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

Institute of Liver and Biliary Sciences, India

Status: Completed

Conditions: Cirrhosis Related Parkinsonism

Treatments: Drug: Lactulose+Rifaximin +Bromocriptine

Study type: Interventional

Funder types: Other

Identifiers

NCT02265484

ILBS-bromocriptine-01

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Lactulose + Rifaximin + Bromocriptine

Experimental group

Treatment:

Drug: Lactulose+Rifaximin +Bromocriptine

Lactulose+Rifaximin+Placebo

Active Comparator group

Treatment:

Drug: Lactulose+Rifaximin +Bromocriptine