| CTRI Number |
CTRI/2025/03/081940 [Registered on: 07/03/2025] Trial Registered Prospectively |
| Last Modified On: |
28/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the efficacy of Itrifal Muqil and Habb-E-Barg-E Neeb in internal piles |
|
Scientific Title of Study
|
Comparative Evaluation of Itrifal Muqil and Habb-E-Barg-E Neeb in Bawaseer Ghaira (Internal Haemorrhoids)-A Randomized Clinical Trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Hafsa Naaz T A |
| Designation |
PG Scholar |
| Affiliation |
National institute of Unani Medicine |
| Address |
National institute of Unani Medicine kottigepalya Magadi main road Bangalore
Dept of surgery OPD no 7
Bangalore
KARNATAKA
560091
India |
| Phone |
8660739679 |
| Fax |
|
| Email |
drhafsa196@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Hafsa Naaz T A |
| Designation |
PG Scholar |
| Affiliation |
National institute of Unani Medicine |
| Address |
National institute of Unani Medicine kottigepalya Magadi main road Bangalore
Dept of surgery OPD no 7
Bangalore
KARNATAKA
560091
India |
| Phone |
8660739679 |
| Fax |
|
| Email |
drhafsa196@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Hafsa Naaz T A |
| Designation |
PG Scholar |
| Affiliation |
National institute of Unani Medicine |
| Address |
National institute of Unani Medicine kottigepalya Magadi main road Bangalore
Dept of surgery OPD no 7
Bangalore
KARNATAKA
560091
India |
| Phone |
8660739679 |
| Fax |
|
| Email |
drhafsa196@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Unani Medicine kottigepalya Magadi main road Bangalore |
|
|
Primary Sponsor
|
| Name |
National Institute of Unani Medicine |
| Address |
National Institute of Unani Medicine Kottigepalya Magadi main road Bangalore 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 |
| DrFirdous Ahmad Najar |
National institute of Unani Medicine |
OPD no 7 dept of surgery kottigepalya Magadi main road Bangalore,560091
Bangalore
KARNATAKA |
7483144988
drfirdous2012@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Communication of Decision of the institutional ethics committee (IEC) for Biomedical research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K648||Other hemorrhoids, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Habb-E-Barg-E Neeb |
Barg-e-neeb,chakso,sandal surkh,Dhamasa, Barg-e-hina,Rasaut,Narkachoor,Filfil siyah,loab-e-Behi dana
500mg 2 pills thrice a day for 4 weeks |
| Comparator Agent |
Itrifal Muqil |
Amla,post-e-baleela,Halela kabuli,Muqil azraq,Aab-e-gandana, Honey
11gms once a day for 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed case of internal hemorrhoids gradeI and II
All Genders
Age 18 to 60 years
Patients who have agreed to sign the informed consent form and follow up the protocol |
|
| ExclusionCriteria |
| Details |
External pile mass
Severe systemic illness, IBD, liver cirrhosis
Pregnant and lactating women |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in the objective parameters i.e decrease in rectal mass if any and resolution of bleeding points or mucus bulge
4 weeks |
Improvement in the objective parameters i.e decrease in rectal mass if any and resolution of bleeding points or mucus bulge
4 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in subjective parameters i.e resolution of per rectal bleeding, mucus discharge, defecation discomfort and itching |
Nil |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
10/03/2025 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Haemorrhoids are very common anorectal problem in human beings.It is specialized highly vascular cushion of thick sub mucosa, containing blood vessels, smooth muscles,and elastic and connective tissue which may slide down due to weakness of collagen and anchoring supporting connective tissue.Haemorrhoids are common in patients with constipation, chronic diarrhoea,poor bathroom habits, sedentary lifestyle with a poor fibre diet.Haemorrhoids are treated conservatively with various techniques including dietary improvements, fibre supplements, avoiding undue straining and topical ointments to maintain soft regular stools.Thus,the present study aims to evaluate this formulation scientifically and to validate the efficacy of Unani drugs with the main objective is to provide cost-effective and easily available treatment without adverse effects,the present study is entitled "Comparative evaluation of Itrifal Muqil and Habb-E-Barg-E Neeb in Bawaseer-e-Ghaira ( internal hemorrhoids) "is proposed. |