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临床试验/CTRI/2024/07/071316
CTRI/2024/07/071316尚未招募3 期

A Randomised Controlled Clinical Trial To Study The Effect Of Eladi Choorna Orally In Kaphaj Yonivyapad With Special Reference To Vulvovaginal Candidiasis.

Dr Riddhi Vijay Kadav1 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5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
70

研究概览

简要总结

The prevalence rate of kaphaj yonivyapad (vulvovaginal candidiasis) is 22.3%. Due to wide use of antifungal agent developing resistance among reproductive female is the main problem. Ayurveda is best alternative for this as it helps to break the pathogenesis of disease. Ayurvedic treatment for management of kaphaj yonivyapad could be safe, effective, readily available, cost effective, non-invasive and without any side effect. For the management of kaphaj yonivyapad both oral and local medication with antifungal properties would have great impact. Chemical content of Eladi choorna shows antifungal properties against Candida albicans. Clinical trial to evaluate efficacy of Eladi choorna orally with local therapy of Yoni Dhawan with guduchyadi kwath would be beneficial to expand knowledge about management alternative. As clinical study has not been assessed in kaphaj yonivyapad so it will help to fill the knowledge gap. Including the married female patient having sign and symptoms of kaphaj yonivyapad like vaginal discharge, pruritis vulvae, dull pain between age group of 18-49 year who fulfill clinical diagnostic criteria. Written consent is taken from patient to ensure ethical compliance and transparency in research process. Sample size calculated is 35 each group by using formula by Daniel 1999. Simple random sampling technique will be used. Total 70 number of patients will be divided in two group named as Group A (trial group and Group B (control group).Eladi choorna orally and guduchyadi kwath locally for Yoni Dhawan to group A (Trial group), Pippalyadi choorna orally and guduchyadi kwath for Yoni Dhawan to group B (control group) will be given to patients. Drugs will be purchased from GMC certified pharmacy. Both drugs will be administered for 7 days. All SOP of choorna  preparation and Yoni Dhawan procedure will be followed throughout the clinical trial. Observation will be done on 0th and 7th day of treatment. Result will be drawn on basis of assessment criteria and statistical analysis. Discussion will be done on the basis of observation and result obtained during treatment. Summary will be drawn, and thesis work will be summarized with the help of statistical analysis. Conclusion will be drawn without bias.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 49.00 Year(s)(—)
性别
Female

入选标准

  • married patients having sign and symptoms of kaphaj yonivyapad like Mild vaginal discharge Pruritis vulvae Dull pain.

排除标准

  • Unmarried Pregnant Post natal women known case of diabetes mellitus Infections like HIV Syphilis Herpes genitalia.

结局指标

主要结局

70

时间窗: Baseline, 7th day

次要结局

  • Where the trial group stands in comparison with control group(18 months)

研究者

发起方
Dr Riddhi Vijay Kadav
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Riddhi Vijay Kadav

SMBT Ayurved College and Hospital

研究点 (1)

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