| CTRI Number |
CTRI/2022/01/039430 [Registered on: 14/01/2022] Trial Registered Prospectively |
| Last Modified On: |
10/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparison of three drugs named metronidazole, tinidazole and secnidazole for effectiveness in patients of liver abscess |
|
Scientific Title of Study
|
Triple Arm Randomised Controlled Trial Comparing Metronidazole, Tinidazole And Secnidazole For The Efficacy In The Patients Of Amoebic Liver Abscess (TARMENTS TRIAL) |
| Trial Acronym |
TARMENTS Trial |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jitnendra Kumar |
| Designation |
HOD, Surgery |
| Affiliation |
DR. Baba Saheb Ambedkar Hospital |
| Address |
Department of Surgery,
BSA Hospital, Rohini,
New Delhi 110085
Sec-6, Rohini,
New Delhi
110085
North
DELHI
110085
India |
| Phone |
7290095445 |
| Fax |
|
| Email |
jkumar33@ymail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shardool Vikram Gupta |
| Designation |
Assistant Professor |
| Affiliation |
DR. Baba Saheb Ambedkar Hospital |
| Address |
Department of Surgery,
BSA Hospital, Rohini,
New Delhi 110085
Sec-6, Rohini,
New Delhi
110085
North
DELHI
110085
India |
| Phone |
9971265738 |
| Fax |
|
| Email |
drshardool@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Samar Iftikhar |
| Designation |
Junior Resident |
| Affiliation |
DR. Baba Saheb Ambedkar Hospital |
| Address |
Department of Surgery,
BSA Hospital, Rohini,
New Delhi 110085
Sec-6, Rohini,
New Delhi
110085
North
DELHI
110085
India |
| Phone |
9899008216 |
| Fax |
|
| Email |
samar212.94@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr BSA Hospital |
| Address |
Sec 6, Rohini,
New Delhi
110085 |
| 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 |
| Jitendra Kumar |
Dr. Baba Saheb Ambedkar Hospital |
Department of Surgery, Ward 32 and 52, BSA Hospital, Sec 6, Rohini,
New Delhi 110085
North
DELHI |
7290095445
jkumar33@ymail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee Dr Baba saheb ambedkar medical college and hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K750||Abscess of liver, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
metronidazole |
Tablet Metronidazole 800 mg TDS or injectable metronidazole 1 g iv 8 hourly for 10 days will be given to patients of liver abscess randomised into metronidazole group. |
| Comparator Agent |
Secnidazole |
Tablet Secnidazole 1 g BD or injectable SECNIDAZOLE 1 g iv 12 hourly for 5 days will be given to patients of liver abscess randomised into Secnidazole group. |
| Comparator Agent |
Tinidazole |
Tablet Tinidazole 1 g BD or injectable tinidazole 800 mg iv 12 hourly for 5 days will be given to patients of liver abscess randomised into tinidazole group. |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All consenting patients presenting to surgery opd/emergency in given duration of time with evidence of single liver abscess.
|
|
| ExclusionCriteria |
| Details |
1.USG evidence of presence of multiple liver abscesses.
2.Clinical signs and symptoms of intraperitoneal rupture of abscess.
3.Very sick patient requiring ICU admission
4.Age <10 years or >60 years
5.Pregnant women
6.Patient with history of malignancy past or present
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of Metronidazole vs Tinidazole vs Secnidazole in a triple arm randomised controlled trial study in patients of Amoebic Liver Abscess.The efficacy will be assessed by resolution of symptoms and signs like fever, abdominal pain, right hypochondrium tenderness and leucocytosis. |
At 1 month and 3 months from date of discharge |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To compare the incidence of complications like intra peritoneal rupture, pleural effusion, atelectasis
2.To report drug related side effect like nausea, metallic taste, peripheral neuropathy, caecal perforation, colitis
3.Patient Satisfaction Score
|
At 1 month and 3 months from date of discharge |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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 3 |
|
Date of First Enrollment (India)
|
31/01/2022 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study will be conducted at Department of General Surgery, Dr Baba Saheb Ambedkar Hospital, Rohini, Delhi-85. All the patients with Amoebic Liver Abscess meeting inclusion criteria will be included in this study. Patients will be randomised into three groups MEN,TIN and SEC and will receive metronidazole, tinidazole and secnidazole respectively. Patients will be observed for resolution of symptoms and lab parameters.They will also be monitored for any drug related side effects.They will be observed for clinical response, lab parameters imaging and side effects.All patients will be followed up at 1 month and 3 months from date of discharge.
|