跳至主要内容
临床试验/CTRI/2020/01/022721
CTRI/2020/01/022721尚未招募2 期

Effect Of Bá¹›hatá¿‘phalÄdi Cream with internal administration of Ä€ragvadha Tvak Kaá¹£Äya in YonÄ«Kaṇá¸u Vulvar Fungal Infection

Anjana A1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年1月15日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
Itching using 5 D Itch scale

研究概览

简要总结

Vulvovaginalinfections have increased dramatically in terms of its severity and incidencerecently. Dermatophytes aremost common fungal infection globally and according to WHO the prevalence is20-25%. About75% women show avulvovaginal candida episode through their life time and 5-10% will experiencerecurrence; more than 4 episodes per year. Hence the vulvar fungal infection ifleft untreated it may increase the risk of long term complications due toascending infections. Fungal infection of vulva is not a life threatening conditionbut itching from it can be  veryuncomfortable and there will be significant decrease in quality of life. Yonikandu as an individual disease is mentioned in BhaishajyaRatnavali YonikanduChikitsa Prakarana as a Kaphaja vyadhi. In all Samhitas Yonikandu is mentionedas a symptom of Kaphaja Yoni Vyapat. If it is left untreated it may progress toother diseases like Acarana, Atyananda, Aticarana and Karnini where Yonikanducoexists with other symptoms making  thetreatment more complicated.While assessing the Ayurvedicliteratures Acharya Susruta in uttaratantra has specifically mentioned acombination for external application in Yonikandu. And hence through this studyan attempt will be made to develop the combination into a more user friendlycream form(Brihati phaladi cream) and a combination therapy with internalmedication(Aragwadaha twak kashaya) will be studied on vulvar itch from fungalinfections. 30 patients in the age group 16-50yrs complaining of vulvar itchwith or without discolouration of skin will be selected  from the OPD and IPD of Amrita School ofAyurveda, to be screened by taking skin scrapings of the affected area followedby KOH wet mount test to diagnose vulvar fungal infection. If the diagnosis isconfirmed treatment will be done on OP basis by providing medicines, Aragwadha twakkashaya choorna which has to be prepared as decoction [1 pala(48gm) powdereddrugs is to be boiled in 16 parts of water(768ml) and reduced to 1/8parts(96ml)] for internal administration. Brihati phaladi cream has to beapplied in the affected area twice daily. Medicines will have to be continuedfor 21 days. Assessment will be done for itching(yoni kandu) on day 0, day 11 and day 22nd by 5 D Itch scale and Quality of life of patients will be assessed using Dermatology LifeQuality Index(DLQI)  on day 0 and day 22nd. Followup will be done on 30th day after treatment.

研究设计

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

入排标准

年龄范围
16.00 Year(s) 至 50.00 Year(s)(—)
性别
Female

入选标准

  • Patients diagnosed with vulvar fungal infection(KOH Wet Mount positive) Women in the age group 16 to 50 years.

排除标准

  • Diagnosed case of other skin diseases Diagnosed case of Diabetes Mellitus Patients on steroid therapy.

结局指标

主要结局

Itching using 5 D Itch scale

时间窗: 5 D Itch scale on day0 day11 and day22

次要结局

  • Quality of Life using Dermatology Life Quality Index (DLQI)(DLQI on day0 and day22)

研究者

发起方
Anjana A
申办方类型
Other [Principal Investigator]

研究点 (1)

Loading locations...

相似试验