| CTRI Number |
CTRI/2024/08/072002 [Registered on: 06/08/2024] Trial Registered Prospectively |
| Last Modified On: |
05/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Comparison study to evaluate the efficacy and safety of a topical gel |
|
Scientific Title of Study
|
A comparative study to evaluate the efficacy and safety of Diltiazem hydrochloride 2 percent w/w plus Lidocaine hydrochloride 2 percent w/w Gel with Lignocaine Hydrochloride Gel 2 percent w/w in anal fissure patients A
Prospective Randomized Open-Label Single Centre Comparative Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| AMD/P/24/001 Version 1 Dated 31052024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jaya Maheshwari |
| Designation |
Director |
| Affiliation |
Jyoti Nursing Home |
| Address |
Room number 1 ground floor Jyoti Nursing Home Vkia Road no 4 Jaipur Rajasthan India
Jaipur
RAJASTHAN
302023
India |
| Phone |
9892145501 |
| Fax |
|
| Email |
cheemoli@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jaya Maheshwari |
| Designation |
Director |
| Affiliation |
Jyoti Nursing Home |
| Address |
Room number 1 ground floor Jyoti Nursing Home Vkia Road no 4 Jaipur Rajasthan India
Jaipur
RAJASTHAN
302023
India |
| Phone |
9892145501 |
| Fax |
|
| Email |
cheemoli@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Jawahar Nidamboor |
| Designation |
Assistant Vice President |
| Affiliation |
Alpha MD Pvt Ltd |
| Address |
Cabin 1 Ground floor 21 Unique Ind Estate VS Marg Prabhadevi Mumbai Maharashtra 400025
Mumbai
MAHARASHTRA
400025
India |
| Phone |
9167254879 |
| Fax |
|
| Email |
jawahar.nidamboor@alphamd.com |
|
|
Source of Monetary or Material Support
|
| Abbott India Limited Floor 16 Godrej BKC Plot No C 68 BKC Near MCA Club Bandra (E)
Mumbai 400 051 |
|
|
Primary Sponsor
|
| Name |
Abbott India Limited |
| Address |
Abbott India Limited Floor 16 Godrej BKC Plot No C 68 BKC Near MCA Club Bandra (E)
Mumbai 400 051 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Jaya Maheshwari |
Jyoti Nursing Home |
Room number 1 ground floor Jyoti Nursing Home Vkia Road no 4 Jaipur Rajasthan India
Jaipur
RAJASTHAN |
9892145501
cheemoli@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Indira IVF Hospital pvt ltd |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K602||Anal fissure, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
CremaGel-L contains
Diltiazem hydrochloride 2% w/w + Lidocaine hydrochloride 2% w/w Gel |
The test product has to applied thrice a day topically around the inner sides of the anal canal for 21 days |
| Comparator Agent |
Lignocaine Hydrochloride Gel 2% w/w |
The reference product has to applied thrice a day topically around the inner sides of the anal canal for 21 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
64.00 Year(s) |
| Gender |
Both |
| Details |
Males and females with age 18 to 64 years (both inclusive) with a diagnosis of anal fissure
Willing to stop all other concomitant topical preparations applied peri-anally prior to commencing study treatment and throughout the study
Subjects who understand the requirement of the study and is willing to sign and date written informed consent to participate in the study |
|
| ExclusionCriteria |
| Details |
Subjects unwilling to have an examination of anal fissure
Subjects having anal fistulas or anal fissure of various causes such as Crohn disease anal suppuration abscesses
Subjects who have or have undergone the following gastrointestinal disorders or procedures Inflammatory bowel disease chronic fecal
incontinence anal abscess a history of radiation therapy to the pelvis fixed anal stenosis/fibrosis
Subjects with a history of neoplastic disease within 5 years
Subjects with associated acute hemorrhoidal attacks
Subjects having anal or perianal cancer
Subjects who have had lateral sphincterotomy or anal stretch or other previous surgery involving the anal canal or perianal region
Subjects with a clinically significant history of renal hepatic neurological dermatological immunological major psychiatric (including drug or alcohol abusers) or hematological illness
Subjects of hypertension / ischemic heart disease on oral calcium channel blockers
Subjects with atrial fibrillation associated with other conditions
Subjects with cardiovascular disease
Subjects who have previously received therapy with diltiazem hydrochloride cream nitrates vasodilator or other topical calcium channel blockers
Subjects with hypersensitivity to any of the ingredients in the study drug
Females of childbearing potential must have a negative pregnancy test and be non-lactating
Subjects who are unsuitable for any other reason to participate in the study in the opinion of the investigator
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of Diltiazem hydrochloride 2% w/w +Lidocaine hydrochloride 2% w/w Gel with Lignocaine Hydrochloride Gel 2% w/w |
Baseline Day 10 Day 21 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the change in Mean Resting Anal Pressure of Anal Fissure
Patients after applying Diltiazem hydrochloride 2% w/w + Lidocaine
hydrochloride 2% w/w Gel with Lignocaine Hydrochloride Gel 2%
w/w at 30 minutes on Day 1 and at Day 10 and Day 21 with baseline
To evaluate the tolerability and safety of Diltiazem hydrochloride 2%
w/w + Lidocaine hydrochloride 2% w/w Gel with Lignocaine
Hydrochloride Gel 2% w/w during the study period |
Day 1 Day 10 and Day 21 with baseline |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
22/08/2024 |
| Date of Study Completion (India) |
28/12/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Anal fissure is a superficial tear in the anoderm distal to the dentate line.
Anal fissures are common in those with a history of constipation or hard
stools, low fibre diet, trauma, and previous anal surgery. It has been
postulated that, lidocaine can provide additional benefits if added to anal
dilators like diltiazem, nifedipine, GTN and minoxidil for the treatment of
anal fissures. Although, there is data generated for the efficacy and safety
of the Diltiazem hydrochloride 2% w/w + Lidocaine hydrochloride 2%
w/w Gel with Lignocaine Hydrochloride Gel 2% w/w individually in anal
fissure patients. However, it has not been compared with each other. Also,
the change in mean anal resting pressure, which is the primary treatment
goal in anal fissure management, after the use of the FDC has not been
established. Due to the lack of this data, it is essential to understand the
efficacy of the Diltiazem hydrochloride 2% w/w + Lidocaine
hydrochloride 2% w/w Gel with Lignocaine Hydrochloride Gel 2% w/w |