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

• Sponsor: Institute of Liver and Biliary Sciences, India (Other)
• Overall Status: Completed
• CT.gov ID: NCT02265484
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Duration (Months): 14
• Patients Per Site Per Month: 3.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cirrhosis Related Parkinsonism	Drug: Lactulose+Rifaximin +Bromocriptine	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized Open Labelled Placebo Controlled Trial to Study the Efficacy of Bromocriptine in Patients With Hepatic/Cirrhosis Related Parkinsonism
• Study Start Date: Nov 1, 2013
• Actual Primary Completion Date: Jan 1, 2015
• Actual Study Completion Date: Jan 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lactulose + Rifaximin + Bromocriptine	Drug: Lactulose+Rifaximin +Bromocriptine
Active Comparator: Lactulose+Rifaximin+Placebo	Drug: Lactulose+Rifaximin +Bromocriptine

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institute of Liver & Biliary Sciences	New Delhi	Delhi	India	110070

Sponsors and Collaborators

• Institute of Liver and Biliary Sciences, India

Investigators

• Principal Investigator: Amrish Sahney, MD, Institute of Liver & Biliary Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Institute of Liver and Biliary Sciences, India
• ClinicalTrials.gov Identifier: NCT02265484
• Other Study ID Numbers: ILBS-bromocriptine-01
• First Posted: Oct 16, 2014
• Last Update Posted: Nov 22, 2016
• Last Verified: Apr 1, 2013

• Additional relevant MeSH terms: Liver Cirrhosis; Parkinsonian Disorders; Fibrosis; Rifaximin; Bromocriptine; Lactulose

Study Results

No Results Posted as of Nov 22, 2016