| CTRI Number |
CTRI/2020/01/022721 [Registered on: 13/01/2020] Trial Registered Prospectively |
| Last Modified On: |
15/11/2025 |
| 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)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
15/01/2020 |
| Date of Study Completion (India) |
21/06/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
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. 30 patients recruited to the study and was successfully completed documenting the effect of trial drug in the condition of Yoni kandu. The study was completed where in null hypothesis was rejected.
|