| CTRI Number |
CTRI/2025/05/087332 [Registered on: 21/05/2025] Trial Registered Prospectively |
| Last Modified On: |
07/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trail to compare the effect of EasyV-Gel and VWASH in management of Kaphaja Yonivyapad (Vulvovaginal Candidiasis) |
|
Scientific Title of Study
|
A Study To Evaluate the Effect of EasyV-Gel In Comparison With VWASH In Kaphaj Yonivyapad ( Vulvovaginal Candidiasis ) - In Vitro And Randomized Comparative Clinical Study |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NILL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Avni Kantharia |
| Designation |
PG Scholar |
| Affiliation |
Parul Institute of Ayurved and Research |
| Address |
Department of Prasuti Tantra Evum Stree Roga, Parul Institute of Ayurved and Research Parul University P.O Limda Vadodara Gujarat India Pincode-391760
Vadodara
Gujarat
391760
India
Vadodara
GUJARAT
391760
India |
| Phone |
9624443577 |
| Fax |
|
| Email |
dravnikantharia@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abha L Ravi |
| Designation |
Associate Professor |
| Affiliation |
Parul Institute of Ayurved and Research |
| Address |
Department of Prasuti Tantra Evum Stree Roga, Parul Institute of Ayurved and Research Parul University P.O Limda Vadodara Gujarat India Pincode-391760
Vadodara
Gujarat
391760
India
Vadodara
GUJARAT
391760
India |
| Phone |
8281578252 |
| Fax |
|
| Email |
abharavi22@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Avni Kantharia |
| Designation |
PG Scholar |
| Affiliation |
Parul Institute of Ayurved and Research |
| Address |
Department of Prasuti Tantra Evum Stree Roga, Parul Institute of Ayurved and Research Parul University P.O Limda Vadodara Gujarat India Pincode-391760
Vadodara
Gujarat
391760
India
Vadodara
GUJARAT
391760
India |
| Phone |
9624443577 |
| Fax |
|
| Email |
dravnikantharia@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Avni Kantharia Post Graduate Scholar Department of Prasuti Tantra Evum Stree Roga Parul Institute of Ayurved and Research Parul University P.O Limda Vadodara Gujarat India Pincode - 391760 |
|
|
Primary Sponsor
|
| Name |
Dr Avni Kantharia |
| Address |
Department of Prasuti Tantra Evum Stree Roga Parul Institute of Ayurved and Research Parul University P.O Limda Vadodara Gujarat India Pincode - 391760 |
| Type of Sponsor |
Other [Self ] |
|
|
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 |
| Dr Avni Kantharia |
Khemdas Hospital |
OPD No.05 Department of Prasuti Tantra Evum Stree Roga Ground Floor Khemdas Hospital Parul Institute of Ayurved and Research Parul University P.O Kimda Vadodara Gujarat India Pincode-391760
Vadodara
Gujarat
Vadodara
GUJARAT |
9624443577
dravnikantharia@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PIAR-IECHR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N768||Other specified inflammation of vagina and vulva. Ayurveda Condition: YONIROGAH/YONI-VYAPADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: EasyV Gel, Reference: NA, Route: Topical, Dosage Form: Kalka/ Paste, Dose: 0(NA), Frequency: sos, Bhaishajya Kal: Muhurmuhu, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: EasyV Gel for topical application at vulvar region | | 2 | Comparator Arm (Non Ayurveda) | | - | VWash | VWash is a feminine hygiene wash primarily used to maintain the pH balance and overall hygiene of the intimate area |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Diagnosed Patient of Kaphaj Yonivyapada (Vulvovaginal candidiasis)
Married women |
|
| ExclusionCriteria |
| Details |
Women suffering from Diabetes, STD, Hepatitis B, HIV or with known case of any other debilitating disease.
Pregnant woman.
Unmarried
Perimenopausal
Cervical erosion
Patients with IUD
Cervicitis |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| EasyV-Gel more effective than VWASH |
BT=1st day
8th day
AT=15th day
Treatment duration:15 days
Final Assessment: 15th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| EasyV-Gel equally effective than VWASH |
BT=1st day
8th day
AT=15th day
Treatment duration:15 days
Final Assessment: 15th day |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
21/05/2025 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A number of patients present with white discharge per vaginally, itching of vagina and low backache or dull pain in lower abdomen. All these symptoms cause great discomfort to women and hamper their normal activities. It may cause systemic and psychological disorder hence required treatment. Prevalence rate of Vulvo-vaginal candidiasis in Gujrat is 32.7% Need has always been felt to develop certain innovative Ayurvedic treatment modalities for the management of Kaphaja Yonivyapada and candidiasis which could be safe, effective, readily available, cost effective and without any side effect. In comparison to the therapeutic procedures of different systems of medicine, Ayurveda has a potent approach towards the treatment of Kaphaja Yonivyapada by both internal and external medications
|