| CTRI Number |
CTRI/2018/01/011101 [Registered on: 02/01/2018] Trial Registered Retrospectively |
| Last Modified On: |
22/12/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Study to compare three different day care treatment for early stage haemorrhoids |
|
Scientific Title of Study
|
Study of the clinical outcomes following outpatient management of early stage Haemorrhoids |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Manoj Kumar |
| Designation |
Associate Professor |
| Affiliation |
Armed Forces Medical College, Pune |
| Address |
Department Of Surgery
Armed Forces Medical College
Sholapur Road
Pune
Pune
MAHARASHTRA
411040
India |
| Phone |
9765274924 |
| Fax |
|
| Email |
drmanojsurgeon@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manoj Kumar |
| Designation |
Associate Professor |
| Affiliation |
Armed Forces Medical College, Pune |
| Address |
Department Of Surgery
Armed Forces Medical College
Sholapur Road
Pune
Pune
MAHARASHTRA
411040
India |
| Phone |
9765274924 |
| Fax |
|
| Email |
drmanojsurgeon@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ranjan Kumar |
| Designation |
Junior Resident, General Surgery |
| Affiliation |
Armed Forces Medical College, Pune |
| Address |
Department Of Surgery
Armed Forces Medical College
Sholapur Road
Pune
Pune
MAHARASHTRA
411040
India |
| Phone |
9928401961 |
| Fax |
|
| Email |
ranjan_afmc@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Department of Surgery
Armed Forces Medical College
Pune
Maharastra - 411040 |
|
|
Primary Sponsor
|
| Name |
Armed Forces Medical College |
| Address |
Sholapur Road
Pune - 411040 |
| 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 Manoj Kumar |
Armed Forces Medical College, Command Hospital (Southern Command) |
Room No 10(civil
Polyclinic) Surgical
Division Department of
Surgery
Pune
Maharastra
Pune
MAHARASHTRA |
9765274924
drmanojsurgeon@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Commitee, AFMC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Grade 1 and 2 haemorrhoids, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Flavanoids(Daflon) |
Flavonoids (Daflon) 500 mg bd used along with
seitz bath, stool softners, standard analgesia
|
| Intervention |
Injection Sclerotherapy |
Injection sclerotherapy (Inj Polidocanal 1% ) done for the haemorrhoid followed by antibiotic cover, short duration laxatives, standard analgesia (lignocaine local and paracetamol 50 mg/kg/day) |
| Intervention |
Rubber band ligation |
Rubber band ligation done for the haemorrhoid followed by antibiotic cover, short duration laxatives, standard analgesia (lignocaine local and paracetamol 50 mg/kg/day) |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
All symptomatic patients with grade 1 and 2 haemorrhoids |
|
| ExclusionCriteria |
| Details |
Patients of haemorrhoids grade 1 & 2 with
1.Rectal carcinoma
2.Hepatic cirrhosis / Portal hypertension
3.Recurrent / treated haemorrhoids
4.Associated anal pathology with fissure/ fistula
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief of symptoms of bleeding per rectum,pain/discomfort, post procedure symptoms |
Post procedure/intervention day 01, 07 and 30 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Residual haemorrhoids |
3 months |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
25/11/2016 |
| 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) |
Open to Recruitment |
|
Publication Details
|
No publications |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A total of 120 patients of grade 1 and 2 haemorrhoids who are symptomatic will be the part of this trail. It will be a randomized parallel group, multiple arm trial. One group will treated by Rubber band liagation, followed by antibiotic cover, laxatives and standard analgesia( Lignocaine gel 2% and Paracetamol tablet 50 mg/kg/day). Second group will be treated with Injection Sclerotherapy (Polidocanol 1 %), followed by antibiotic cover, laxatives and standard analgesia (Lignocaine gel 2 % and Paracetamol 50 mg/kg/day). Third group will be treated with systemic Flavanoids (Tablet Daflon 500 mg twice a day), sitz bath, laxatives and standard analgesia (Lignocaine gel 2 % and Paracetamol 50 mg/kg/day). Therapy will be assessed in terms of patient comfort, symptom relief, complications if any and complete resolution of the disease. Analysis of the data will be done by an appropriate statistical tests.
|