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Pre and Post study to find out the combined effect of Brihati Phaladi Cream external application and Aragvadha Twak kashaya internal administration in itching due to Vulvar Fungal Infection(Yoni Kandu)

Phase 2
Not yet recruiting
Conditions
Candidiasis of vulva and vagina,
Registration Number
CTRI/2020/01/022721
Lead Sponsor
Anjana A
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
Not Yet Recruiting
Sex
Female
Target Recruitment
30
Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Itching using 5 D Itch scale5 D Itch scale on day0 day11 and day22
Secondary Outcome Measures
NameTimeMethod
Quality of Life using Dermatology Life Quality Index (DLQI)DLQI on day0 and day22

Trial Locations

Locations (1)

Amrita School of Ayurveda

🇮🇳

Kollam, KERALA, India

Amrita School of Ayurveda
🇮🇳Kollam, KERALA, India
Anjana A
Principal investigator
9947303070
anjuajith666@gmail.com

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