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

Cirrhosis Related Parkinsonism Clinical Trial

Official title:

A Randomized Open Labelled Placebo Controlled Trial to Study the Efficacy of Bromocriptine in Patients With Hepatic/Cirrhosis Related Parkinsonism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02265484
• Other study ID #: ILBS-bromocriptine-01
• Status: Completed
• Phase: N/A
• First received: September 12, 2014
• Last updated: November 21, 2016
• Start date: November 2013
• Est. completion date: January 2015

Study information

• Verified date: April 2013
• Source: Institute of Liver and Biliary Sciences, India
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cirrhosis Related Parkinsonism
• Fibrosis
• Liver Cirrhosis
• Parkinsonian Disorders

Intervention

Drug:
• Lactulose+Rifaximin +Bromocriptine

Locations

Country	Name	City	State
India	Institute of Liver & Biliary Sciences	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Liver and Biliary Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome will be decrement in UPDRS (Unified Parkinson's Disease Rating Scale) score by 30 %.		3 months	No
Secondary	The secondary end point will be decrement in UPDRS (Unified Parkinson's Disease Rating Scale) score of 10% to 30%.		3 months	No