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CTRI Number  CTRI/2019/05/019443 [Registered on: 30/05/2019] Trial Registered Prospectively
Last Modified On: 28/05/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Unani 
Study Design  Single Arm Study 
Public Title of Study   Treatment of haemorrhoid in unani system of medicine 
Scientific Title of Study   Efficacy of a Unani formulation in Bawaseer-e-ghaira (Internal haemorrhoids of first and second degree)- An observational clinical study. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIUM/IEC/2017-18/026/Jar/01  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Khan Momina Shamsulhuda 
Designation  PG Scholar 
Affiliation  National Institute of Unani Medicine 
Address  Department of Jarahiyat, PG Scholar, national institute of unani medicine, kottigepalya, magadi road

Bangalore
KARNATAKA
560091
India 
Phone  8971738930  
Fax    
Email  drkhanmomina@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mehjabeen fatimah 
Designation  lecturer 
Affiliation  NATIONAL INSTITUTE OF UNANI MEDICINE 
Address  Department of Jarahiyat, national institute of unani medicine, kottigepalya, magadi road

Bangalore
KARNATAKA
560091
India 
Phone  8057438462  
Fax    
Email  fatimahmehjabeen@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Mehjabeen fatimah 
Designation  lecturer 
Affiliation  NATIONAL INSTITUTE OF UNANI MEDICINE 
Address  Department of Jarahiyat, national institute of unani medicine, kottigepalya, magadi road


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  kottigepalya, magadi road, bangalore, karnataka, 560091 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
national institute of unani medicine  kottigepalya, magadi road, bangalore, karnataka, 560091 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Khan Momina Shamsulhuda  National Institute of Unani Medicine  OPD NO: 7 Dept.of Ilmul Jarahat kottigepalya, magadi road
Bangalore
KARNATAKA 
8971738930

drkhanmomina@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC-NIUM  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  Unani formulation in Habb form (halela kabuli, kahruba shamai, muqil,aab-e-gandana,roghane gao)  orally 6gms BD for 45 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Diagnosed case of internal haemorrhoids of 1st and 2nd degree
2.Age group 18-60 years
3.Both genders; male and female
4.Patients who have agreed to sign the informed consent form and follow up the protocol.
 
 
ExclusionCriteria 
Details  1.3rd& 4th degree of haemorrhoids
2.Severe systemic illness
3.Pregnant and lactating women
4.Haemorrhoids 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   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Rectal examination and Proctoscopy
(Bleeding points, Number, Positions & Degree of masses)
 
45 days
 
 
Secondary Outcome     
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   Phase 2 
Date of First Enrollment (India)   07/06/2019 
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  

Haemorrhoids are one of the most common anorectal diseases of mankind.The term is derived from two Greek words, haima; blood and rhoos; flowing. The term pile has been derived from Latin word “Pila” which means “a ball”.According to Cerato et al, hemorrhoidal diseases affect 4% of the world population. But according to Ali et al, 50-85% of people around the world had hemorrhoids. Some researchers suggest that about 75% of the people are affected with this disease. It is the common cause of lower G.I. bleed and its frequency in India is 30-40%. According to Gami, more than half of men and women aged 50 years and above will develop hemorrhoid symptoms during their lifetime. Hospital based proctoscopy examinations show prevalence rates of hemorrhoids in 86% of patients. The available treatments of disease are symptomatic i.e.avoidance of excessive straining, better dietary habits supplemented by medication and topical ointments to keep stools soft and regular. Active treatment includes sclerotherapy, barron’s band ligation, cryotherapy, infrared photo-coagulation and surgical treatment.  

In the view of high prevalence and non availability of affordable treatment without side effect, the present study is aimed to manage the disease with Unani formulation “Halela,kabuli, Kahruba shamai, Muqil, Aab-e-gandana, and Roghan-e-gao”9 with main objective to provide cost effective and easily available treatment without adverse effect.

  
 
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