| CTRI Number |
CTRI/2025/04/084164 [Registered on: 04/04/2025] Trial Registered Prospectively |
| Last Modified On: |
03/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study effect of Yavadi Varti and mashadi Varti for management of Vulvo vaginal candidiasis |
|
Scientific Title of Study
|
A comparative clinical study of Yavadi Varti and Mashadi Varti in the management of Kaphaja Yonivyapada w.s.r to Vulvo vaginal 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 |
ROHIT TIWARI |
| Designation |
P.G. Scholar |
| Affiliation |
Mansarovar Ayurvedic Medical College Hospital and Research Center |
| Address |
Department of Prasuti Tantra Evum Stri Roga third floor room number 1, Mansarovar Ayurvedic Medical College Hospital and Research Center Hinotiya Alam, Kolar road, Bhopal
Bhopal
MADHYA PRADESH
462042
India |
| Phone |
8839274347 |
| Fax |
|
| Email |
rohittiwari9161@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manish Sahu |
| Designation |
Associate professor |
| Affiliation |
Mansarovar Ayurvedic Medical College Hospital and Research Center |
| Address |
Department of Prasuti Tantra Evum Stri Roga third floor room number 1, Mansarovar Ayurvedic Medical College Hospital and Research Center Hinotiya Alam, Kolar road, Bhopal
Bhopal
MADHYA PRADESH
462042
India |
| Phone |
9893002474 |
| Fax |
|
| Email |
dr.manishsahu1984@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ROHIT TIWARI |
| Designation |
P.G. Scholar |
| Affiliation |
Mansarovar Ayurvedic Medical College Hospital and Research Center |
| Address |
Department of Prasuti Tantra Evum Stri Roga third floor room number 1, Mansarovar Ayurvedic Medical College Hospital and Research Center Hinotiya Alam, Kolar road, Bhopal
Bhopal
MADHYA PRADESH
462042
India |
| Phone |
8839274347 |
| Fax |
|
| Email |
rohittiwari9161@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mansarovar Ayurvedic Medical College Hospital and Research Center, Hinotiya Alam, Kolar Road, Bhopal, 462042 |
|
|
Primary Sponsor
|
| Name |
Mansarovar Ayurvedic Medical College Hospital and Research Center |
| Address |
Department of Prasuti Tantra Evum Stri Roga third floor room number 1, Mansarovar Ayurvedic Medical College Hospital and Research Center Hinotiya Alam, Kolar road, Bhopal, 462042 |
| 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 ROHIT TIWARI |
Mansarovar Ayurvedic Medical College Hospital And Research Center |
Department of Prasuti Tantra Evum Striroga Third floor, Hinotiya Alam, Kolar Road, Bhopal, 462042
Bhopal
MADHYA PRADESH |
8839274347
rohittiwari9161@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Mansarovar Ayurvedic Medical College Hospital and Research Center Bhopal |
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, (2) ICD-10 Condition: N768||Other specified inflammation of vagina and vulva, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | yoni varti, योनि वर्ति | (Procedure Reference: charak chikitsa 30/70, Procedure details: Pradhan karma- Prepared varti is inserted in vagina.
Pashchat karma- Ushna Jal Prakshalan)
(1) Medicine Name: Yavadi Varti, Reference: charak chikitsa 30/71, Route: Vaginal, Dosage Form: Varti/ Suppository, Dose: 500(mg), Frequency: od, Duration: 7 Days | | 2 | Comparator Arm | Procedure | - | yoni varti, योनि वर्ति | (Procedure Reference: Ashtang sangraha uttar tantra 39/64, Procedure details: Pradhan karma- Prepared varti is inserted in vagina.
Pashchat karma- Ushna Jal Prakshalan)
(1) Medicine Name: Mashadi varti, Reference: Ashtang sangraha uttar tantra 39/65, Route: Vaginal, Dosage Form: Varti/ Suppository, Dose: 500(mg), Frequency: od, Duration: 7 Days |
|
| Comparator Agent |
MASHADI VARTI |
30 patient will be selected for yoni varti by mashadi varti 1 time in a day for 45minutes for 7 days in ritu kala and ushnajala prakshalana as prashchata karma |
| Intervention |
Yavadi Varti |
30 patient will be selected for yoni varti by yavadi varti 1 time in a day for 45minutes for 7 days in ritu kala and ushnajala prakshalana as prashchata karma |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Patient having classical symptoms of Kaphaja Yonivyapada as per the classical references will be selected |
|
| ExclusionCriteria |
| Details |
Patients below the age of 18 and above 45 years, pregnant and lactating women, patient suffering from bacterial vaginosis, trichomoniasis vaginitis, atrophic vaginitis, non-infectious vaginitis, viral vaginitis, during menstrual cycle, cervical erosion, cervical ectopy are excluded |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the effect of Yavadi Varti and Mashadi Varti in Kaphaja Yonivyapada |
3 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study Kaphaja Yonivyapada & Vulvovaginal Candidiasis & to study mode of action of Yavadi Varti & Mashadi Varti |
3 Weeks |
|
|
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)
|
05/05/2025 |
| 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="0"
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
|
Total 60 patient will be randomly selected and divided into 2 group 1 group will be treated with Yavadi Varti, 2nd group will be treated with Mashadi Varti, there will be evaluation and comparision of the effect on Kaphaja Yonivyapada w.s.r to Vulvo vaginal candidiasis |