To Study the Efficacy of Bromocriptine in Patients With Hepatic/Cirrhosis Related Parkinsonism

Not Applicable

Completed

• Conditions: Cirrhosis Related Parkinsonism
• Interventions: Drug: Lactulose+Rifaximin +Bromocriptine

• Registration Number: NCT02265484
• Lead Sponsor: Institute of Liver and Biliary Sciences, India

Brief Summary

After successful screening of liver cirrhosis patients attending ILBS OPD for signs of parkinsonism ( tremor, rigidity or bradykinesia, any 2 of 3). Diagnosis of hepatic/cirrhosis related parkinsonism will be made. Patients will be randomized into Bromocriptine and Placebo. Patients will be followed up every month in OPD (Out Patient Department), ILBS (Institute of liver \& Biliary Sciences) for 3 months. Detailed neurological examination will be done at each visit \& UPDRS (Unified Parkinson's Disease Rating Scale ) score will be calculated.

Detailed Description

Not available

Study Timeline

• Status Verified: 2013-04
• Study Start: 2013-11
• Study First Submitted: 2014-09-12
• Study First Submitted QC: 2014-10-10
• Study First Posted: 2014-10-16
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Last Update Submitted: 2016-11-21
• Last Update Posted: 2016-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Patients with cirrhosis of liver with signs of parkinsonisms
• Patients consented for the study protocol by signing the informed consent.

Exclusion Criteria

• Age < 18 years.
• Patient s with HCC (Hepatocellular Carcinoma).
• Patients diagnosed as Wilsons disease.
• Patient who withdrew or non complaint to the study protocol.
• ALF (Acute Liver failure)
• Classical Parkinsonism
• Atypical Parkinsonism
• Pregnancy
• Hypotension
• Uncontrolled hypertension
• CAD
• Psychiatric illness
• Acute episode of Hepatic encephlopathy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lactulose + Rifaximin + Bromocriptine	Lactulose+Rifaximin +Bromocriptine	-
Lactulose+Rifaximin+Placebo	Lactulose+Rifaximin +Bromocriptine	-

Primary Outcome Measures

Name	Time	Method
The primary outcome will be decrement in UPDRS (Unified Parkinson's Disease Rating Scale) score by 30 %.	3 months

Secondary Outcome Measures

Name	Time	Method
The secondary end point will be decrement in UPDRS (Unified Parkinson's Disease Rating Scale) score of 10% to 30%.	3 months

Trial Locations

Locations (1)

Institute of Liver & Biliary Sciences; 🇮🇳 New Delhi, Delhi, India