| CTRI Number |
CTRI/2025/05/087722 [Registered on: 27/05/2025] Trial Registered Prospectively |
| Last Modified On: |
23/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
TO SEE EFFECT OF PATHA CHURNA TABLETS IN FEMALES HAVING YONI KANDU |
|
Scientific Title of Study
|
Randomized controlled clinical trial of patha churna vati in yoni kandu in kaphaj yonivyapad wsr 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 Gauri Vijay Magar |
| Designation |
PG Scholar |
| Affiliation |
Shree saptashrungi ayurved mahavidyalaya |
| Address |
Department of prasuti tantra and strirog
OPD no 4 Ground floor
Shree Saptashrungi ayurved mahavidyalay and hospital nashik
Kamal nagar panchavati nashik
422003
Department of prasuti tantra and strirog
OPD no 4 Ground floor
Shree Saptashrungi ayurved mahavidyalay and hospital nashik
Kamal nagar panchavati nashik
422003
Nashik
MAHARASHTRA
422003
India |
| Phone |
9422230022 |
| Fax |
|
| Email |
gaurimagar1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Varsha Suresh Deshmukh |
| Designation |
Professor |
| Affiliation |
Shree Saptashrungi ayurved mahavidyalay and hospital Kamalnagar Hirawadi Panchavati Nashik |
| Address |
Deshmukh niwas Ramwadi Baijabaichi Chhavani Panchavati Nashik
Deshmukh niwas Ramwadi Baijabaichi Chhavani Panchavati Nashik
Nashik
MAHARASHTRA
422003
India |
| Phone |
9403513983 |
| Fax |
|
| Email |
varshasdeshmukh15@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Varsha Suresh Deshmukh |
| Designation |
Professor |
| Affiliation |
Shree Saptashrungi ayurved mahavidyalay and hospital Kamalnagar Hirawadi Panchavati Nashik |
| Address |
Deshmukh niwas Ramwadi Baijabaichi Chhavani Panchavati Nashik
Deshmukh niwas Ramwadi Baijabaichi Chhavani Panchavati Nashik
Nashik
MAHARASHTRA
422003
India |
| Phone |
9403513983 |
| Fax |
|
| Email |
varshasdeshmukh15@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shree saptashrungi ayurved mahavidyalaya and hospital kamal nagar Panchavati Nashik 422003 |
|
|
Primary Sponsor
|
| Name |
Dr Gauri Vijay Magar |
| Address |
Shree Saptashrungi ayurved mahavidyalaya and hospital kamal nagar Panchavati Nashik 422003
Department of prasuti tantra strirog
OPD no 4 ground floor |
| Type of Sponsor |
Private medical college |
|
|
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 Gauri Vijay Magar |
Shree saptashrungi ayurved mahavidyalay and hospital nashik |
Kamal nagar panchavati nashik 422003 Department of prasuti tantra and strirog OPD no 4 ground floor
Nashik
MAHARASHTRA |
9422230022
gaurimagar1999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Shree Saptashrungi ayurved mahavidyalay and hospital Kamalnagar Hirawadi Panchavati Nashik |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N761||Subacute and chronic vaginitis. Ayurveda Condition: KAPAJA-YONIROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Tab Fluconazole 150 mg | Fluconazole is an azole antifungal. It will be administered once a week for two weeks | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Patha churna, Reference: Dhanvantari nighantu shlok no 71, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Weeks, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Yoni kandu
Yoni strava
Yonigat toda |
|
| ExclusionCriteria |
| Details |
Patients having excessive yoni toda
Pregnant women
Patients previously diagnosed with HIV HBSAG VDRL |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduce symptoms of yoni kandu yoni strava and yonigat toda within 7 days of start of treatment |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| No recurrence of yoni kandu |
21 days |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
10/06/2025 |
| 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="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
|
Randomized controlled clinical trial of Patha churna vati in yoni kandu in kaphaj yonivyapad wsr candidiasis Primary objective To study the efficacy of patha churna vati in yoni kandu in kaphaj yonivyapad in comparison to fluconazole tablets Secondary objective To study yoni kandu wsr to candidiasis To evaluate the efficacy of patha churna vati Patients will be divided in two groups Group A and Group B and will be given patha churna vati and fluconazole respectively for two weeks Clinical assesment will be done on 1 st day 7th day 14th day and 21st day Inclusion criteria is age 20 yrs to 40 yrs Yoni kandu Yoni strava Yonigat toda Exclusion criteria Patients having excessive yoni toda Pregnant women Patients previously diagnosed with HIV HBSAG VDRL Withdrawal criteria The patient who wishes to discontinue and not ready for further participation in study will be discontinued During the study if any complication occurs these patients will be excluded from the study and she will be given management accordingly The patient who did not discontinued follow up for two consecutive visits will be treated as discontinued Patients who are not ready to sign the written informed consent Primary outcome Reduce symptoms yoni kandu yoni strava yonigat toda Secondary outcome No recurrence of yoni kandu All data will be collected from clinical case studies will be presented in the form of graphs charts healing grade Patients will be observed before and after treatment All observed data collected after the final assessment will be subjected to statistical analysis
|