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CTRI Number  CTRI/2020/05/025177 [Registered on: 14/05/2020] Trial Registered Prospectively
Last Modified On: 13/05/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Unani 
Study Design  Single Arm Study 
Public Title of Study   Herbal treatment for hemorrhoid 
Scientific Title of Study   Efficacy of Itrifal muqil in Bawaseer-e-ghaira (Internal haemorrhoids) - An observational clinical study. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  MOHAMMAD SHOEB MANSOORI 
Designation  PG SCHOLAR DEPARTMENT OF ILMUL JARAHAT 
Affiliation  NATIONAL INSTITUTE OF UNANI MEDICINE, BANGALORE-91 
Address  Room No 25 Boys Hostel National Institute Of Unani Medicine Kottigepalya Magadi Main Road Bangalore Karnataka

Bangalore
KARNATAKA
560091
India 
Phone  8887958780  
Fax    
Email  shoeb.knp111@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  MOHAMMAD SHOEB MANSOORI 
Designation  PG SCHOLAR DEPARTMENT OF ILMUL JARAHAT 
Affiliation  NATIONAL INSTITUE OF UNANI MEDICINE 
Address  Room No 25 Boys Hostel Department of Ilmul Jarahat National Institute of Unani Medicine Kottigepalya Magadi Main Road Bangalore Karnataka

Bangalore
KARNATAKA
560091
India 
Phone  8057438462  
Fax    
Email  shoeb.knp111@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR MEHJABEEN FATIMAH 
Designation  Lecturer Department of Ilmul Jarahat 
Affiliation  NATIONAL INSTITUE OF UNANI MEDICINE 
Address  Department of Ilmul Jarahat National Institute of Unani Medicine Kottigepalya Magadi Main Road Bangalore Karnataka

Bangalore
KARNATAKA
560091
India 
Phone  8057438462  
Fax    
Email  fatimahmehjabeen@gmail.com  
 
Source of Monetary or Material Support  
National Institute Of Unani Medicine Kottigepalya Magadi Main Road Bengaluru Karnataka 560091 
 
Primary Sponsor  
Name  NATIONAL INSTITUE OF UNANI MEDICINE 
Address  Kottigepalya Magadi Main Road Bangalore Karnataka 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 
Mohammad Shoeb Mansoori  NATIONAL INSTITUTE OF UNANI MEDICINE  Opd No 07 Department of Ilmul Jarahat Kottigepalya Magadi Main Road Bangalore Karnataka 560091
Bangalore
KARNATAKA 
8887958780

shoeb.knp111@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: K641||Second degree hemorrhoids,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Itrifal muqil   7gm Itrifal two times after meal for 45 days.  
Comparator Agent  not applicable  not applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Diagnosed case of internal haemorrhoids of 1st and 2nd degree
Patients who have agreed to sign the informed consent form and follow up the protocol 
 
ExclusionCriteria 
Details  3rd& 4th degree of hemorrhoids.
Severe systemic illness.
Diabetes mellitus
Pregnant and lactating women.
Hemorrhoids associated with other Anorectal diseases like Rectal polyp, Fissure in Ano, Fistula in Ano, Carcinoma of Rectum and Anal canal etc.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Complete Regression of pile mass  21days 
 
Secondary Outcome  
Outcome  TimePoints 
Subjective parameters Per rectal
Painless bleeding
Mass coming during defecation and reduces itself
Mucus discharge
Itching

Objective parameters
Rectal examination and Proctoscopy
Bleeding points Number
Positions & Degree of masses
 
0,7,14 & 21 days 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   15/05/2020 
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)?  

Brief Summary  

As per Unani literature haemorrhoid is known as “Bawaseer”. Bawaseer is pleural of basoor which means warts or polyp like swelling. It is an excessive growth at the mouth of vessels present in anus which forms due to ghaleez khilt-e-sauda. Buqrat (Hippocrates) described the haemorrhoids as the flow of blood from the veins of anus. .According to Majoosi, Bawaseer is an excessive growth at mouth of vessels present in anus. Whereas Ibn Hubal Baghdadi described that the formation of Bawaseer indicates that the morbid viscid humour (ghaleez akhalat) is present in the body. Unani physicians described that the khilt-e-sauda is responsible for this disease. The basic principle of management of Haemorrhoids are Izale-sabab (elimination of cause) that means avoid the food (diet) which forms khilt-e-sauda in body, Tanqiya-e-ma‘dda (evacuation of morbid matter) through venesection, cupping and laxatives. Other methods which can be used for the treatment of haemorrhoids include correction of liver, intestine, stomach and spleen because haemorrhoids can never form without Su-e-mizaj of these organs. Exercise like brisk walk and use of Hamam to dissolve the morbid matterThe Itrifal prepared from Unani formulation (Halela kabuli, Post-e-balela, Amla muqashar, Muqil arzaq, Aab-e-gandana and Honey) has specific action in treatment of Bawaseer-e-ghaira. Halela kabuli has property of evacuation of Sauda, Balela has the property to remove the toxins from blood as well as evacuate the sauda. Amla possess the property of evacuation of sauda, acts as haemostatic & laxative. Aab-e-gandana act as haemostatic and Muqil has haemostatic as well as laxative properties Dose: three misqal(13.5gm) in divided dose per day after meal for 45 days

 
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