A clinical study of IBH-B, a nutritional adjuvant to L-Dopa, in Parkinsonâ??s disease
- Conditions
- Health Condition 1: null- Early Parkinsonâ??s disease patients stabilized on L-dopaHealth Condition 2: G20- Parkinsons disease
- Registration Number
- CTRI/2012/08/002849
- Lead Sponsor
- Indus Biotech Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
• Age from 18 to 70 years.
• Adhered to protocol requirements as evidenced by signed informed consent.
• Patients who suffered from Parkinsonâ??s disease.
• Patients on treatment with stable dose of levodopa.
• Patients on treatment with stable dose of Dopaminergic agonists
• Refusal or inability to give informed consent
• Pregnant or lactating women.
• Participation in a clinical trial with an investigation drug within 30 days prior to day 1 of this study.
• History of hypersensitivity to the study drug or related products.
• Significant history or presence of gastrointestinal, liver or kidney, cardiac disease,
• Any other significant illness during the 4 weeks prior to day 1 of this study.
• Maintenance therapy with any drug, or history of drug dependency, alcohol abuse or apart from Parkinsonâ??s disease any serious neurological or psychological disease.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method nified Parkinsons Disease Rating Scale (UPDRS) score and its subsections viz. Mentation, Behavior and Mood, Activities of Daily Living and Motor Exam.Timepoint: At baseline and every 4 weeks till 24 weeks
- Secondary Outcome Measures
Name Time Method Clinical examination, AE monitoringTimepoint: At baseline and every 4 weeks till 24 weeks;Efficacy - Hoehn and Yahr staging, Schwab and England activities of daily living scaleTimepoint: At baseline, every 4 weeks till 24-weeks;Patientâ??s global assessment, Physicianâ??s global assessmentTimepoint: At week-24 (end of study);Safety laboratory tests (Hematology, Biochemistry, Urinalysis) and ECGTimepoint: At baseline, week-12 and week-24