| CTRI Number |
CTRI/2022/11/047036 [Registered on: 04/11/2022] Trial Registered Prospectively |
| Last Modified On: |
07/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To Observe How Many Patient Of Cervical Erosion Get Symptomatic Relief With Cryotherapy |
|
Scientific Title of Study
|
Cryotherapy As A Mode Of Treatment In Cervical Erosion: An Observational Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shobha Mukherjee |
| Designation |
Professor |
| Affiliation |
Rohilkhand Medical College, Bareilly,UP |
| Address |
Room No. 2028
Department of Obstetrics and Gynecology,
Rohilkhand Medical College, Bareilly,UP
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
9319854442 |
| Fax |
|
| Email |
shosa1974@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shobha Mukherjee |
| Designation |
Professor |
| Affiliation |
Rohilkhand Medical College, Bareilly,UP |
| Address |
Room No. 2028
Department of Obstetrics and Gynecology,
Rohilkhand Medical College, Bareilly,UP
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
9319854442 |
| Fax |
|
| Email |
shosa1974@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shivani Bedi |
| Designation |
Junior Resident |
| Affiliation |
Rohilkhand Medical College, Bareilly,UP |
| Address |
Room No. 2028
First floor
Department of Obstetrics and Gynecology,
Rohilkhand Medical College, Bareilly,UP
Room no 55
PG girls hostel
Rohilkhand Medical College, Bareilly,UP
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
8800558575 |
| Fax |
|
| Email |
shivanibedij5@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rohilkhand Medical College and Hospital , Pilibhit bypass road , Bareilly, UP-243006 |
|
|
Primary Sponsor
|
| Name |
Rohilkhand Medical College and Hospital |
| Address |
Rohilkhand Medical College and Hospital , Pilbhit bypass road , Bareilly, UP-243006 |
| 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 Shobha Mukherjee |
OPD - Obstetrics and Gynecology, Rohilkhand Medical College, Philibhit Bypass Road,Bareilly |
Obstetrics and Gynecology, Rohilkhand Medical College, Philibhit Bypass Road, Bareilly UP 243006
Bareilly
UTTAR PRADESH |
9319854442
shosa1974@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC RMCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N72||Inflammatory disease of cervix uteri, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1.Women with age between 20 to 40 years
2.Women with Intact uterus
3.Women suffering from any/ more/all of the following Symptoms- Abundant vaginal discharge , pelvic pain, Post coital bleeding, dyspareunia.
|
|
| ExclusionCriteria |
| Details |
1.Pap smear with premalignant and malignant changes
2.Active genital tract infections
3.Women who are virgin or pregnant or lactating or have attained menopause
4.Women with medical history of OR suffering from
hypertension/ diabetes mellitus/ bleeding
disorder/any other immunocompromising disease
5.Women taking Oral contraceptive pills
6.Females with history of cervical Neoplasia or
premalignant cervical lesion (CIN-1 & CIN-2)
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the symptomatic improvement among patients after cryotherapy
|
1)Baseline:07/11/22 to 07/11/23
2) 1 month (4 weeks)
3) 3 months(12 weeks) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
(1) To document any complications of cryotherapy .
(2) To analyze the features associated with success of cryotherapy
|
1)Baseline 07/11/22 to 07/11/23
2) 1 month (4 weeks)
3) 3 months (12 weeks) |
|
|
Target Sample Size
|
Total Sample Size="74"
Sample Size from India="74"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
07/11/2022 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [shivanibedij5@gmail.com].
- For how long will this data be available start date provided 31-03-2025 and end date provided 31-01-2060?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This is an Observational study to assess Cryotherapy as a mode of treatment of cervical erosion. This study will be conducted at Gynecology OPD RMCH, Bareilly, UP over a period of one year. The study will recruit 76 patients of cervical erosion according to the inclusion and exclusion criteria , in whom the effect of cryotherapy will be studied. The primary outcome will be To assess the symptomatic
improvement among patients after cryotherapy and the secondary outcome ) (1)To document any complications of cryotherapy (3) To analyze the features associated with
success of cryotherapy Since,
there are few studies in the state of Uttar Pradesh , with regards
to cryotherapy, we decided to determine
ourselves, whether cryotherapy can be safely and effectively used for resolving
symptoms of cervical erosion in a tertiary care setting. |