual cycle with normal amount of menstrual flow (normal 2-3pad/day).

排除标准

  • Patients with secondary dysmenorrhea 2) Patients with IUCD 3) Patient taking contraceptive pills.

结局指标

主要结局

Reduction in sign and symptoms of udavartini yonivyapad after giving dipyadi churna

时间窗: 18months

次要结局

  • Not applicable(Not applicable)

研究者

发起方
Dr Priyanka Madan Nagargoje
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Priyanka Madan Nagargoje

SMBT Ayurved College and Hospital Dhamangaon Nashik

研究点 (1)

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