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To study the gallbladder function in patient with gallstones and the effect of short course of antibiotic in improving in gallbladder function

TO COMPARE CLINICAL, DEMOGRAPHIC, GALL STONE PROFILE AND GALL BLADDER FUNCTION OF PATIENTS WITH SYMPTOMATIC AND ASYMPTOMATIC GALL STONES.

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/03/018109
Enrollment
100
Registered
2019-03-15
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K802- Calculus of gallbladder without cholecystitis

Interventions

Intervention1: LEVOFLOXACIN 500 MG: CAP Levofloxacin 500 mg will be given after randomization for 10 days Control Intervention1: Identical looking placebo.: This identical looking placebo will be give

Sponsors

PGIMER
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patient with ultrasound documented Gall stones willing to participate in the study

Exclusion criteria

Exclusion criteria: 1) Radiographic Evidence of presence of gallbladder mass or wall thickening suggestive of Gall Bladder malignancy 2) Biliary obstruction as evidenced by jaundice, dilated common bile duct, Intra-hepatic biliary radicles. 3) H/o of malignancy at any other site/ any serious systemic illness. Total parenteral nutrition. 4) Pregnancy/Postpartum state (6 months) 5) Patients on opioids, calcium channel blockers or nitrates or receiving octreotide infusion in the preceding 1 month 6) History of of endoscopic intervention in the form of sphincterotomy or biliary stenting 7) Presence of feature suggestive of acute cholecystitis.

Design outcomes

Primary

MeasureTime frame
1) Improvement in Gall Bladder Ejection Fraction 2) To determine prevalence of H. pylori infection among symptomatic and asymptomatic Gall Stones.Timepoint: 3WKS

Secondary

MeasureTime frame
Improvement in Gall bladder function and quality of life.Timepoint: 3 wks

Countries

India

Contacts

Public ContactDR TEJINDER KAUSHAL

PGIMER CHANDIGARH

ushadutta@gmail.com8198877022

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026