Comparison of three drugs named metronidazole, tinidazole and secnidazole for effectiveness in patients of liver abscess

Phase 3

Recruiting

• Conditions: Abscess of liver,

• Registration Number: CTRI/2022/01/039430
• Lead Sponsor: Dr BSA Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-31
• Last Update Posted: 2023-10-09

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

All consenting patients presenting to surgery opd/emergency in given duration of time with evidence of single liver abscess.

Exclusion Criteria

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Dr. Baba Saheb Ambedkar Hospital; 🇮🇳 North, DELHI, India

Dr. Baba Saheb Ambedkar Hospital

🇮🇳North, DELHI, India

Jitendra Kumar

Principal investigator

7290095445

jkumar33@ymail.com