| CTRI Number |
CTRI/2025/07/090525 [Registered on: 09/07/2025] Trial Registered Prospectively |
| Last Modified On: |
08/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
"A study to see how well Yashti Ghrut works in treating vaginal infection and irritation." |
|
Scientific Title of Study
|
Randomized Controlled Clinical Trial To Evaluate The Efficacy Of Yashti Ghrut Paan And Pichu Dharan In The Management Of Pittaj Yonivyapad 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 Purva Sunil Kulkarni |
| Designation |
PG SCHOLAR in prasuti tantra evum strirog |
| Affiliation |
Late Kedari Redekar Ayurved Mahavidyalaya |
| Address |
Late Kedari Redekar Ayurvedic Mahavidyalaya,stree roga evum prasuti tantra OPD no 5 and IPD,Ground floor Late kedari Redekar Ayurved College, Hospital And Research Centre MIDC Shendri Mal, Gadhinglaj, Kolhapur
Late Kedari Redekar Ayurvedic Mahavidyalaya,stree roga evum prasuti tantra OPD no 5 and IPD,Ground floor Late kedari Redekar Ayurved College, Hospital And Research Centre MIDC Shendri Mal, Gadhinglaj, Kolhapur
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
8999287625 |
| Fax |
|
| Email |
purvakulkarni9297@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prasad U Lomate |
| Designation |
BAMS MS PRASUTI TANTRA AVUM STRI ROGA (Proffesor of gynaec department) |
| Affiliation |
Late Kedari Redekar Ayurved Mahavidyalaya |
| Address |
Stree roga evum Prasuti tantra, OPD no. 5 and IPD ground floor, Late Kedari Redekar Ayurvedic Mahavidyalaya, MIDC, Shendri Mal, Gadhinglaj, Kolhapur
Stree roga evum Prasuti tantra, OPD no. 5 and IPD ground floor, Late Kedari Redekar Ayurvedic Mahavidyalaya, Shendri Mal, Gadhinglaj, Kolhapur
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
8275917687 |
| Fax |
|
| Email |
prasad.lomate969@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Purva Sunil Kulkarni |
| Designation |
PG SCHOLAR in prasuti tantra evum strirog |
| Affiliation |
Late Kedari Redekar Ayurvedic Mahavidyalaya |
| Address |
Stree roga evum Prasuti tantra, OPD no. 5 and IPD ground floor, Late Kedari Redekar Ayurvedic Mahavidyalaya, Shendri Mal, Gadhinglaj, Kolhapur
Stree roga evum Prasuti tantra, OPD no. 5 and IPD ground floor, Late Kedari Redekar Ayurvedic Mahavidyalaya, Shendri Mal, Gadhinglaj, Kolhapur
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
8999287625 |
| Fax |
|
| Email |
purvakulkarni9297@gmail.com |
|
|
Source of Monetary or Material Support
|
| Late Kedari Redekar Ayurvedic College And Research Centre, P-2, MIDC, SHendri Mala, Gadhinglaj, 416502 |
|
|
Primary Sponsor
|
| Name |
Dr Purva Sunil Kulkarni |
| Address |
303 A Ashmika heights kale nagar 2 gangapur road nashik 2 pincode 422013 |
| 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 Purva Sunil Kulkarni |
Late Kedari Redekar Ayurvedic Hospital And Research Centre |
Stree roga evum Prasuti tantra, OPD no. 5 and IPD ground floor, Late Kedari Redekar Ayurved Mahavidyalaya Shendri Mal Gadhinglaj ,Kolhapur
Kolhapur
MAHARASHTRA |
8999287625
purvakulkarni9297@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Late Kedari Redekar Ayurvedic Hospital And Research Centre |
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: PITTAJA-YONIROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Amoxicillin capsule and betadine pessary | | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Yashti Ghrut, Reference: Ashtrang Hruday, Route: Oral, Dosage Form: Ghrita, Dose: 12.5(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: -Koshna Jal), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Diagnosed cases of Pittaj yonivyapad (Vulvo-vaginitis).
Patients within the age group of 18-45 years of married womens. |
|
| ExclusionCriteria |
| Details |
Pregnant females.
H/o Diabetes mellitus, thyroid disorders.
Patients with Vulvo-vaginitis when seen associated with prolapsed uterus.
HIV, HBsAg, VDRL Positive.
Patients with benign and malignant tumours of uterus.
Patients who require surgical intervention in cases like pelvic abscess, Tubo ovarian mass
Patients associated with tubercular infections.
Patients with exclusively bartholinitis.
Patients with sexually transmitted diseases,
Post menopausal females.
snehan ayogya rugnas.
chronic cases of vulvovaginitis. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Study The Guna And Karma Of Yashti Ghruta in detail |
To Study The Efficacy Of Pittaj Yonivyapad With Ayurvedic Samhita And Modern Aspects |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To Study Pittaj Yonivyapad With Ayurvedic Samhitas And Modern Aspect. |
To Compare The Efficacy Of Yashti Ghrut Orally And Locally With Capsule Amoxicillin And Betadine Pessary |
|
|
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)
|
30/07/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
30/07/2025 |
| 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
|
TITLE: Randomized Controlled Clinical Trial To Evaluate The Efficacy Of Yashti Ghrut Paan And Pichu Dharana In Management Of Pittaj Yonivyapad W.S.R to Vulvovaginitis.
OBJECTIVE: To Study The Efficacy Of Yashti Ghrut Orally And Locally In Management Of Pittaj Yonivyapad To Study Guna And Karma Of Yashti Ghrut In Detail To Study Pittaj Yonivyapad With Ayurvedic Samhitas And Modern Aspects. To Compare The Efficacy Of Yashti Ghrut Orally And Locally With Capsule Amoxicillin And Betadine Pessary To Study Etiopathology Of Vulvovaginitis Randomized Comparitive Clinical Study Study Will Be Conducted On 60 Diagnosed Patients Of Pittaj Yonivyapad Written consent will be taken BRIEF SUMMARY: Selected 60 patients Will Be Randomly Distributed in to two equal groups each comprising 30 patients. Groups will be named as Group A and Group B Group A- Yashtimadhu siddha ghruta paan and pichudharan patients in number 30 Group B - Amoxicillin capsules and Betadine pessary patients in number 30 ROUTE OF ADMINISTRATION: Local in the form of pichudharan and pessary oral in the form of snehapan and capsules DURATION: 7 DAYS
Statistical analysis using appropriate statistical test
Discussion. |