| CTRI Number |
CTRI/2026/02/104898 [Registered on: 26/02/2026] Trial Registered Prospectively |
| Last Modified On: |
24/02/2026 |
| 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
|
“Effect of AYU-SHE Herbal Vaginal Wash in the Management of Vaginal Discharge and Infection: A Clinical Study.” |
|
Scientific Title of Study
|
A Single Blind Randomized Control Clinical Trial to Evaluate the Efficacy of AYU SHE Vaginal Wash in Kaphaj Yoni Vyapad W S R to Vulvovaginitis |
| 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 Sheereen Farooqui |
| Designation |
PG Scholar |
| Affiliation |
Parul Institute of Ayurved Parul University Vadodara Gujarat India |
| Address |
Room no 309 Department of Prasuti Tantra and Stree Roga Parul Institute of Ayurved Parul University Vadodara Gujarat India
Vadodara Gujarat India 391760
Vadodara
GUJARAT
391760
India |
| Phone |
9755936789 |
| Fax |
|
| Email |
sheereensheikh.077@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mauli Vaishnav |
| Designation |
Associate Professor |
| Affiliation |
Parul Institute of Ayurved Parul University Vadodara Gujarat India |
| Address |
Room no 309 Department of Prasuti Tantra and Stree Roga Parul Institute of Ayurved Parul University Vadodara Gujarat India
Vadodara Gujarat India 391760
Vadodara
GUJARAT
391760
India |
| Phone |
9589788336 |
| Fax |
|
| Email |
mauli.vaishnav36886@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mauli Vaishnav |
| Designation |
Associate Professor |
| Affiliation |
Parul Institute of Ayurved Parul University Vadodara Gujarat India |
| Address |
Room no 309 Department of Prasuti Tantra and Stree Roga Parul Institute of Ayurved Parul University Vadodara Gujarat India
Vadodara Gujarat India 391760
Vadodara
GUJARAT
391760
India |
| Phone |
9589788336 |
| Fax |
|
| Email |
mauli.vaishnav36886@paruluniversity.ac.in |
|
|
Source of Monetary or Material Support
|
| Parul Institute of Ayurved Parul University Vadodara Gujarat 391760 |
|
|
Primary Sponsor
|
| Name |
Parul Institute of Ayurved Parul University |
| Address |
Parul University Vadodara Gujarat India 391760 |
| 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 Sheereen Farooqui |
Parul Institute of Ayurved Parul University |
Room no 309 Department of Prasuti Tantra and Stree Roga Parul Institute of Ayurved Parul University Vadodara Gujarat 391760
Vadodara
GUJARAT |
9755936789
sheereensheikh.077@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Parul Institute of Ayurved Parul University Vadodara |
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: KAPAJA-YONIROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: AYU SHE Vaginal Wash, Reference: NA, Route: Vaginal, Dosage Form: Sprays, Dose: 00(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: Dose will be decided after Anti-microbial study | | 2 | Comparator Arm (Non Ayurveda) | | - | V Wash | (1) Medicine Name- V Wash, Reference-NA, Route-Vaginal, Dosage Form-Liquid, Dose-3-4 Drops, Frequency- BD, Duration- 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
Married female
Diagnosed with symptoms like P/V Discharge, Itching, Burning, Oduor, Pain, Irritation
Lower backache
Willing to participate and provide informed consent
Above all or minimum 2 symptoms would be taken for inclusion criteria
|
|
| ExclusionCriteria |
| Details |
Patient age group of 55 years above and below 18 years
Unmarried female
During menstrual bleeding
k/c/o- Pelvic inflammatory disorder
k/c/o- Sexually transmitted infection like gonorrhea, syphilis, HIV
Patient not willing to participate and provide informed consent |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the clinical efficacy of AYU SHE Vaginal Wash in relieving the signs and symptoms of Kaphaj yoni vyapad |
day 0 day 7 day 14 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To explore the Anti microbial & Anti inflammatory properties of the herbal ingredients in AYU SHE vaginal wash |
day 0 day 7 day 14 |
|
|
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)
|
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 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
|
The volunteers will be informed about study protocol and willing participants will be selected The clinical research format will be prepared and the study approval will be taken from IEC PIA Parul University Vadodara Gujarat and CTRI registration will be done Then each individual participants will be selected according to selection criteria Participants will be divided in two different groups one group will receive AYU SHE Vaginal wash and another group will receive V Wash twice a day It will include 7 days treatment and follow up |