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

Primary Purpose

Cirrhosis Related Parkinsonism

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Lactulose+Rifaximin +Bromocriptine
Sponsored by
Institute of Liver and Biliary Sciences, India
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cirrhosis Related Parkinsonism

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Institute of Liver & Biliary Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Lactulose + Rifaximin + Bromocriptine

Lactulose+Rifaximin+Placebo

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 12, 2014
Last Updated
November 21, 2016
Sponsor
Institute of Liver and Biliary Sciences, India
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1. Study Identification

Unique Protocol Identification Number
NCT02265484
Brief Title
To Study the Efficacy of Bromocriptine in Patients With Hepatic/Cirrhosis Related Parkinsonism
Official Title
A Randomized Open Labelled Placebo Controlled Trial to Study the Efficacy of Bromocriptine in Patients With Hepatic/Cirrhosis Related Parkinsonism
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Liver and Biliary Sciences, India

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhosis Related Parkinsonism

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lactulose + Rifaximin + Bromocriptine
Arm Type
Experimental
Arm Title
Lactulose+Rifaximin+Placebo
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Lactulose+Rifaximin +Bromocriptine
Primary Outcome Measure Information:
Title
The primary outcome will be decrement in UPDRS (Unified Parkinson's Disease Rating Scale) score by 30 %.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
The secondary end point will be decrement in UPDRS (Unified Parkinson's Disease Rating Scale) score of 10% to 30%.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amrish Sahney, MD
Organizational Affiliation
Institute of Liver & Biliary Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Liver & Biliary Sciences
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110070
Country
India

12. IPD Sharing Statement

Citations:
PubMed Identifier
30554466
Citation
Sahney A, Sharma BC, Jindal A, Anand L, Arora V, Vijayaraghavan R, Dhamija RM, Kumar G, Bhardwaj A, Sarin SK. A double-blind randomized controlled trial to assess efficacy of bromocriptine in cirrhotic patients with hepatic parkinsonism. Liver Int. 2019 Apr;39(4):684-693. doi: 10.1111/liv.14024. Epub 2019 Feb 4.
Results Reference
derived

Learn more about this trial

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

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