| CTRI Number |
CTRI/2025/06/089904 [Registered on: 30/06/2025] Trial Registered Prospectively |
| Last Modified On: |
29/06/2025 |
| 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 study the Efficacy Of Shallakyadi Taila Pichu In The Management Of Vipluta Yonivyapada with especial refference of pruritus vulvae |
|
Scientific Title of Study
|
A Randomized Controlled Clinical Trial To Evaluate Efficacy Of Shallakyadi Taila Pichu And Nystatin Pessary In The Management Of Vipluta Yonivyapad With Special Reference Of Pruritus Vulvae |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
VIJAYLAXMI MAUNSHILAL MAURYA |
| Designation |
2nd year prasuti tantra stree roga PG Scholar |
| Affiliation |
Late Kedari Redekar Ayurvedic Mahavidyalaya |
| Address |
Prasuti Tantra Stree Roga Department of Late Kedari Redekqr Ayurvedic Mahavidyalaya,P-2,MIDC, shendri
road,Gadhinglaj,Kolhapur 416501
Late Kedari Redekar Ayurvedic Mahavidyalaya,Shendri road,Gadhinglaj,kolhapur,416501
Kolhapur
MAHARASHTRA
416501
India |
| Phone |
9082940446 |
| Fax |
|
| Email |
vijaylaxmibams@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sarita Harshal Kamate |
| Designation |
Reader in prasuti tantra and stree roga department in Late Kedari Redekar Ayurvedic Mahavidyalaya |
| Affiliation |
Late Kedari Redekar Ayurvedic Mahavidyalaya |
| Address |
Late Kedari Redekar Ayurvedic Mahavidyalaya, Prasuti Tantra and Stree Roga department,Gadhinglaj,Kolhapur,416501
Late kedari Redekar Ayurvedic Mahavidyalaya,Prasuti Tantra and Stree Roga Department, Gadhinglaj, Kolhapur,416501
Kolhapur
MAHARASHTRA
416501
India |
| Phone |
9881988389 |
| Fax |
|
| Email |
saritakamate9@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sarita Harshal Kamate |
| Designation |
Reader in prasuti tantra and stree roga department in Late Kedari Redekar Ayurvedic Mahavidyalaya |
| Affiliation |
Late Kedari Redekar Ayurvedic Mahavidyalaya |
| Address |
Late kedari Redekar Ayurvedic Mahavidyalaya,Prasuti Tantra and Stree Roga Department Gadhinglaj, Kolhapur 416501
Late kedari Redekar Ayurvedic Mahavidyalaya,Prasuti Tantra and Stree Roga Department Gadhinglaj, Kolhapur 416501
Kolhapur
MAHARASHTRA
416501
India |
| Phone |
9881988389 |
| Fax |
|
| Email |
saritakamate9@gmail.com |
|
|
Source of Monetary or Material Support
|
| Late Kedari Redekar Ayurvedic Mahavidyalaya |
|
|
Primary Sponsor
|
| Name |
Vijaylaxmi Munshilal Maurya |
| Address |
Late Kedari Redekar Ayurvedic Mahavidyalaya,P2 MIDC,Shendri rd.Gadhinglaj, Kolhapur 416501 |
| 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 |
| Vijaylaxmi Munshilal Maurya |
Late Kedari Redekar Dharmalay Rugnalay, Gadhinglaj, Kolhapur |
Late Kedari Redekar Ayurvedic Mahavidyalaya, Prasuti Tantra and Stree Roga Department Gadhinglaj,Kolhapur 416501
Kolhapur
MAHARASHTRA |
9082940446
vijaylaxmibams@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Late Kedari Redekar Ayurvedic Mahavidyalaya Gadhinglaj,Kolhapur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N899||Noninflammatory disorder of vagina, unspecified. Ayurveda Condition: VIPLUTA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Nystatin pessary | Before going to bed,Patient should empty the bladder and wash her hand, then take one pessary and it should be kept in applicator tip, introduced the applicator in vagina then push the pistol in forward direction so that pessary get placed in upper 1/3rd of vagina | | 2 | Intervention Arm | Procedure | - | yoni pichu योिन िपचु | (Procedure Reference: Charak samhita, Procedure details: Patient is asked to empty the bladder,shallakyadi taila is warmed, under all aspeptic measures,Patient should be in lithotomy position. Sterile cotton swab is dipped in warm shallakyadi taila & placed in vagina. It should be kept for 2 hours maximum to avoid infection, and is then removed and discarded by the patient independently.)
(1) Medicine Name: Shallakyadi taila, Reference: Charak samhita chikitsa sthan chapter 30 shloka 108 and 109, Route: Vaginal, Dosage Form: Taila, Dose: 25(ml), Frequency: od, Duration: 15 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Patient having sign and symptoms of vipluta yonivyapada having symtooms like yoni kandu,aatiratipriya, nitya yonivedana,such patient will be randomly selected from prasuti tantra stree roga opd of late kedari redekar ayurvedic hospital |
|
| ExclusionCriteria |
| Details |
unmarried,pregnant and lactational, H/O-DM, Patient associated with Genital TB infection,HIV,HBsAG,VDRL postive, Patient with benign and malignant tumor of buterus and cervix, patient who need surgical intervention in cases like pelvis abscess, Tubo-ovarian mass. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome focuses on the clinical efficacy of Shallakyadi Taila Pichu versus Nystatin pessary in managing Vipluta Yonivyapad, with special reference to pruritus vulvae. It will be assessed based on symptomatic relief (Yonikandu, Yonistrava, Yonivedana, Dyspareunia, Dysuria). Assessment will occur at baseline, during treatment, post-treatment, and follow-ups. |
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
NIL |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
04/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
04/08/2025 |
| 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
|
This study is a randomized controlled clinical trial to study the efficacy of shallakyadi taila pichu dharan in yoni and nystatin pessary per vaginum in the management of vipluta yonivyapada w.s.r to pruritus vulvae. Study will be carried out in opd of prasuti tantra and stree roga department of Late kedari redekar ayurvedic hospital,Gadhinglaj. The observation would be drawn on the basisi of symptoms after treatment given. |