Health Condition 1: G20- Parkinsons disease
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients aged 50-80 years 2. Both genders 3. The diagnosis of PD as established using the UK Parkinsons Disease Society Brain Bank Clinical diagnostic criteria or Any of the four common types of Parkinson plus Syndrome diagnosed by a neurologist as per the following Criteria Multiple System atrophy- Movement disorder society criteria Progressive Supranuclear Palsy (PSP)- NINDS and Society for PSP criteria Cortical Basal Degeneration (CBD)- New consensus criteria of Armstrong for diagnosis of CBD Dementia with Lewy bodies- Revised Consensus criteria for diagnosis of DLB 2017 4. Parkinsons Disease severity of 1 to 3 according to the modified Hoehn & Yahr scale 5. Participants with other comorbidities such as controlled diabetes, controlled hypertension 6. Participants with other comorbidities that seem fit as per the treating physician 7. Participants are willing to give written informed consent.
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria will be excluded from participating in the study: Patients suffering from any mental health problems: schizophrenia, bipolar affective disorder, or other psychotic illnesses. Life-threatening illnesses, malignant tumors, HIV. Parkinson s disease with severity 4 as per the modified Hoehn & Yahr scale. Concurrent severe and/or uncontrolled and/or unstable other medical disease that, in the opinion of the Investigator, may significantly interfere with study compliance. Inability to comply with the study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess if homeopathy has added benefits in the treatment of patients with Parkinson s disease and Parkinson-plus syndrome during 12 months of treatment as assessed using the MDS-UPDRS questionnaire in the two groups. To evaluate the progression of supranuclear palsy using the PSPRS for Parkinson plus syndrome during 12 months of treatment in the two groups. Timepoint: Baseline, month 6, & month 12 in the two groups | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of the effect of homeopathy on health-related quality of life (HRQoL) using PDQ-39Timepoint: Baseline, month 6, & month 12 in the two groups;Assessment of the Functional status by the Mini-Mental State Examination (MMSE), in Parkinson disease with mild cognitive impairment: MMSE score,Parkinson disease with dementia: MMSE score,Parkinson disease with normal cognition: MMSE scoreTimepoint: Baseline, month 6, & month 12 in the two groups;Assessment of the Serum Biomarker by alpha-synuclein at Baseline, month 6, & month 12 in the two groups.Timepoint: Baseline, month 6, & month 12 in the two groups;Assessment of the brain activity abnormalities in Parkinson s disease (PD) by EEGTimepoint: Baseline, month 6, & month 12 in the two groups;Changes in blood parameters like CBC, LFT, KFT, sugar profile (HbA1C), or as suggested by the investigator depending upon the Co-morbidity suffered by the patientTimepoint: Baseline, month 3, 6, 9 & month 12 in the two groups;Reduction of standard care medication in the two groups Timepoint: Baseline, month 6, & month 12 in the two groups | — |
Countries
India
Contacts
Chettinad Hospital and Research Institute, Chettinad Academy of Research and Education