| CTRI Number |
CTRI/2026/02/104999 [Registered on: 27/02/2026] Trial Registered Prospectively |
| Last Modified On: |
18/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Clinical Study to compare the effectiveness of Triphala Kashaya and Takrayukta Triphala Kashaya vaginal wash in Vulvovaginal Candidiasis |
|
Scientific Title of Study
|
Evaluation of efficacy of Takrayukta Triphala Kashaya Yoni Dhavan in the
management of Kaphaja Yonivyapad with special reference to Vulvovaginal
Candidiasis A Randomized Control Clinical Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Dipti Devidas Phapal |
| Designation |
PG SCHOLAR |
| Affiliation |
Shri B M Kankanawadi Ayurveda Mahavidyalaya Shahapur Belagavi 590003 Karnataka |
| Address |
Department of Prasuti Tantra Evum Streeroga Shri B M Kankanawadi Ayurveda
Mahavidyalaya Shahapur Belagavi 590003
Karnataka
Belgaum
KARNATAKA
590003
India |
| Phone |
7028393184 |
| Fax |
|
| Email |
diptiphapal220799@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gayatri Hubli |
| Designation |
Associate Professor |
| Affiliation |
Shri B M Kankanawadi Ayurveda Mahavidyalaya Shahapur Belagavi 590003 Karnataka |
| Address |
Department of Prasuti Tantra Evum Streeroga Shri B M Kankanawadi Ayurveda
Mahavidyalaya Shahapur Belagavi 590003
Karnataka
Belgaum
KARNATAKA
590003
India |
| Phone |
8970216099 |
| Fax |
|
| Email |
drboradevi13@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gayatri Hubli |
| Designation |
Associate Professor |
| Affiliation |
Shri B M Kankanawadi Ayurveda Mahavidyalaya Shahapur Belagavi 590003 Karnataka |
| Address |
Department of Prasuti Tantra Evum Streeroga Shri B M Kankanawadi Ayurveda
Mahavidyalaya Shahapur Belagavi 590003
Karnataka
Belgaum
KARNATAKA
590003
India |
| Phone |
8970216099 |
| Fax |
|
| Email |
drboradevi13@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
KLE Ayurveda Hospital |
| Address |
Shri B M Kankanawadi Ayurveda
Mahavidyalaya Shahapur Belagavi 590003
Karnataka |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Dipti Devidas Phapal |
KLE Ayurveda Hospital |
OPD number 23 Department of Prasutitantra evum Streeroga
Belgaum
KARNATAKA |
7028393184
diptiphapal220799@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Research on Human Subjects |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:B373||Candidiasis of vulva and vagina. Ayurveda Condition: YONIROGAH/YONI-VYAPADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | yoni dhAvana, योनि धावन | (Procedure Reference: Ashtanga Sangraha Utttarsthana Guhyaroga pratisedha adhyaya 39/94, Procedure details: Yoni Dhavana once a day for seven day)
(1) Medicine Name: Takrayukta Triphala Kashaya, Reference: Ashtanga Sangraha Utttarsthana Guhyaroga pratisedha adhyaya 39/94, Route: Vaginal, Dosage Form: Kwatha/Kashaya, Dose: 1000(ml), Frequency: od, Duration: 7 Days | | 2 | Comparator Arm | Procedure | - | yoni dhAvana, योनि धावन | (Procedure Reference: Ashtanga Sangraha Utttarsthana Guhyaroga pratisedha adhyaya 39/37, Procedure details: Yoni Dhavana once a day for seven day)
(1) Medicine Name: Triphala Kashaya, Reference: Ashtanga Sangraha Utttarsthana Guhyaroga pratisedha adhyaya 39/37, Route: Vaginal, Dosage Form: Kwatha/Kashaya, Dose: 1000(ml), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Patient fulfilling the diagnostic criteria
Female patient aged between 18 to 45 years
Married women
Subject willing to participate in the study |
|
| ExclusionCriteria |
| Details |
Unmarried women
Pregnant and Lactating women
Known case of Diabetes Mellitus Thyroid dysfunction Subject on Hormonal Therapy
Subject who had Oral and local corticosteroids for less than past 6 months |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Significant reduction in srava kandu associated with Kaphaja yonivyapad in the group receiving Takrayukta Triphala Kashaya Yoni Dhavan as compared to the group receiving Triphala Kashaya Yoni Dhavan alone |
0th day 1st day 2nd day 3rd day 4th day 5th day 6th day 7th day and 14th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Takrayukta Triphala Kashaya Yoni Dhavan will show greater reduction in associated symptoms compared to Triphala Kashaya Yoni Dhavan |
0th day 1st day 2nd day 3rd day 4th day 5th day 6th day 7th day and 14th day |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
01/03/2026 |
| 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 Yet Recruiting |
| 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
|
Vulvovaginal Candidiasis is a common infection affecting women worldwide. Estimated to be the second most common cause of vaginitis after bacterial vaginosis. Prevalence of Reproductive tract infection was 37.0% based on symptoms and 36.7% based on laboratory investigations including 31% Candidiasis. Ayurveda classics have enumerated most of the Gynaecological disorders under the entity of Vimshanti Yonivyapada Kaphaja Yonivyapad is one among them presenting Lakshanas Yonigata Picchila Shweta Srava Yonikandu Pradhanlakshana Considering these Lakshanas similar to the clinical features of Vulvovaginal Candidiasis it can be compared with Kaphaja Yonivyapad. Most antifungal regimen treatments are available for vaginal candidiasis but have chances of side effects as allergic response or irritation. Hence an effort is made to manage this condition through the principles of Ayurveda. As there is no Yonivyapad without vitiation of Vata and Kaphaja Yonivyapad is caused due to Kapha Dushti therefore Kaphaghna Kandughna and Vatanulomana chikitsa will be the line of the management. Among various treatments Sthanika Chikitsa is one of treatment modalities which is beneficial. |