CTRI Number |
CTRI/2020/01/022721 [Registered on: 13/01/2020] Trial Registered Prospectively |
Last Modified On: |
10/01/2020 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Ayurveda |
Study Design |
Single Arm Study |
Public Title of Study
|
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) |
Scientific Title of Study
|
Effect Of Bá¹›hatá¿‘phalÄdi Cream with internal administration of Ä€ragvadha Tvak Kaá¹£Äya in YonÄ«Kaṇá¸u Vulvar Fungal Infection |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
IEC-AIMS-2019-AYUR-157 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Anjana A |
Designation |
Post Graduate Scholar |
Affiliation |
Amrita Vishwa Vidyapeetham |
Address |
Dept. of Stri Roga and Prasuti Tantra
Amrita School of Ayurveda
Amritapuri
Amrita Vishwa Vidyapeetham
India Amrita School of Ayurveda
Amritapuri
Amrita Vishwa Vidyapeetham
India Kollam KERALA 690525 India |
Phone |
9947303070 |
Fax |
|
Email |
anjuajith666@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Hemavathi S K |
Designation |
Professor and HOD |
Affiliation |
Amrita Vishwa Vidyapeetham |
Address |
Dept. of Stri Roga and Prasuti Tantra
Amrita School of Ayurveda
Amritapuri
Amrita Vishwa Vidyapeetham
India Amrita School of Ayurveda
Amritapuri
Amrita Vishwa Vidyapeetham
India Kollam KERALA 690525 India |
Phone |
|
Fax |
|
Email |
drhemavathi.sk@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Anjana A |
Designation |
Post Graduate Scholar |
Affiliation |
Amrita Vishwa Vidyapeetham |
Address |
Dept of Stri Roga and Prasuti Tantra
Amrita School of Ayurveda
Amritapuri
Amrita Vishwa Vidyapeetham
India Amrita School of Ayurveda
Amritapuri
Amrita Vishwa Vidyapeetham
India Kollam KERALA 690525 India |
Phone |
|
Fax |
|
Email |
anjuajith666@gmail.com |
|
Source of Monetary or Material Support
|
Amrita School of Ayurveda
Amritapuri
Amrita Vishwa Vidyapeetham
India |
|
Primary Sponsor
|
Name |
Anjana A |
Address |
Dept. of Stri Roga and Prasuti Tantra
Amrita School of Ayurveda
Amritapuri
Amrita Vishwa Vidyapeetham
India |
Type of Sponsor |
Other [Principal Investigator] |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Anjana A |
Amrita School of Ayurveda |
Dept of Stri Roga and Prasuti Tantra
Amrita School of Ayurveda
Amritapuri
Amrita Vishwavidyapeetham
India Kollam KERALA |
9947303070
anjuajith666@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
IEC-AIMS-2019-AYUR-157 |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: B373||Candidiasis of vulva and vagina, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Non-Randomised controlled clinical trial |
Aragvadha twak kashaya 48 ml BD oral route half hour before food for 21 days.
Brihati phaladi cream tropical application in the affected area BD for 21 days. |
|
Inclusion Criteria
|
Age From |
16.00 Year(s) |
Age To |
50.00 Year(s) |
Gender |
Female |
Details |
Patients diagnosed with vulvar fungal infection(KOH Wet Mount positive)
Women in the age group 16 to 50 years |
|
ExclusionCriteria |
Details |
Diagnosed case of other skin diseases
Diagnosed case of Diabetes Mellitus
Patients on steroid therapy
|
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
Itching using 5 D Itch scale |
5 D Itch scale on day0 day11 and day22
|
|
Secondary Outcome
|
Outcome |
TimePoints |
Quality of Life using Dermatology Life Quality Index (DLQI) |
DLQI on day0 and day22 |
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
Phase of Trial
|
Phase 2 |
Date of First Enrollment (India)
|
15/01/2020 |
Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
Nil |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Vulvovaginal
infections have increased dramatically in terms of its severity and incidence
recently. Dermatophytes are
most common fungal infection globally and according to WHO the prevalence is
20-25%. About75% women show a
vulvovaginal candida episode through their life time and 5-10% will experience
recurrence; more than 4 episodes per year. Hence the vulvar fungal infection if
left untreated it may increase the risk of long term complications due to
ascending infections. Fungal infection of vulva is not a life threatening condition
but itching from it can be very
uncomfortable and there will be significant decrease in quality of life. Yoni
kandu as an individual disease is mentioned in BhaishajyaRatnavali Yonikandu
Chikitsa Prakarana as a Kaphaja vyadhi. In all Samhitas Yonikandu is mentioned
as a symptom of Kaphaja Yoni Vyapat. If it is left untreated it may progress to
other diseases like Acarana, Atyananda, Aticarana and Karnini where Yonikandu
coexists with other symptoms making the
treatment more complicated.While assessing the Ayurvedic
literatures Acharya Susruta in uttaratantra has specifically mentioned a
combination for external application in Yonikandu. And hence through this study
an attempt will be made to develop the combination into a more user friendly
cream form(Brihati phaladi cream) and a combination therapy with internal
medication(Aragwadaha twak kashaya) will be studied on vulvar itch from fungal
infections. 30 patients in the age group 16-50yrs complaining of vulvar itch
with or without discolouration of skin will be selected from the OPD and IPD of Amrita School of
Ayurveda, to be screened by taking skin scrapings of the affected area followed
by KOH wet mount test to diagnose vulvar fungal infection. If the diagnosis is
confirmed treatment will be done on OP basis by providing medicines, Aragwadha twak
kashaya choorna which has to be prepared as decoction [1 pala(48gm) powdered
drugs is to be boiled in 16 parts of water(768ml) and reduced to 1/8
parts(96ml)] for internal administration. Brihati phaladi cream has to be
applied in the affected area twice daily. Medicines will have to be continued
for 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 Life
Quality Index(DLQI) on day 0 and day 22nd
. Followup will be done on 30th day after treatment.
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