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临床试验/CTRI/2023/10/059311
CTRI/2023/10/059311尚未招募3 期

A Controlled Comparative Clinical Trial To Evaluate The Effect Of Dantyadi Kashaya Yoni Prakshalana In Shweta Pradara w.s.r. to Candida Vaginitis

Dr Nikita M Magennavar1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年10月30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
40
试验地点
1
主要终点
Effect of trial drug in classical symptoms of Shweta Pradara w.s.r to Candida Vaginitis i.e.,

研究概览

简要总结

·      Abnormal vaginaldischarge is a frequent complaint of women seen in the gynecologic clinic. Thedischarge may range from excess of normal to one which is a part of widespectrum of diseases. Candidavaginitis is caused by Candida albicans a gram - positive yeast like fungus. The patientcomplains of vaginal discharge with intense vulvovaginal pruritis. In Ayurveda, the word Shwetapradara has not appeared in the BruhatTrayis. Commentator *Chakrapani,*and Samhitas like Sharangadhra Samhita have used the word Shweta Pradara for white vaginalDischarges. Though Kaphadosha involvementis directly not mentioned but the characteristic clinical feature like Sneha, Sheeta, Shukla, Drava etc are that of Kapha thus Shweta Pradara is a Kaphaja Vyadhi.Since the pruritis is out of proportion to discharge this can be correlated toCandida vaginitis.

·      Panchavalkala Kashaya has been taken as standard drug and the combinationof Guduchi, Triphala and Danti (Dantyadi) Kashaya is takenas trial drug as Dantyadi Kashaya contains the drugs that are mainly Tridoshahara,Krumighna, Vishaghna & Vedanasthapana. Here is an attempt to see andcompare the effect of these formulations in management of Shweta Pradara(Candida vaginitis).

·      This is a randomized comparativeclinical study. Total 40 patients of Shweta pradara who fulfills theInclusion Criteria and having Classical sign and symptoms of Shweta pradara willbe selected from the OPD and Medical camps conducted by SDM Trust’s PadmaAyurvedic Hospital and Research Centre, Terdal. These patients are randomlydivided into two groups A and B. Group A will be given Dantyadi Kashaya yoniprakshalanaand Group B given Panchavalkala Kashayayoniprakshalana. Consent will be taken from patient andCase details will be recorded in separate case report form (CRF).  Total Study duration will be 30 days and contain9 visits (0th– 7thday, 15th day, 30thday), which includes administration of trial drug for 7days and post medicationfollow up on 15th& 30th day. After study, data willbe collected from case report form (CRF) and statistically analysed by usingappropriate parametric and nonparametrictests and results will be obtained. Onthat basis of results, conclusion will be drawn.

·

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

年龄范围
21.00 Year(s) 至 40.00 Year(s)(—)
性别
Female

入选标准

  • •Patients with Pratyatma Lakshana’s of Shweta Pradara tested positive for presence of Candida albicans through Wet Mount Microscopy •Married women •Subjects willing to sign the consent form.

排除标准

  • •Diagnosed case of PCOD, PID, UTI •Patients with Systemic disorders like HTN, DM •K/C/O Congenital abnormalities.
  • •K/C/O Thyroid and Parathyroid diseases, Malignancy •Copper T and OCP using women, Pregnant and Lactating women •K/C/O Cervical Erosion, Cervicitis •K/C/O HIV, Hepatitis B, STD’s.

结局指标

主要结局

Effect of trial drug in classical symptoms of Shweta Pradara w.s.r to Candida Vaginitis i.e.,

时间窗: 15th day, 30th day

2.Yonikandu(Itching).

时间窗: 15th day, 30th day

1.Srava(whiteDischarge).

时间窗: 15th day, 30th day

3. Daurgandhya(FoulSmell).

时间窗: 15th day, 30th day

4.Kati shoola(Backache).

时间窗: 15th day, 30th day

5.Yoni vedana

时间窗: 15th day, 30th day

次要结局

  • Safety of trial drug, adverse reaction & aggravation of symptoms of Shweta Pradara w.s.r Candida vaginitis(1st to 7th day)

研究者

发起方
Dr Nikita M Magennavar
申办方类型
Other [self]

研究点 (1)

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