| CTRI Number |
CTRI/2025/03/082324 [Registered on: 17/03/2025] Trial Registered Prospectively |
| Last Modified On: |
12/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
comparison of diltiazem gel therapy and surgical intervention in treatment of chronic fissure in ano |
|
Scientific Title of Study
|
A comparative study of topical 2 percent of Diltiazem gel versus lateral internal sphincterotomy in the treatment chronic fissure in Ano in a tertiary care centre in Nagpur a randomized control trial |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Divish Saxena |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences Nagpur |
| Address |
Room no 202 ,OPD building Department of general surgery, All India Institute of Medical Sciences, MIHAN, Dahegaon, Nagpur
Nagpur
MAHARASHTRA
441108
India |
| Phone |
7066501626 |
| Fax |
|
| Email |
drdivishsaxena@aiimsnagpur.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tippanna Talwar |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences Nagpur |
| Address |
Room no 202 ,OPD building Department of general surgery, All India Institute of Medical Sciences, MIHAN, Dahegaon, Nagpur
Nagpur
MAHARASHTRA
441108
India |
| Phone |
9513025029 |
| Fax |
|
| Email |
tippannatalawar50@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tippanna Talwar |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences Nagpur |
| Address |
Room no 202 ,OPD building Department of general surgery, All India Institute of Medical Sciences, MIHAN, Dahegaon, Nagpur
MAHARASHTRA
441108
India |
| Phone |
9513025029 |
| Fax |
|
| Email |
tippannatalawar50@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Dahegaon, MIHAN, Nagpur, Maharashtra, 441108
|
|
|
Primary Sponsor
|
| Name |
Dr. Tippanna Talwar |
| Address |
Room no 202, OPD building, Department of General Surgery, All India Institute of Medical Sciences, Dahegaon, MIHAN, Nagpur, Maharashtra, 441108
|
| Type of Sponsor |
Other [Self] |
|
|
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 Tippanna Talwar |
All India Institute of Medical Sciences Nagpur |
Room no 202, OPD building, Department of General Surgery, All India Institute of Medical Sciences, Dahegaon, MIHAN
Nagpur
MAHARASHTRA |
9513025029
tippannatalawar50@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Department of Pharmacology, AIIMS Nagpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K601||Chronic anal fissure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
2 percent diltiazem gel |
One group will be intervened by 2 percent diltiazem gel Patient will be advised to apply the gel into the anus at least one and half cm. before and after defecation for six consecutive weeks. Patient will be followed up on first ,fourth and sixth weeks on OPD basis |
| Comparator Agent |
Lateral internal sphincterotomy |
After standardized pre-op preparations, the other group will be taken up for surgery The patients will be followed up on first fourth and sixth weeks on OPD basis |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Clinically diagnosed as case of Chronic Fissure in Ano
Patients between 18 to 60 years of age of either gender
|
|
| ExclusionCriteria |
| Details |
Childrens and mentally handicapped patients.
Recurrent fissures.
Fissures along with hemorrhoids or /and fistula
Fissures associated with malignancies ,other comorbidities condition like diabetes mellitus, hypertension etc .
Fissures secondary to specific diseases like
tuberculosis, Crohn’s disease ,PLHIV, etc
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain relief will be assessed using Visual Analogue Scale on post intervention 1, 4 and 6 week |
1, 4 and 6 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in Anal tone pressure will be assessed by Sphinctometer on 1,4,and 6 weeks |
1, 4 and 6 weeks |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
23/03/2025 |
| 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
|
All clinically diagnosed cases of chronic fissure in ano will be divided into two groups. Group 1 patients will be treated with 2% Diltiazem gel. Group 2 patients will be treated with lateral internal sphincterotomy. Both groups will be followed up on 1st, 4th and 6th week on OPD basis to assess the outcomes as listed above. The rationale is to explore the role of topical 2% diltiazem as effective and safe alternative to lateral internal sphicterotomy for treatment of chronic fissure in ano. |