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
|
|
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
|
|
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 “Bawaseerâ€. 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 |