| CTRI Number |
CTRI/2022/01/039382 [Registered on: 13/01/2022] Trial Registered Prospectively |
| Last Modified On: |
12/01/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
AYURVEDIC MANAGMENT OF CERVICAL EROSION WITH YASTIMADHU GRITA TAMPOON |
|
Scientific Title of Study
|
A RANDOMIZED CLINICAL STUDY TO EVALUTE THE EFFICACY OF YASTIMADHU GRITA IN THE MANAGEMENT OF CERVICAL EROSION |
| Trial Acronym |
A RANDOMIZED CLINICAL STUDY TO EVALUATE THE EFFICACY OF YASTIMADHU GHRITA IN THE MANAGEMENT OF CERVICAL EROSION |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr SILPA VS |
| Designation |
PG SCHOLAR |
| Affiliation |
SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH HOSPITAL BENGALURU |
| Address |
SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH HOSPITAL 21ST KM KANAKAPURA ROAD UDAYAPURA POST BENGALURU KARNATAKA
SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH HOSPITAL 21ST KM KANAKAPURA ROAD UDAYAPURA POST BENGALURU KARNATAKA
Bangalore
KARNATAKA
560082
India |
| Phone |
9400722412 |
| Fax |
|
| Email |
drsilpa1018@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrSavita SPatil |
| Designation |
Professor and HOD |
| Affiliation |
SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH HOSPITAL BENGALURU |
| Address |
SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH HOSPITAL 21ST KM KANAKAPURA ROAD UDAYAPURA POST BENGALURU KARNATAKA
SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH HOSPITAL 21ST KM KANAKAPURA ROAD UDAYAPURA POST BENGALURU KARNATAKA
Bangalore
KARNATAKA
560082
India |
| Phone |
9742193553 |
| Fax |
|
| Email |
rampursspatil@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr SILPA VS |
| Designation |
PG SCHOLAR |
| Affiliation |
SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH HOSPITAL BENGALURU |
| Address |
SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH HOSPITAL 21ST KM KANAKAPURA ROAD UDAYAPURA POST BENGALURU KARNATAKA
SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH HOSPITAL 21ST KM KANAKAPURA ROAD UDAYAPURA POST BENGALURU KARNATAKA
Bangalore
KARNATAKA
560082
India |
| Phone |
9400722412 |
| Fax |
|
| Email |
drsilpa1018@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH HOSPITAL,BENGALURU -560082 |
|
|
Primary Sponsor
|
| Name |
SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH HOSPITAL |
| Address |
SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH HOSPITAL 21ST KM KANAKAPURA ROAD UDAYAPURA POST BENGALURU -560082 |
| 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 |
| DrSavita s patil |
SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH HOSPITAL |
DEPARTMENT OF PRASUTI TANTRA AND STREE ROGA , OPD NO 1O ,SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH HOSPITAL21ST KM KANAKAPURA ROAD UDAYAPURA POST BENGALURU -560082
Bangalore
KARNATAKA |
9742193553
rampursspatil@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH HOSPITAL,BENGALURU -56008 |
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: vrana, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
KAMPILLAKADI GRITA PICHU |
NIMBA PATRA PRAKSHALANA followed by KAMPILLAKADI GHRITA YONIPICHU ( Frequency - once daily for 3 hours OR next next urge for urine )( Route of administration - Pervaginal) (Duration -7 days ) |
| Intervention |
YASHTIMADHU GRITA |
NIMBA PATRA PRAKSHALANA(Luke warm) FOLLOWED BY YASTIMADHU GRITA YONI PICHU( frequency -once daily for 3hoursor next urge for urine )( Route of administration -per vaginal) (Duration - for 7days ) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
SUBJECT AGED BETWEEN 18 TO 50 YEARS
SUBJECT WHO FULLFILL THE DIAGNOSTIC CRITERIA OF CERVICAL EROSION .
SUBJECT WHO ARE SEXUALLY ACTIVE
SUBJECT HAVING CONTACT BLEEDING
SUBJECT HAVING CERVICAL EROSION WITH CERVICITIS |
|
| ExclusionCriteria |
| Details |
- SUBJECT WITH ACUTE AND CHRONIC PID .
-SUBJECT WHO ARE PREGNANT
- SUBJECT HAVING CERVICAL POLYPS
- SUBJECT SUFFERING FROM CARCINOMA OF CERVIX
-SUBJECT WITH SEVERE SYSTEMIC ---ILLNESS,UNCONTROLLED DIABETES MELLITUS
STD LIKE SYPHILIS AND HIV |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| HEALTHY CERVIX WITHOUT CERVICAL EROSION |
7 DAYS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| REDUCTION IN VAGINAL DISCHARGE, BACK ACHE,ITCHING, |
7 DAYS |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 3 |
|
Date of First Enrollment (India)
|
20/01/2022 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NILL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
cervical erosion is condition where the squamous epithelium of the cervix is replaced by columnar epithelium which continues with the endocervix . it is inter play between two epithelia may be caused by trauma , inflammation or by carcinoma the common symptoms are post coital bleeding , vaginal discharge ( mucopurulent or excessively mucoid ) may have an odor if vaginal infection is is present . if it is associated with cervicitis, it may produice backache , pelvic pain and at times infertility per speculum examination reveals an area of cervix thet look raw, red, and inflammed . in this study clinical evaluation of cervical erosion with yasthimadhu ghrita will be studied , thus establishment of its vranaropaka and shodhaka properties
This work would , thus , be a contribution to find a sure shot treatment for cervical erosion , with a single drug yastimadhu ghrita in pichu |