| CTRI Number |
CTRI/2022/01/039555 [Registered on: 19/01/2022] Trial Registered Prospectively |
| Last Modified On: |
18/01/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
EFFECT OF TANKAN JAL YONIDHAVAN ON CERVICAL Ulceration. |
|
Scientific Title of Study
|
OPEN RANDOMISED CONTROLLED CLINICAL STUDY ON EFFICACY OF
TANKAN JAL YONIDHAVAN ON GARBHASHAY GRIVAGAT VRANA WITH
SPECIAL REFRENCE TO CERVICAL EROSION. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Snehal Balasaheb Sonawane |
| Designation |
PG Scholar Prasutitantra evum Striroga |
| Affiliation |
Hon Shri Annasaheb Dange Ayurvedic Medical College And Post Graduate Research Centre Ashta |
| Address |
Hon Shri Annasaheb Dange Ayurved Medical College ,Ashta ,tal-Walava,Dist-sangali
Sangli
MAHARASHTRA
416301
India |
| Phone |
9420701328 |
| Fax |
|
| Email |
sonawanesneh96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vd Tinku Ganesh Khalache |
| Designation |
Associate Professor |
| Affiliation |
Hon Shri Annasaheb Dange Ayurvedic Medical College And Post Graduate Research Centre Ashta |
| Address |
Department of Prasutitantra evam Strirog Hon Shri Annasaheb Dange Ayurved Medical College ,Ashta ,tal-Walava,Dist-sangali
Department of Prasutitantra evam Strirog Hon Shri Annasaheb Dange Ayurved Medical College ,Ashta ,tal-Walava,Dist-sangali
Sangli
MAHARASHTRA
416301
India |
| Phone |
9423041730 |
| Fax |
|
| Email |
tinkuganeshkhalache@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Snehal Balasaheb Sonawane |
| Designation |
PG Scholar Prasutitantra evum Striroga |
| Affiliation |
Hon Shri Annasaheb Dange Ayurvedic Medical College And Post Graduate Research Centre Ashta |
| Address |
Hon Shri Annasaheb Dange Ayurved Medical College ,Ashta ,tal-Walava,Dist-sangali
Sangli
MAHARASHTRA
416301
India |
| Phone |
9420701328 |
| Fax |
|
| Email |
sonawanesneh96@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dhanvantari Hospital, Ashta,Tal-Walva,Dist -Sangli |
|
|
Primary Sponsor
|
| Name |
Hon Shri Annasaheb Dange Ayurved Medical College Ashta talWalavaDistsangali |
| Address |
Hon Shri Annasaheb Dange Ayurved Medical College ,Ashta ,tal-Walava,Dist-sangali |
| 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 |
| Snehal Balasaheb Sonawane |
Dhanwantari Hospital ,Ashta, |
Department of prasutitantra evum stri roga ,opd no 6,Hon Shri Annasaheb Dange Ayurved Medical College ,Ashta ,tal-Walava,Dist-sangali
Sangli
MAHARASHTRA |
9420701328
sonawanesneh96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N00-N99||Diseases of the genitourinary system. Ayurveda Condition: Garbhashaya Grivagata Vrana, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
TANKAN JAL Yonidhavan on Garbhashaya grivagata vrana. |
Group A of 40 patients having garabhashaya grivagata vrana will treat with Tankan jal Yonidhavan.Duration of treatment of 10 days at morning after stool passed. |
| Comparator Agent |
Triphala kwath yonidhavan on garbhashaya grivagata vrana. |
Group B of 40 patients having garbhashaya grivagata vrana will treat with triphala kwath yonidhavan.Duration of treatment is 10 days at morning after stool passed. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
1)Married Woman. 2)Clinically diagnosed patients of garbhashaya grivagata vrana having symptoms of -Yonigata strav,Yonikandu ,Yonishool,katishool,ulceration of cervix. |
|
| ExclusionCriteria |
| Details |
1)Unmarried and pregnant woman.
2)cervical polyp
3)cervical cancer
4)PID
5)Other systemic disease like HTN,DM,TB,Thyroid Dysfunction,STD etc |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To study effects of Tankan jal yonidhavanon symptoms like yonigatastrav, yonikandu,yonishool,cervical tenderness, ulceration of cervix in Treatment of 10days yonidhavan. |
10 days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To review literature of Garbhashaya grivagata vrana with special reference to cervical erosion |
4 weeks |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
25/01/2022 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study attempt to evaluate the efficacy of tankan jal yonidhavan on garbhahaya grivagata vrana with special reference to cervical erosion. This study attempt to evaluate untoward effect of Tankal jal yonidhavan in cervical erosion. As there is no previous work done on this topic so emphasis will be made to find out easy, cost effective method to control cervical erosion with no side effects. |