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

November 21, 2016 updated by: Institute of Liver and Biliary Sciences, India

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Delhi
      • New Delhi, Delhi, India, 110070
        • Institute of Liver & Biliary Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Liver and Biliary Sciences, India

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

September 12, 2014

First Submitted That Met QC Criteria

October 10, 2014

First Posted (Estimate)

October 16, 2014

Study Record Updates

Last Update Posted (Estimate)

November 22, 2016

Last Update Submitted That Met QC Criteria

November 21, 2016

Last Verified

April 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ILBS-bromocriptine-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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