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CTRI Number  CTRI/2025/01/079740 [Registered on: 29/01/2025] Trial Registered Prospectively
Last Modified On: 25/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Unani
Diagnostic 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Application Of Unani Formulation Over Wound Of Anal Canal And Its Comparative Study With Surgical Procedure  
Scientific Title of Study   Evaluation Of Zaroor E Aelwa Versus Lateral Internal Sphincterotomy OF Shaqaq 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  Dr SADIYA FARHAT 
Designation  PG Scholar 
Affiliation  National Institute Of Unani Medicine Banglore 
Address  Department Of Ilmul Jarahat National Institue Of Unani Medicine Kottigepalya Magadi Main Road Banglore 560091 Karnatka Bangalore Karnataka 560091 India

Bangalore
KARNATAKA
560091
India 
Phone  8329980210  
Fax    
Email  drsadiyashaikh11@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mohammad Shakeel Ansari  
Designation  Associate Professor Ilmul Jarahat 
Affiliation  National Institute Of Unani Medicine Banglore 
Address  Department Of Ilmul Jarahat National Institue Of Unani Medicine Kottigepalya Magadi Main Road Banglore 560091 Karnatka Bangalore Karnataka 560091 India

Bangalore
KARNATAKA
560091
India 
Phone  7411219599  
Fax    
Email  msnium@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Mohammad Shakeel Ansari  
Designation  Associate Professor Ilmul Jarahat 
Affiliation  National Institute Of Unani Medicine Banglore 
Address  Department Of Ilmul Jarahat National Institue Of Unani Medicine Kottigepalya Magadi Main Road Banglore 560091 Karnatka Bangalore 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 Banglore 560091 Karnataka India  
 
Primary Sponsor  
Name  National Institute Of Unani Medicine  
Address  Department Of Ilmul Jarahat National Institute Of Unani Medicine Kottigepalya Magadi Main Road Banglore 560091 Karnataka India  
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 Mohammad Shakeel Ansari  Dr SADIYA FARHAT  National Institute Of Unani Medicine Hospital Kottigepalya Magadi Main Road Bangalore Department Of Il mul Jarahat Opd No 07
Bangalore
KARNATAKA 
8329980210

drsadiyashaikh11@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Communication Of Decision Of The Institutional Ethics Committee (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: K628||Other specified diseases of anus and rectum,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  (LIS) LATERAL INTERNAL SPHINCTEROTOMY  The steps of a lateral internal sphincterotomy (LIS) procedure to treat anal fissures include: Prepare the patient: The patient may be given an enema and the surgical field is prepared with a solution like povidone-iodine or chlorhexidine. Position the patient: The patient is placed in a lithotomy or prone jack-knife position. Anesthetize: The patient is given a local anesthetic or general anesthesia. Inspect the anus: The surgeon uses an anoscope to inspect the anus and locate the fissure. Make an incision: The surgeon makes a small incision in the internal anal sphincter. Identify the sphincter: The surgeon uses a hemostat to identify and isolate the internal sphincter muscle. Cut the sphincter: The surgeon cuts the internal sphincter muscle to the level of the dentate line. Close the wound: The surgeon may close the wound with an absorbable suture.  
Intervention  Zaroor-Aelwa  It Is use a Certain Amount Of It As a Local Application (Zaroore Aelwa)will be applied locally over the fissure site (Anal Region) Twice Daily For 21 days  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Anal Fissure (anterior and posterior)
2.Patients of all genders.
3.Age 18-60 years.
4.Patients must be able and willing to provide written informed consent and comply with the requirements of this study protocol. 
 
ExclusionCriteria 
Details  1.Fissures associated with the third and fourth-degree or thrombosed piles mass.
2.Malignancy.
3.Multiple fissures.
4.Pregnant and lactating mothers.
5.Patients with Systemic disease like uncontrolled diabetes,tuberculosis etc 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Pain During And After Defecation (VAS) 0 – 10 Grades
Per Rectal Bleeding (present or absent)
Healing Of Fissure (Yes/No)
Tenderness On Digital Examination (Yes/No)
Anal Sphincter Spasm (Yes/No)
 
At Baseline 0th 7th Day,14th Day 21th Day And After 1 Month Post Treatment 
 
Secondary Outcome  
Outcome  TimePoints 
1.Healing of fissure (Yes/No).
2.Tenderness on Digital examination (Yes/No).
3.Anal sphincter Spasm (Yes/No). 
At baseline, 7th day,14th day, 21st day, and after 1 month post treatment. 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   01/03/2025 
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  
Introduction & Need of the Study:
It is an ulcer in the longitudinal axis of the lower anal canal. Commonly it occurs in the midline, posteriorly (more common in males), but can also occur in the midline anteriorly (more common in females). Ninety-five per cent of anal fissures in men are posterior; 5% are anterior. Eighty per cent of anal fissures in females are posterior; 20% are anterior. Anterior anal fissure is common in females. It is superficial, small but distressing lesion. Fissure ends above at the dentate line.1 Because of the curvature of the sacrum and rectum, hard faecal matter while passing down causes a tear in the anal valve leading to posterior anal fissure. Anterior anal fissure is common in females due to lack of support to pelvic floor. Hard stool; diarrhoea; increased sphincter tone; local ischaemia; trauma; sexually transmitted diseases. Other causes are haemorrhoidectomy, Crohn’s disease, venereal disease, ulcerative colitis, and tuberculosis.1 Fissure in Ano is the most common painful and troublesome anorectal condition that covers a great majority of the population worldwide.2 It is one of the general pathological diseases and a well-known traditional surgical entity that constitutes 70% of the general surgery OPD.2 The incidence of anal fissure is around 1 in 350 adults Globally.3 It effects more than 10% of patient attending proctology clinics and its incidence is growing day by day due to sedentary lifestyle, low fibrous diet and junk foods etc. In India prevalence of anal fissures among patients with anorectal complaints are around 18%.4 An observational study showed that in Bangalore (Karnataka) out of 416 patients with anorectal ailments 65 (15.62%) patients were suffering from anal fissure.4
It can be classified as acute and chronic.5 Acute anal fissure usually heals with conservative treatment which includes oral analgesics, stool softener, local anaesthetic agents, high fibrous diet, using plenty of fluids6 and warm sit bath.7 In certain group of patients due to lack of adherence to life style and diet modification or due to their occupational need of prolong sitting which hamper the local circulation of blood. fissure in Ano persist of longer duration for which is conventional system of medicine there are other conservative management like injection botulinum toxin, topical application of calcium channel blocker (Diltiazem gel 2%) local vasodilator (topical nitrates)1 etc. are available but these drugs have some drawback like local irritation short duration of action. Side effect and adverse effect may be due to excessive systemic absorption. When conservative treatment fail for more than six weeks then surgical treatment is required like lords dilatation Fissurectomy or internal sphincterotomy but these having certain drawbacks like high cost of treatment, prolong hospital stay usually performed in secondary and tertiary hospital and complication like haemorrhage, haematoma, bruising, and perianal abscess and the most important complication is incontinence of stool of a variable nature and severity which may affect up to 30% of patient.8 In view of common prevalence, drawbacks and non-availability of affordable and safe treatment or anal fissures in conventional system, this study is being designed to manage the anal fissure by local application of zaroor-e-Aelwa. As Aelwa is purported to have healing properties and it does not produce local irritation in deep wounds. By the use of zaroor-e-Aelwa locally as fine powder over wound approximates the edge of the wound.10,30 Zakariya Rhazi mentioned in his book Kitab-ul-Hawi that the use Aelwa as topical application in treatment of fissure in Ano very much beneficial.9Review of Literature:
According to Unani system of medicine anal fissure is known as Shiqa ̄q-ul-Maq‘ad 11 which occurs due to sue mizaj Har Yabis (hot & dry temperament) of anus with shadeed Qabz (passing of dry hard stool)12,13,14,15,other causes include passing of Akkaal-khilt (corrosive humours),dietary habits of eating too much khusk (Dry), tursh (sour), Qābid ̣ (astringent) items, tafarruq wa ittesal (Trauma), external barudat (cold) and as a complication of bawaseer (Pile) and nasoor (fistula)14,15
Fissure is derived from a Latin word “Fissura” which means a groove, natural division, cleft, furrow, ulcer or crack like sore.8 Recamier in 1829 first described anal fissure as a painful linear tear at the muco-cutaneous junction of the lower anal canal which extends from anal verge proximally towards dentate line, but not beyond it.16 The cause of an anal fissure is not completely understood but certain etiologic factors such as trauma caused by the strained evacuation of a hard stool, less commonly from diarrhoea, has been proposed to cause anal fissure.8
Anal fissure is classified into:
1. Acute (within 6 weeks duration).
2. Chronic (more than 6-8 weeks of duration).
In Unani system of medicine, the Usool-e-Ilaj (principle of treatment) of fissure in ano in classical text is given as, use of high fibrous diet and laxatives15,22 avoidance of Tursh (sour), Qābiz ̣ (astringent) and Khushk (dry) items.15,23 along with a lot of formulations containing several Unani single drugs having properties of Muhallil- warm (Anti-inflammatory), Mundamil (healing agent), Muzliq (lubricant),
Mujaffif (desiccant) and Muskkin alam (analgesic) which are indicated in the treatment of anal fissures.24,25,26,27
According to different Unani literature, Roghan-e-Gandum, Roghan-e-Aas, fine powder of silkworms, Shib-e-Yamani biryan, fine powder of Gule Surkh, Dam-ul-Akhwain, Gogul, Rasout, Egg yolk, Usara-e-Kasni, Usara-e-Makoh, Zaroor-e-Anzaroot, Marham-e-Safedab, Marham-e-Shadanj, Marham-e-Shiqaq, Zaroor-e-Aelwa, Gil-e-Qaimoolia, Kakanaj, Roghan-e-Gul are some different Unani drugs mentioned as local application for treatment of anal fissures.
 
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