Health Condition 1: G20- Parkinsons disease
Conditions
Interventions
Intervention1: HELICOBACTER PYLORI TREATMENT KIT: 1.Tab Pantoprazole 40 mg BID for 14 days
2.Tab Amoxicillin 750 mg BID for 14 days
3. Tab Clarithromycin 500 mg BID for 14 days
Control Intervention1
Sponsors
Jubilee Mission Medical College and Research Institute
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients diagnosed with Idiopathic Parkinson s disease by a neurologist attending the neurology outpatient department (OPD) 2.On stable levodopa therapy 3. Age -18 years to 80 years 4. Willing to provide informed consent
Exclusion criteria
Exclusion criteria: A. Parkinson s Disease Related Exclusions 1. Diagnosis of secondary parkinsonism (drug-induced, vascular, metabolic). 2. Diagnosis of Parkinson-plus syndromes (MSA, PSP, CBD, DLB). 3. Atypical features suggesting non-idiopathic PD on clinical examination. B. Medication & Testing Interference 1. Use of antibiotics effective against H. pylori (e.g., amoxicillin, clarithromycin, metronidazole, tetracycline, levofloxacin) within the past 4 6 weeks. 2. Prior H. pylori eradication therapy within the past 1 year. C. Drug Allergy or Interaction Risks 1. Known allergy or hypersensitivity to: 1.Amoxicillin / penicillin class 2.Clarithromycin / macrolides 3.PPIs (omeprazole, pantoprazole, esomeprazole) 4.Use of medications with serious interactions with clarithromycin (e.g., cisapride, pimozide, statins (atorvastatin,lovastatin,simvastatin), amiodarone, antiarrhythmics).History of QT prolongation, significant arrhythmias, or congenital long-QT syndrome. D. Co-morbid Conditions 1. Severe hepatic impairment (Child-Pugh C) or severe renal impairment (assessed using creatinine) 2. Active peptic ulcer bleeding or gastric malignancy. 3. Severe cardiac, respiratory, or uncontrolled systemic illness that may interfere with study participation. E. Physiological & Social Considerations 1. Pregnancy or lactation. 2. Women of child-bearing age not willing to use contraception during the 14-day therapy period. 3. Alcohol or substance dependence that is likely to affect adherence. 4. Cognitive impairment or psychiatric illness preventing consent or adherence. F. Logistical / Procedural Exclusions 1. Inability or refusal to provide stool samples for stool antigen testing. 2. Patients with cognitive or psychiatric impairment that will not allow patients for adherence or follow up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in motor symptoms (UPDRS-III)Timepoint: Baseline, 1 month, 3 months (primary endpoint), and 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in non motor symptoms - NMSSTimepoint: Baseline, 1 month, 3 months, 6 months;Improvement in quality of life ( PDQ-39)Timepoint: Baseline, 1 month, 3 months, 6 months;Change in Levodopa ON-OFF timeTimepoint: Baseline, 1 month, 3 months, 6 months;Sustained eradication of Helicobacter pylori ( stool antigen negative)Timepoint: 1 month and 6 months;Reduction in economic burden ( medication cost, consultation cost , travel cost , loss of workdays )Timepoint: Baseline, 3 months, 6 months, and 12-month phone follow-up | — |
Countries
India
Contacts
Public ContactDr Harisuthan T
Jubilee Mission Medical College and Research Institute
Outcome results
None listed