Health Condition 1: null- Early Parkinsonâ??s disease patients stabilized on L-dopa Health Condition 2: G20- Parkinsons disease
Conditions
Interventions
Intervention1: IBH-B + L-Dopa: 300 mg Capsule, one capsule, twice a day for 24 weeks + Stable dose of L-Dopa
Control Intervention1: Placebo + L-Dopa: 300 mg Capsule, one capsule, twice a day for 24 we
Sponsors
Indus Biotech Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: • 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
Exclusion criteria
Exclusion criteria: • 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Unified 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
India
Contacts
Public ContactDr Prasad Thakurdesai
Indus Biotech Private Limited
Outcome results
None listed