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
|
|
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 “Pilaâ€
which means “a ballâ€.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-gaoâ€9 with main objective to provide cost effective and easily available
treatment without adverse effect.
|