| CTRI Number |
CTRI/2024/01/061324 [Registered on: 10/01/2024] Trial Registered Prospectively |
| Last Modified On: |
02/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Clinical Trial To Study The Effect Of V-Guard (Spatika) Vaginal Pessary In The Management Of White Discharge |
|
Scientific Title of Study
|
Open Randomized Controlled Clinical Trial OF V-Guard (Spatika) Vaginal Pessary In Shwetpradara With Special Reference To Candidiasis Albicans |
| 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 Dhanashree Raju Ade |
| Designation |
PG Scholar |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Center Ashta |
| Address |
OPD no 6 Strirog And Prasuti Tantra OPD Ground Floor Dhanvantari Ayurved Hospital Ashta Tal Walwa Dist Sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
8975612332 |
| Fax |
|
| Email |
dhanuade96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tinku Ganesh Khalache |
| Designation |
Professor |
| Affiliation |
Hon Shri Annasaheb Dange Ayueved Medical College Post Graduate Research Center Ashta |
| Address |
3rd Floor Department Of Strirog And Prasuti Tantra Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate Research center Ashta Tal Walwa Dist Sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
9423041730 |
| Fax |
|
| Email |
tinkuganeshkhalache@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tinku Ganesh Khalache |
| Designation |
Professor |
| Affiliation |
Hon Shri Annasaheb Dange Ayueved Medical College Post Graduate Research Center Ashta |
| Address |
3rd Floor Department Of Strirog And Prasuti Tantra Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate Research center Ashta Tal Walwa Dist Sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
9423041730 |
| Fax |
|
| Email |
tinkuganeshkhalache@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate Research Center Ashta |
|
|
Primary Sponsor
|
| Name |
Dr Dhanashree Raju Ade |
| Address |
OPD No 6 Strirog And Prasuti Tantra OPD Ground Floor Dhanvantari Ayurved Hospital Ashta Tal Walwa Dist Sangli |
| 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 Dhanashree Raju Ade |
Hon Shri Annasaheb Dange Ayurved Medical College And Dhanvantari Ayurved Hospital Ashta |
OPD no 6 Strirog And Prasuti Tantra OPD Ground Floor Dhanvantari Ayurved Hospital Ashta Tal Walwa Dist sangli
Sangli
MAHARASHTRA |
8975612332
dhanuade96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate Research Center Ashta Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N889||Noninflammatory disorder of cervixuteri, unspecified. Ayurveda Condition: SOMAROGAH/SVETAPRADARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Clotrimazole Vaginal Pessary | Clotrimazole Vaginal Pessary 100 mg Once a Day At bed Time For 7 days placed at vagina | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: V Guard vaginal perrary, Reference: NA, Route: Vaginal, Dosage Form: Varti/ Suppository, Dose: 200(mg), Frequency: hs, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
1 All married cases between the age of 20-upto the age of menopause complaining of Shwetapradara
2 Patient confimed by KOH test
3 Cases irrespective of Socio economical status, religion, occupation is included
4 Candidiasis albicans with DM
5 Candidiasis albicans with cervical erotion |
|
| ExclusionCriteria |
| Details |
1 Unmarried Female patients
2 Per vaginal white discharge other than candidiasis albicans
cervical or uterine malignancy
pregnant women
3 Cervical polyp |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Evaluate The Efficacy Of V Guard Vaginal Pessary Spatika In Shwetpradara |
4 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To Review The Symptoms Of Shwetpradara From Ayurvedic Literature
To Review The Candidiasis Albicans According To Modern
|
4 Weeks |
|
|
Target Sample Size
|
Total Sample Size="74"
Sample Size from India="74"
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)
|
13/01/2024 |
| 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
|
The Poor Hygiene Of Female Genital Organ Causes Shwetpradara And It is one of the Common Gynaecological Complaint in Gynac OPD Current Study is Randomized Controlled Clinical Trial To Check The Effectiveness Of V Guard (Spatika) Vaginal Pessary In The Management Of Shwetpradara Study Consists Of Two Groups A And B Drugs Group A V Guard (Spatika)Vaginal Pessary 200mg Once a Day At Bed Time Placed In Vagina For 7 Days Group B Clotrimazole Vaginal Pessary 100mg Once a Day At Bed Time Placed In Vagina For 7 Days
|