| CTRI Number |
CTRI/2021/04/032926 [Registered on: 19/04/2021] Trial Registered Prospectively |
| Last Modified On: |
17/04/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Marham-e-Safedab As A Local Applicator in Anal crack. |
|
Scientific Title of Study
|
A Comparative Study of Marham-e-Safedab with Diltiazem Gel 2% in Shiqaqe Maqad (Anal Fissure). |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Wazeef Akhtar Momin |
| Designation |
Pg Scholar |
| Affiliation |
National Institute Of Unani Medicine |
| Address |
Opd No.07 Department Of Ilmul Jarahat National Institute Of Unani Medicine Kottigepalya Magadi Main Road Bengaluru
Bangalore
KARNATAKA
560091
India |
| Phone |
9769612378 |
| Fax |
|
| Email |
dr.wazeefakhtar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Wazeef Akhtar Momin |
| Designation |
Pg Scholar |
| Affiliation |
National Institute Of Unani Medicine |
| Address |
Opd No.07 Department Of Ilmul Jarahat National Institute Of Unani Medicine Kottigepalya Magadi Main Road Bengaluru
Bangalore
KARNATAKA
560091
India |
| Phone |
9769612378 |
| Fax |
|
| Email |
dr.wazeefakhtar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Firdous Ahmed Najar |
| Designation |
Assistant Professor |
| Affiliation |
National Institute Of Unani Medicine |
| Address |
Opd No.07 Department Of Ilmul Jarahat National Institute Of Unani Medicine Kottigepalya Magadi Main Road Bengaluru
Bangalore
KARNATAKA
560091
India |
| Phone |
7483144988 |
| Fax |
|
| Email |
drfirdous2012@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute Of Unani Medicine |
|
|
Primary Sponsor
|
| Name |
National Institute Of Unani Medicine |
| Address |
Kottigepalya Magadi Main Road Bengaluru Karnataka 560091 |
| 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 |
| Wazeef Akhtar Momin |
National Institute Of Unani Medicine |
Opd No.07 Department Of Ilmul Jarahat National Institute Of Unani Medicine Kottigepalya Magadi Main Road Bengaluru
Bangalore
KARNATAKA |
9769612378
dr.wazeefakhtar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE(IEC) FOR BIOMEDICAL RESEARCH |
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 |
| Comparator Agent |
DILTIAZEM GEL 2% |
patients will be applied Diltiazem Gel 2% locally by tip of the finger twice a day for six weeks |
| Intervention |
MARHAM-E-SAFEDAB |
INGREDIENTS-Mom Safed-1Part
Safeda Kashghari-1Part Murdar sang-1Part Roghan-e-Gul-2Parts,Initially allow mom Safed to dissolve completely in Roghan-e-Gul at very low flame, then add fine powder of Safeda Kashghari and Murdar Sang into it and mix it thoroughly to form ointment, Prepared ointment will be applied locally by tip of the finger over the anal fissure site twice a day for six weeks
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Anterior and /or Posterior Anal Fissure
Acute and/or chronic Anal Fissure |
|
| ExclusionCriteria |
| Details |
Patient with 3rd/4th Degree Haemorrhoids or thrombosed pile mass
Pregnant women
In case of any Malignancy
When associated with severe systemic diseases
Complicated multiple Fissures
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Complete Healing Of Anal Fissure |
42 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Subjective Parameter -Evaluation Of Pain through Visual Analogue
Scale(VAS)
Evaluation of Per Rectal Bleeding & Anal Itching
Through Corrects Scale
Objective Parameter-
Anal Sphincter Tone & Tenderness By Per
Rectal Digital Examination |
6 consecutive weeks |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
23/04/2021 |
| 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
|
Nil |
|
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 & Painful Proctologic disease affecting a Majority
of the population World wide. According to
conventional system of medicine various managements are like Inj. Botulinum
toxin, topical application of Calcium channel blocker (Diltiazem Gel 2%), Local
vasodilators (topical Nitrates) etc. but these drugs have some drawbacks like
local irritation, short duration of action and more systemic absorption side
effects etc. When conservative treatment fails for more than 6 week then
surgical treatment is required like Lord,s
Dilation, Fissurectomy or Internal sphincterotomy but these are also
having different complications like hemorrhage, Hematoma ,Perianal abscess and
incontinence of stools. In view of common prevalence, drawbacks and non-
availability of affordable and safe treatment of anal fissures, the present
comparative study is being designed to manage the anal fissures and
Evaluate a Unani formulation viz Marham -e-Safedab as Topical Ointment
Applicator with main objective to find out a convenient, non- operative, painless,
safe, affordable, efficient remedy with comparison to the Calcium channel
blocker (Diltiazem Gel 2%). |