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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¿‘phalādi Cream with internal administration of Ä€ragvadha Tvak Kaṣāya in YonÄ«Kaṇḍu 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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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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