| CTRI Number |
CTRI/2025/03/082316 [Registered on: 13/03/2025] Trial Registered Prospectively |
| Last Modified On: |
04/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To assess the effectiveness of oral micronised purified flavanoid fraction tablet versus topical glycerine magnesium sulphate application in surgical management of hemorrhoids |
|
Scientific Title of Study
|
A Randomised control study using oral micronised purified flavanoid fraction versus topical glycerine magnesium sulphate application in the surgical management of grade 3 and grade 4 external hemorrhoids |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
S Akash |
| Designation |
M.S General surgery postgraduate |
| Affiliation |
SRM medical college hospital and research centre |
| Address |
SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE - DEPARTMENT OF GENERAL SURGERY - ROOM NO 14
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
7904816389 |
| Fax |
|
| Email |
akashsivamurugan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
PROF DR.R.LAKSHMANA |
| Designation |
M.S General surgery FMAS DMAS |
| Affiliation |
SRM medical college hospital and research centre |
| Address |
SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE - DEPARTMENT OF GENERAL SURGERY , SRM nagar , potheri , kattankulathur
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9790828131 |
| Fax |
|
| Email |
drlaksh31@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
PROF Dr Lakshmana R |
| Designation |
M.S General surgery DMAS FMAS |
| Affiliation |
SRM medical college hospital and research centre |
| Address |
SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE - DEPARTMENT OF GENERAL SURGERY - ROOM NO 14 , SRM nagar , potheri , kattankulathur
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9790828131 |
| Fax |
|
| Email |
drlaksh31@gmail.com |
|
|
Source of Monetary or Material Support
|
| self - SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE, POTHERI , TAMILNADU - 603203 |
|
|
Primary Sponsor
|
| Name |
SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE Department of General Surgery |
| Address |
SRM medical college hospital and research centre - POTHERI - TAMILNADU - 603203 |
| 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 |
| Dr S Akash |
SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE - Department of General Surgery |
SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE - DEPARTMENT OF GENERAL SURGERY - ROOM NO 14
Kancheepuram
TAMIL NADU |
7904816389
akashsivamurugan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Centre of clinical Pharmacology, SRM medical college hospital and research centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Use of oral micronised purified flavanoid fraction (daflon) in surgical management of grade 3 and grade 4 external hemorrhoids |
Patients belonging to study group were started on tablet Daflon 500mg – 2tablets twice daily for 4 weeks and were followed up weekly during the study period and proctoscopic examination was conducted at each consultation |
| Comparator Agent |
Use of topical glycerine magnesium sulphate application in surgical management of grade 3 / 4 external hemorrhoids |
Patients belonging to comparator group were started on topical glycerine magnesium sulphate application twice daily for 4 weeks and were followed up weekly during the study period and proctoscopic examination was conducted at each consultation. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients presenting to general surgery opd diagnosed with grade 3 and grade 4 external hemorrhoids |
|
| ExclusionCriteria |
| Details |
patients diagnosed with grade 1 and grade 2 external hemorrhids, internal hemorrhoids, anemia, pregnancy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| improving pain, heaviness, bleeding, pruritus, and mucosal discharge preoperatively , reduced intraoperative bleeding . |
Week 1 , Week 2 , Week 3 , Week 4 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Decreased Postoperative pain and improving overall morbidity |
Week 1 , week 2 , week 3 , week 4 |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
15/03/2025 |
| 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="2"
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
|
In surgical management of Grade 3 and grade 4 external hemorrhoids, by using oral micronised purified flavanoid fraction , there is decreased preoperative bleeding, pain , pruritis, mucosal discharge, decreased intraoperative bleeding and decreased postoperative pain and overall morbidity than using topical glyerine magnesium sulphate. |