| CTRI Number |
CTRI/2022/04/042081 [Registered on: 22/04/2022] Trial Registered Prospectively |
| Last Modified On: |
06/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Nifedipine ointment with Lidocaine vs. Diltiazem ointment with Lidocaine for treatment of Anal Fissure |
|
Scientific Title of Study
|
To study the impact on quality of life of Nifedipine ointment with Lidocaine vs. Diltiazem ointment with Lidocaine for treatment of Anal Fissure: A double-blind randomized controlled trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Piyush Ranjan |
| Designation |
Additional Professor |
| Affiliation |
AIIMS,Delhi |
| Address |
Department of Surgical Disciplines,
All India Institute of Medical Sciences, New Delhi
South
DELHI
110029
India |
| Phone |
9971035243 |
| Fax |
|
| Email |
drpmishra28@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Piyush Ranjan |
| Designation |
Additional Professor |
| Affiliation |
AIIMS,Delhi |
| Address |
Department of Surgical Disciplines,
All India Institute of Medical Sciences, New Delhi
South
DELHI
110029
India |
| Phone |
9971035243 |
| Fax |
|
| Email |
drpmishra28@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Piyush Ranjan |
| Designation |
Additional Professor |
| Affiliation |
AIIMS,Delhi |
| Address |
Department of Surgical Disciplines,
All India Institute of Medical Sciences, New Delhi
South
DELHI
110029
India |
| Phone |
9971035243 |
| Fax |
|
| Email |
drpmishra28@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Surgical Disciplines, AIIMS, Ansari Nagar, New Delhi-110029 |
|
|
Primary Sponsor
|
| Name |
AIIMS Delhi |
| Address |
All India Institute Of Medical Sciences, Ansari Nagar, New Delhi-110029 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Piyush Mishra |
All India Institute of Medical Sciences, New Delhi |
Department of Surgical Disciplines,
All India Institute of Medical Sciences, New Delhi
9971035243, 01126593360
South
DELHI |
01126593360
drpmishra28@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee AIIMS,Delhi |
Approved |
| Institute Ethics Committee AIIMS,Delhi |
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
|
| Type |
Name |
Details |
| Intervention |
0.3% nifedipine and 2% lidocaine ointment. |
topical medication two times daily for a minimum of 6 weeks. The application will be done by the patient with the tip of their index finger (size of a peanut on a fingertip) to just inside and 1 cm around the anus circumferentially. |
| Comparator Agent |
2% diltiazem and 2% lidocaine ointment |
topical medication two times daily for a minimum of 6 weeks. The application will be done by the patient with the tip of their index finger (size of a peanut on a fingertip) to just inside and 1 cm around the anus circumferentially. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
with a definitive diagnosis of anal fissure |
|
| ExclusionCriteria |
| Details |
1. History of reaction to topical agents.
2. Recurrent anal fissures
3. Associated condition or disease such as severe anaemia, cancer, fistula, abscess, Crohn’s disease, HIV related anal ulcer, tuberculosis ulcer, leukemic ulcer, pregnancy, third and fourth degree haemorrhoids, and Diabetes mellitus
4. History of surgical treatment
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the impact on quality of life using REALISE score of patients with anal fissure comparing Nifedipine ointment with Lidocaine vs. Diltiazem ointment with Lidocaine in a double blind randomized controlled trial |
6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)To assess the complaints of perianal irritation/itching during the course of 6-week therapy.
2)Any adverse events due to systemic absorption of topical drugs.
|
3 weeks and 6 weeks |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
Final Enrollment numbers achieved (Total)= "110"
Final Enrollment numbers achieved (India)="110" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
03/05/2022 |
| Date of Study Completion (India) |
30/11/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
30/11/2023 |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Results are available, and the manuscript is in the process of editing for publication |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Several treatment modalities have been studied for acute and chronic anal fissure, and topical calcium channel blockers (CCB) showed promising results in treatment of anal fissure. Topical Diltiazem and Nifedipine are currently widely used CCBs for anal fissure after multiple studies showing their benefits compared to different agents or modalities. Till date there have been no study to our knowledge comparing the two drugs in a blinded trial, so this prospective randomized study is designed to compare the quality of life of patients with acute or chronic anal fissure before and 6 weeks after the topical treatment with diltiazem or nifedipine ointment |