| CTRI Number |
CTRI/2026/02/104830 [Registered on: 26/02/2026] Trial Registered Prospectively |
| Last Modified On: |
25/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To See The Effect Of Takradi Yoga Vaginal Wash In The Management Of Kaphaja Yonivyapad wsr Vulvovaginal Candidiasis |
|
Scientific Title of Study
|
An Open Label Randomized Controlled Clinical Study To Evaluate The Effect Of Takradi Yoga Yoniprakshalana In The Management Of Kaphaja Yoni Vyapat Vis-A-Vis Vulvovaginal Candidiasis |
| 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 Mahalaxmi |
| Designation |
PG Graduate Scholar |
| Affiliation |
JSS Ayurveda Medical College |
| Address |
Department of PG studies in Stree roga and Prasuti tantra, OPD no. 9, JSS Ayurveda Medical College and Hospital, 41 E,Lalithadripura road, Mysuru Karnataka
Mysore
KARNATAKA
570028
India |
| Phone |
9606518767 |
| Fax |
|
| Email |
mahalaxmiambulgl@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vidya Narayan |
| Designation |
HOD & Associate Professor |
| Affiliation |
JSS Ayurveda Medical College |
| Address |
Department of PG studies in Stree roga and Prasuti tantra, OPD no. 9, JSS Ayurveda Medical College, 41 E,Lalithadripura road, Mysuru Karnataka
Mysore
KARNATAKA
570028
India |
| Phone |
9980760076 |
| Fax |
|
| Email |
vidya.dr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mahalaxmi |
| Designation |
PG Graduate Scholar |
| Affiliation |
JSS Ayurveda Medical College |
| Address |
Department of PG studies in Stree roga and Prasuti tantra, OPD no. 9, JSS Ayurveda Medical College, 41 E,Lalithadripura road, Mysuru Karnataka
Mysore
KARNATAKA
570028
India |
| Phone |
9606518767 |
| Fax |
|
| Email |
mahalaxmiambulgl@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Mahalaxmi |
| Address |
Department of PG studies in Stree Roga and Prasooti Tantra, JSS Ayurveda Medical College, 41 E Lalithadripura Road, Mysuru, Karnataka 570028 |
| 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 Mahalaxmi |
JSS Ayurveda Medical College |
Department of PG Studies In Stree Roga And Prasooti Tantra,OPD no. 9, JSS Ayurveda Medical College, 41 E, Lalithadripura Road, Mysuru
Mysore
KARNATAKA |
9606518767
mahalaxmiambulgl@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Clearance Committee - Human |
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: ch.chi.30, Procedure details: Purvakarma :
expalained the procedure to the patient.
Informed consent taken.
after the emptying the bladder patient made to lie in lithotomy position.
pradhana karma :
Wear sterile gloves, clean the genital area with antiseptic decoction.
fill the basti can with medicated liquid.
gently insert catheter into the vaginal canal.
allow slow and the steady flow of the liquid.
Continue irrigation until sufficient cleansing is achieved.
Paschat Karma :
Dry the area with sterile guaze.
patient made to rest for 10 - 15 minutes.)
(1) Medicine Name: Takradi yoga, Reference: ch.chi.30, Route: Vaginal, Dosage Form: Kwatha/Kashaya, Dose: 1000(ml), Frequency: od, Duration: 7 Days | | 2 | Comparator Arm (Non Ayurveda) | | - | Clotrimazole 1 % | Antifungal Gel
Mode of administration : Intravaginally
Dosage : 5gm
Duration : Daily once for 7 days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. Married women
2. Female subjects aged between 18 and 45 years.
3. Subject who fulfilling the diagnostic criteria will be taken |
|
| ExclusionCriteria |
| Details |
1.Unmarried women
2.Known case of malignant condition.
3.Known case of diabetes mellitus
4.Pregnant or Lactating women
5.Those undergoing hormone replacement therapy
6.Subjects who had received oral and topical antifungal treatment or corticosteroids within the last 6 months |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
White vaginal discharge, foul smell and vaginal itching will be reduced and vaginal smear report will be negative for candida albicans
|
Day 0
Day 8th
Day 15th
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| There will neither white disharge nor smell per vagina |
1 month |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
10/03/2026 |
| 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 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
|
This study is an open-label randomized controlled clinical trial designed to evaluate the efficacy of Takradi Yoga Yoni Prakshalana in the management of Kaphaja Yonivyapad, correlated with Vulvovaginal Candidiasis, and to compare its effect with the standard modern treatment Clotrimazole (1 Percent) vaginal gel. Kaphaja Yonivyapad, described in Ayurveda under Vimshati Yonivyapad, is characterized by Picchila Srava (thick discharge), Yoni Kandu (itching), , and Dourgandhya (foul smell) , which closely resemble the clinical features of vulvovaginal candidiasis caused predominantly by Candida albicans. Despite the availability of antifungal therapy in modern medicine, issues such as recurrence, resistance, and side effects necessitate safer and holistic alternatives. Ayurveda emphasizes Sthanika Chikitsa (local treatment) along with Kapha-Vata hara principles. Classical references support Yoni Prakshalana using Takra, Triphala Kwatha, and Gomutra Arka, which possess Kaphaghna, Kandughna, Krimighna, and Shothahara properties. The prepared Takradi Yoga maintains a mildly acidic pH (5–6), favorable for restoring vaginal flora. A total of 40 married women aged 18–45 years, diagnosed with vulvovaginal candidiasis, will be randomly allocated into two groups: Group A (Control): Clotrimazole (1 Percent) vaginal gel for 7 days Group B (Intervention): Takradi Yoga Yoni Prakshalana for 7 days Assessment will be done based on subjective parameters ( vaginal discharge, itching, foul smell) and objective parameters (vulval changes, Quanatity of discharge, vaginal smear positivity for Candida albicans), with follow-up after treatment. The study aims to establish Takradi Yoga Yoni Prakshalana as an effective, safe, and integrative Ayurvedic local therapy for the management of Kaphaja Yonivyapad / Vulvovaginal Candidiasis |