| CTRI Number |
CTRI/2026/02/104229 [Registered on: 18/02/2026] Trial Registered Prospectively |
| Last Modified On: |
12/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Clinical Study To Evaluate The Efficacy Of Aragvadhadi Kwath Yonidhavan In Kaphaj Yonivyapad With Special Reference To Vulvovaginal Candidiasis |
|
Scientific Title of Study
|
An Open Randomized Control Clinical Trial TO Evaluate The Efficacy Of Aragvadhadi Kwath Yonidhavan In Kaphaj Yonivyapad With Special Reference To 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 Rahila Nawsheen Afsar Khan |
| Designation |
PG Scholar |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Centre Ashta |
| Address |
Department of Prasuti Tantra evum striroga Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Centre Ashta Tal Walwa Dist Sangli 416301
Sangli MAHARASHTRA 416301 India |
| Phone |
9518734967 |
| Fax |
|
| Email |
rahilakhan1816@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Dilip Vitthal Katare |
| Designation |
Professor Department of Prasuti Tantra evum Striroga |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Centre Ashta |
| Address |
Department of Prasuti Tantra evum striroga Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Centre Ashta Tal Walwa Dist Sangli 416301
Sangli MAHARASHTRA 416301 India |
| Phone |
9881215521 |
| Fax |
|
| Email |
drdilipkatareashta@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Dilip Vitthal Katare |
| Designation |
Professor Department of Prasuti Tantra evum Striroga |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Centre Ashta |
| Address |
Department of Prasuti Tantra evum striroga Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Centre Ashta Tal Walwa Dist Sangli 416301
Sangli MAHARASHTRA 416301 India |
| Phone |
9881215521 |
| Fax |
|
| Email |
drdilipkatareashta@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Centre A/P Ashta Tal walwa Dist Sangli Maharashtra 416301 |
|
|
Primary Sponsor
|
| Name |
Dr Rahila Nawsheen Afsar Khan |
| Address |
Department of Prasuti tantra evum Striroga OPD No 6 Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Centre A/P Ashta Tal walwa Dist Sangli Maharashtra 416301 |
| 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 Rahila Nawsheen Afsar Khan |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Centre Ashta |
Department of Prasuti Tantra evum striroga OPD No 6 Dhanwantari Hospital Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Centre Ashta Tal Walwa Dist Sangli 416301 Sangli MAHARASHTRA |
9518734967
rahilakhan1816@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee of Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Centre Ashta Sangli |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N771||Vaginitis, vulvitis and vulvovaginitis in diseases classified elsewhere. Ayurveda Condition: KAPAJA-YONIROGAH, (2) ICD-10 Condition:N771||Vaginitis, vulvitis and vulvovaginitis in diseases classified elsewhere. 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: Ashtang Hriday Uttarsthan 34/57 , Procedure details: Aragvadh-Nimba-Karanja Kwath Yonidhawan on 6th day of menses.
Follow up on 1st , 3rd , 7th Day during treatment & 15th Day (after treatment) ) (1) Medicine Name: Aargavadh nimb karanj Kwath, Reference: Ashtang Hriday Sutrasthan 15/17-18, Route: Vaginal, Dosage Form: Kwatha/Kashaya, Dose: 1000(ml), Frequency: od, Duration: 7 Days | | 2 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Clotrimazole Pessary, Reference: NA, Route: Vaginal, Dosage Form: Varti/ Suppository, Dose: 100(mg), Frequency: hs, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 7 Days, Reference: NA, Route: -, Dosage Form: Varti/ Suppository, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
1. Married Patients having Kaphaj Yonivyapad i.e
having following signs and symptoms
2. Yonigata shweta picchil strav, Yoni kandu
Yonigat alpavedana
3. Patient selection of vaginal candidiasis will be
confirmed after doing KOH Test |
|
| ExclusionCriteria |
| Details |
1. Unmarried female patients.
2. Known cases of sexually transmitted diseases.
3. Uncontrolled DM & HTN.
4. Pregnant women.
5. Cervical polyp and cervical erosion.
6. Patients with intolerable severe pain (VAS
scale of 8 to 10) will be excluded. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Aragvadhadi kwath yonidhavan is effective in Kaphaj Yonivyapad w.s.r.to VulvoVaginal candidiasis. |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. Aragvadhadi kwath yonidhavan for 7 days increases pH of vagina |
Follow up 1st 3rd 7th day during treatment |
|
|
Target Sample Size
|
Total Sample Size="64" Sample Size from India="64"
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)
|
01/04/2026 |
| 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
|
In Ayurveda, a dedicated section on women’s health uses the
term Yoni vyapad to encompass most gynecological disorder. 20 Yonirogas
(Vinshati Yonivyapad) described in Ayurveda samhita by different Acharyas.
Kaphaj Yonivyapad is one among them having Yonigata Shwetstrav, Yoni kandu and
alpa yonivedana as Pradhan lakshan.
Vulvovaginal candidiasis (VVC), one of the most widespread
fungal infections among women of reproductive age, is most often caused by
Candida albicans. In India, an estimated 30% of women have vaginal candidiasis.
It is characterized by symptoms like vaginal itching, white curd-like
discharge, erythema and discomfort, significantly impacting the quality of
life. Most antifungal regimen treatments are available for vaginal candidiasis
can but have chance of side effects as well as recurrences.
The drug Aragvadha, Nimb & karanj having properties
Kaphashamak, Kandughana, Krimighana, Stambhak Vranaropak, Antiseptic. Because of
these properties it helps to overcome the symptoms of Kaphaj Yonivyapad by
increasing local immunity and prevent recurrence of symptoms in patients. |