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CTRI Number  CTRI/2023/04/052077 [Registered on: 27/04/2023] Trial Registered Prospectively
Last Modified On: 27/04/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Unani
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Unani treatment for fissure in ano 
Scientific Title of Study   A comparative evaluation of Marham-e-Basaliqoon versus lateral internal sphincterotomy in treatment of Shiqaq-ul-Maqad(anal fissure). A randomized comparative standard control study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  SHOWKAT BASHIR LONE 
Designation  PG SCHOLAR DEPARTMENT OF ILMUL JARAHAT 
Affiliation  NATIONAL INSTITUTE OF UNANI MEDICINE, 
Address  NATIONAL INSTITUTE OF UNANI MEDICINE, KOTTIGEPALYA, MAGADI MAIN ROAD BENGALURU-91
NATIONAL INSTITUTE OF UNANI MEDICINE, KOTTIGEPALYA, MAGADI MAIN ROAD BENGALURU-91
Bangalore
KARNATAKA
560091
India 
Phone  9682369830  
Fax    
Email  Rehanlone555@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr MEHJABEEN FATIMAH 
Designation  Assistant professor, Department of ilmul jarahat 
Affiliation  NATIONAL INSTITUTE OF UNANI MEDICINE 
Address  NATIONAL INSTITUTE OF UNANI MEDICINE, KOTTIGEPALYA, MAGADI MAIN ROAD BENGALURU-91
NATIONAL INSTITUTE OF UNANI MEDICINE, KOTTIGEPALYA, MAGADI MAIN ROAD BENGALURU-91
Bangalore
KARNATAKA
560091
India 
Phone  8057438462  
Fax    
Email  fatimahmehjabeen@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr MEHJABEEN FATIMAH 
Designation  Assistant professor, Department of ilmul jarahat 
Affiliation  NATIONAL INSTITUTE OF UNANI MEDICINE 
Address  NATIONAL INSTITUTE OF UNANI MEDICINE, KOTTIGEPALYA, MAGADI MAIN ROAD BENGALURU-91
NATIONAL INSTITUTE OF UNANI MEDICINE, KOTTIGEPALYA, MAGADI MAIN ROAD BENGALURU-91
Bangalore
KARNATAKA
560091
India 
Phone  8057438462  
Fax    
Email  fatimahmehjabeen@gmail.com  
 
Source of Monetary or Material Support  
NATIONAL INSTITUTE OF UNANI MEDICINE 
 
Primary Sponsor  
Name  NATIONAL INSTITUTE OF UNANI MEDICINE 
Address  NATIONAL INSTITUTE OF UNANI MEDICINE, KOTTIGEPALYA, MAGADI MAIN ROAD BENGALURU-91 
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 
SHOWKAT BASHIR LONE  HOSPITAL OF NATIONAL INSTITUTE OF UNANI MEDICINE  Department of ilmul-Jarahat, OPD-07. Kottigepalya, Magadi main road Bangalore.
Bangalore
KARNATAKA 		 9682369830

Rehanlone555@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Communication of decision of 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: K602||Anal fissure, unspecified, (2) ICD-10 Condition: K602||Anal fissure, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Lateral internal sphincterotomy (LIS).  Surgical procedure Lateral internal sphincterotomy (LIS) will be done in group B patients under anesthesia. Patients will be followed up and accessed after 7th, 14th and 21st day and 1 month after procedure in group B.  
Intervention  MARHAM-E-BASALIQOON.   7gm of MARHAM-E-BASALIQOON will be applied twice daily over the anal fissure locally with the help of index finger by the patient as advised for a duration of 21 days. Ingredients of MARHAM-E-BASALIQOON: 01. Raughan-e-Sarson(Brassica Camperstris Lin.)-200ml 02. Mom Zard(Cera Alba)-100gm 03. Raal Safed(Shorea rubusta)-40gm 04. Behroza(Pinus Roxiburghi)-20gm 05. Shibbe-yamani Biryan(Potassium Aluminum Sulphate)-10gm 06. Mastagi(Pistacia lenticus Lin.)-10gm a paste/cream will be prepared from above mentioned ingredients and will be applied over the anal fissure of group A patients. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Anal Fissure.
 
 
ExclusionCriteria 
Details  1. Fissure associated with third and fourth degree or thrombosed piles.
2. Malignancy.
3. Severe systemic diseases.
4. Multiple fissures.
5. Pregnant women.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Healing of fissure (Yes/No).
2. Pain during and after defecation (VAS) 0-10 grade.
3. Per rectal bleeding 		 21 days 
 
Secondary Outcome  
Outcome  TimePoints 
1. Tenderness on Digital examination (Yes/No).
2. Anal sphincter Spasm (Yes/No).
 		 21 days 
 
Target Sample Size   Total Sample Size="42"
Sample Size from India="42" 
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 2 
Date of First Enrollment (India)   01/05/2023 
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   After completion of this trial a research paper on the trail will be published in peer reviewed or international journal.  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   ShuqaÌ„q-ul-maq‘ad (fissure in ano), according to the Unani system of medicine, is caused by Hararat-wa-Yabusat (hot & dry temperament) Khushk-Baraz or Shadeed-Qabz (dry hard stool), Waram-e-har (acute inflammation), Ishal (diarrhoea), Fasid-fuzlaat (Morbid substance), Waram-e-Barid-wa-reehi of anal canal, passage of Tez-AkhlaÌ„t and zarba-wa-sakta (trauma).
In Classical text books it has been mentioned by almost all Unani physicians that Anal fissure is shigaff(tear) in anal canal caused by various reasons among which most common cause is Sū-e-Mizāj-Hārr-Yābis of Maqád and passage of dry hard stool. Other causes include passage of Akkāl khilt (corrosive humours), dietary habits of eating too much Khushk(dry), Tursh(sour), Akkālkhilt (corrosive humours), Qabiz(astringent) items, trauma, external Burūdat and as a complication of Bawāsīr & Nāsūr . In Unani system of medicine the Usool-e-Ilaj (principle of treatment) of fissure in ano is almost same as in allopathic system of medicine, such as use of high fibrous diet and laxatives. Avoidance of Tursh (sour), Qabiz(Constipative) and Khushk (dry) items . In addition several single and compound Unani drugs are indicated for anal fissures treatment having property of Mundammil(Healing), Muhallil-e-Awraam(Anti- inflammatory), Muzliq(Lubricant), Murattib(Humectant), Mulayyin (Laxative) & Mujaffif (Desiccants).
Number of formulations are mentioned in classical literature of Unani system of  medicine for treatment of anal fissures. So, using these formulations for treatment will provide an inexpensive, effective and alternative way for the management of anal fissure. So, in view of common prevalence and drawbacks like non-availability of affordable and safe treatment of anal fissure in conventional system of medicine the present study is being designed to manage the anal fissure by application of a Unani formulation Marham-e-Basaliqoon  with main objective to find out a convenient non operative, painless, safe, affordable and efficient remedy and this classical medicine will be compared with Lateral internal sphincterotomy.
 
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