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CTRI Number  CTRI/2024/07/070524 [Registered on: 12/07/2024] Trial Registered Prospectively
Last Modified On: 10/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Unani
Surgical/Anesthesia 
Study Design  Other 
Public Title of Study   A comparative study to evaluate the efficacy of drug marham-e-hindi versus lateral internal sphincterotomy in treatment of shiqaq-ul- maqad(Anal fissure) 
Scientific Title of Study   EFFICACY OF MARHAM-E-HINDI VERSUS LATERAL INTERNAL SPHINCTEROTOMY IN TREATMENT OF SHIQAQ-UL- MAQAD(ANAL FISSURE) 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rameez Raja Mallah 
Designation  PG Scholar 
Affiliation  National Institute of Unani Medicine 
Address  National Institute of Unani Medicine, Kottigepalya, Magadi Main Road, Bangalore KARNATAKA 560091 India
Departmet of Ilmul Jarahat,OPD 07 National Institute of Unani Medicine, Kottigepalya, Magadi Main Road, Bangalore KARNATAKA 560091 India
Bangalore
KARNATAKA
560091
India 
Phone  8825034608  
Fax    
Email  drrehanrameez@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Mohammed Shakeel Ansari 
Designation  Associate Professor dept of ilmul jarahat 
Affiliation  National Institute of Unani Medicine 
Address  National Institute of Unani Medicine, Kottigepalya, Magadi Main Road Bangalore KARNATAKA 560091 India
Department of Ilmul Jarahat, OPD 07 National Institute of Unani Medicine, Kottigepalya, Magadi Main Road, Bangalore KARNATAKA 560091 India
Bangalore
KARNATAKA
560091
India 
Phone  7411219599  
Fax    
Email  msnium@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr. Mohammed Shakeel Ansari 
Designation  Associate Professor dept of ilmul jarahat 
Affiliation  National Institute of Unani Medicine 
Address  National Institute of Unani Medicine, Kottigepalya, Magadi Main Road, Bangalore KARNATAKA 560091 India
Department of Ilmul Jarahat OPD 07 National Institute of Unani Medicine, Kottigepalya, Magadi Main Road, Banglore KARNATAKA 560091 India
Bangalore
KARNATAKA
560091
India 
Phone  7411219599  
Fax    
Email  msnium@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Unani Medicine Kottigepalya Magadi Main Road Bengaluru 560091 karnataka India 
 
Primary Sponsor  
Name  National Institute of Unani Medicine 
Address  National Institute of Unani Medicine, Kottigepalya, Magadi Main Road, Bangalore 560091  
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rameez Raja Mallah  National Institute of Unani Medicine  Department of Ilmul Jarahat, OPD no.7, Kottigepalya, Magadi Main Road, Bangalore 560091 Bangalore KARNATAKA
Bangalore
KARNATAKA 		 8825034608

drrehanrameez@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Communication of Decision of the institutional ethics committe (IEC) for Biomedical research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K90-K95||Other diseases of the digestive system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Lateral internal sphincterotomy  This procedure will be done accordingly 
Intervention  Marham e Hindi  Marham will be applied locally twice a day for one month  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Anal Fissure.
Patients of all genders.
Age 18-60 years.
Patients must be able and willing to provide written informed consent and comply
with the requirements of this study protocol. 
 
ExclusionCriteria 
Details  Fissures associated with the third and fourth-degree or thrombosed piles
Malignancy
Multiple fissures.
Pregnant and lactating mothers.
Patients with Systemic disease 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Healing of Anal fissure, Tenderness on Digital Per Rectal Examination, anal sphincter spasm.  AT 7th,14th,21th and after 30th day 
 
Secondary Outcome  
Outcome  TimePoints 
Healing of Anal Fissure  Within one Month 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   22/07/2024 
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 Yet Recruiting 
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   An anal fissure is a tear in the mucous membrane of the anal canal.. Anal fissures are most common in young adults. It is more common in women than in men. Fissure in ano is caused by a combination of internal anal sphincter hypertonicity and ischemia in the posterior midline region of the anal canal as a consequence of constipation. Anal Fissure treatment includes discomfort spasm and ischemia suppression. Medical sphincterotomy involves the use of a topical ointment containing a calcium channel blocker such as diltiazem. A common recommendation is to treat anal fissures conservatively rather than surgically.. According to the 2014 American College of Gastroenterology clinical recommendation on the management of benign anorectal diseases, acute anal fissures should be managed nonoperatively in the initial phase.. Acute fissures could lead to severe recurrent pain after defecation, although chronic fissures often cause less pain. The typical history of discomfort, bleeding, discharge, and clinical findings assist in diagnosing it., In the Unani System of Medicine, Shiqaq-ulMiqad (fissure in Ano) is a very common and painful condition9. Atibba states that Shiqaqul-Maqad is a breach in the anal mucosa due to Ghalbae Yaboosat and Hararat. The fecal matter becomes dry and hard during defecation it disrupts the anal mucosa. It may also be due to haemorrhoids, tortuosity of rectal vessels, proctitis, Ishaal and Warme Miqad Haar, Saudavi or Reehi,. The patient complains of intense, sharp, biting, and burning pain in the perineum. There are two types of Anal fissures: acute and chronic. Acute fissures present with a tag of hypertrophied skin called a sentinel pile and a hypertrophied papilla with a canoe-shaped ulcer in between.. Acute fissures normally heal with conservative treatment which involves analgesics, stool softeners, local anesthetic agents, a high fiber diet, and plenty of oral fluids. . Surgical intervention such as lord’s dilatation of the anal canal and lateral sphincterotomy should be performed in chronic fissures and if conservative treatment fails in acute fissures.   
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