| CTRI Number |
CTRI/2024/08/071876 [Registered on: 02/08/2024] Trial Registered Prospectively |
| Last Modified On: |
29/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To evaluate and compare the efficacy of itrifal sagheer and sitz bath with alum in the treatment and management of haemorrhoids 1 & 2 degree |
|
Scientific Title of Study
|
A Clinical Study on 1 degree and 2 degree Haemorrhoids and management with Unani Polyherbal Formulation Itrifal Sagheer and Sitz Bath with Alum A Randomised Standard Controlled Trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Najida Fatima shams |
| Designation |
PG scholar |
| Affiliation |
State takmeel ut tib college and hospital |
| Address |
Dept of Ilmul Jarahat, State Takmeel ut Tib College and Hospital, 226012
Lucknow
UTTAR PRADESH
226012
India |
| Phone |
8630662926 |
| Fax |
|
| Email |
najidashams@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof. Abdul Quawi |
| Designation |
Professor, Dept of Ilmul Jarahat |
| Affiliation |
State takmeel ut tib college and hospital |
| Address |
Dept of Ilmul Jarahat, State Takmeel ut Tib College and Hospital, 226012
Lucknow
UTTAR PRADESH
226012
India |
| Phone |
9826212048 |
| Fax |
|
| Email |
quavinium@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Rakhshinda Baig |
| Designation |
Reader, Dept of Ilmul Jarahat |
| Affiliation |
State takmeel ut tib college and hospital |
| Address |
Dept of Ilmul Jarahat, State Takmeel ut Tib College and Hospital, 226012
Lucknow
UTTAR PRADESH
226012
India |
| Phone |
9415337189 |
| Fax |
|
| Email |
baigrakhshi12@gmail.com |
|
|
Source of Monetary or Material Support
|
| State Takmeel ut Tib College and Hospital, Lucknow, India, 226012 |
|
|
Primary Sponsor
|
| Name |
State Takmeel ut tib College and Hospital |
| Address |
near Ramabai rally sthal Bijnor road Lucknow, India, 226012 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Dr Najida |
State Takmeel ut tib College and Hospital |
Jarahat OPD ground Floor Room no 112 department of ilmul jarahat
Lucknow
UTTAR PRADESH |
8630662926
najidashams@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee state takmeel ut tib college and hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K928||Other specified diseases of the digestive system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Itrifal sagheer and Sitz Bath with Alum |
10 grams TDS orally for 42 days
100 grams of Alum for Sitz bath twice a day for 20 minutes |
| Comparator Agent |
Tab Daflon |
2 tablets BD orally for 15 days |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients of either sex
Clinically diagnosed patients with 1&2 degree haemorrhoids
Per rectal bleeding
Pain during defecation
Itching in anal region |
|
| ExclusionCriteria |
| Details |
Anal warts
Anal fissure
Anal fistula
Carcinoma of anal canal
Perianal abscess diabetes
Severe illness
Ulcerative colitis
Pregnancy
Lactating mother |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To stop bleeding
To stop itching
To shrink prolapsed mass |
7th, 14th, 21st, 28th, 35th, 42nd days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To treat the haemorrhoids |
42 days |
|
|
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 |
|
Date of First Enrollment (India)
|
16/08/2024 |
| 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="10" |
|
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
|
In conclusion, Haemorrhoids are a common medical condition that significantly impacts individuals’ well-being. This research paper provides a comprehensive review of haemorrhoids, covering their anatomy, pathophysiology, clinical presentation, diagnosis and management. By enhancing knowledge about haemorrhoids, healthcare professionals can provide more effective care and support to patients, ultimately improving their quality of life. Further research is essential to develop innovative treatment approaches and preventive strategies to address the burden of haemorrhoids on a global scale. Understanding the diverse clinical features of haemorrhoids allows healthcare professionals to offer precise diagnosis and tailored therapeutic management, leading to improved treatment outcomes and quality of life for affected individuals. Ongoing research and clinical observation are necessary to refine diagnostic modalities and therapeutic strategies, thereby reducing the global burden of haemorrhoidal disease. This reasearch work is an endeavor aimed at treating Gr I &II haemorrhoids using the unani compound (murakkab) drug “Itrifal Sagheer†|