To Study the Efficacy of Bromocriptine in Patients With Hepatic/Cirrhosis Related Parkinsonism
Information source: Institute of Liver and Biliary Sciences, India
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hepatic/Cirrhosis Related Parkinsonism.
Intervention: Lactulose+Rifaximin +Bromocriptine (Drug)
Phase: N/A
Status: Completed
Sponsored by: Institute of Liver and Biliary Sciences, India
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.
Clinical Details
Official title: A Randomized Open Labelled Placebo Controlled Trial to Study the Efficacy of Bromocriptine in Patients With Hepatic/Cirrhosis Related Parkinsonism
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: The primary outcome will be decrement in UPDRS (Unified Parkinson's Disease Rating Scale) score by 30 %.
Secondary outcome: The secondary end point will be decrement in UPDRS (Unified Parkinson's Disease Rating Scale) score of 10% to 30%.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Institute of Liver & Biliary Sciences, New Delhi, Delhi 110070, India
Additional Information
Starting date: November 2013
Last updated: April 10, 2015
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