| CTRI Number |
CTRI/2024/06/069513 [Registered on: 26/06/2024] Trial Registered Prospectively |
| Last Modified On: |
24/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Number of cases of Fissure in ano in Bangalore |
|
Scientific Title of Study
|
prevalence of fissure in ano and its risk factors among anorectal case :A cross-Sectional study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ANIL KUMAR |
| Designation |
PG SCHOLAR |
| Affiliation |
NIUM |
| Address |
DEPARTMENT OF ILMUL JARAHAT
NATIONAL INSTITUTE OF UNANI MEDICINE, KOTTIGEPALYA, MAGADI MAIN ROAD,
BENGALURU-91
Bangalore
KARNATAKA
560091
India |
| Phone |
8076888925 |
| Fax |
|
| Email |
anilrajkumar622@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Firdous Ahamd Najar |
| Designation |
Assoc. Prof. and HoD |
| Affiliation |
National Institute of Unani Medicine |
| Address |
DEPARTMENT OF ILMUL JARAHAT
NATIONAL INSTITUTE OF UNANI MEDICINE, KOTTIGEPALYA, MAGADI MAIN ROAD,
BENGALURU-91
DEPARTMENT OF ILMUL JARAHAT
NATIONAL INSTITUTE OF UNANI MEDICINE, KOTTIGEPALYA, MAGADI MAIN ROAD,
BENGALURU-91
Bangalore
KARNATAKA
560091
India |
| Phone |
7483144988 |
| Fax |
|
| Email |
drfirdous2012@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anil Kumar |
| Designation |
P.G Scholar |
| Affiliation |
NATIONAL INSTITUTE OF UNANI MEDICINE, |
| Address |
DEPARTMENT OF ILMUL JARAHAT
NATIONAL INSTITUTE OF UNANI MEDICINE, KOTTIGEPALYA, MAGADI MAIN ROAD,
BENGALURU-91
Bangalore
KARNATAKA
560091
India |
| Phone |
807688925 |
| Fax |
|
| Email |
anilrajkumar622@gmail.com |
|
|
Source of Monetary or Material Support
|
| NATIONAL INSTITUTE OF UNANI MEDICINE, BANGALORE, 560091 |
|
|
Primary Sponsor
|
| Name |
National Institute of Unani Medicine |
| Address |
DEPARTMENT OF ILMUL JARAHAT
NATIONAL INSTITUTE OF UNANI MEDICINE, KOTTIGEPALYA, MAGADI MAIN ROAD,
BENGALURU-91 |
| Type of Sponsor |
Research institution |
|
|
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 Anil Kumar |
National Institute of Unani Medicine |
DEPARTMENT OF ILMUL JARAHAT NATIONAL INSTITUTE OF
UNANI MEDICINE KOTTIGEPALYA MAGADI MAIN ROAD
BENGALURU-91
Bangalore
KARNATAKA |
8076888925
anilrajkumar622@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Biomedical Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K928||Other specified diseases of the digestive system, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Age above 18 years.
Fissure in Ano |
|
| ExclusionCriteria |
| Details |
Patients unwilling to participate.
Patients with cognitive impairment preventing them from providing informed consent. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Presence or absence of fissure in ano |
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Data will be analyzed using appropriate statistical software.
2.Prevalence of anal fissures among anorectal cases will be estimated.
3.Bivariate & Multivariate analyses will be done to identify potential correlates or risk factors. |
18 months |
|
|
Target Sample Size
|
Total Sample Size="570"
Sample Size from India="570"
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)
|
15/07/2024 |
| 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 Applicable |
| 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
|
Fissure-in-ano is one of the most common causes of anal pain. It is a linear tear in the squamous epithelial lining of anal canal distal to dentate line. Fissure-in-ano is of two types - acute and chronic. Acute fissure presents within 3–6 weeks of onset of symptoms. Not much is known about the prevalence of Fissure in Ano. It is a frequent reason for consultation in proctology. The first epidemiological study on anal fissures was carried out in New Mexico using diagnostic coding. It estimated the annual incidence of anal fissures in the general population at 0.11%. The authors of this study estimated that the lifetime risk of suffering from anal fissure is 7.8% Another study carried out in Dakar on the same theme, after analysis of 2061 proctological examinations, reported 12.37% of cases of anal fissure. Some authors believe that its prevalence has regional variation. A study conducted in NIUM Hospital between 2012-2013 showed the prevalence of 15.62% of Fissure in Ano among Ano-Rectal cases. |