A clinical trial to know the advantage of add-on Ayurveda treatment versus Allopathy treatment in Parkinsons disease

Ayurveda therapeutic regimen as on Add-on to optimized conventional management of Parkinsonâ??s disease: An RCT for assessment of Clinical Cortical excitability Neuroimmune and Autonomic function parameters

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/01/039803

Enrollment

Registered

2022-01-28

Start date

Unknown

Completion date

Unknown

Last updated

2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: G20- Parkinsons disease

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients fulfilling UKPDSBB criteria. 2. Patients aged 40 years to 70 years. 3. Patients with H&Y staging between 2.5 to 4 4. Patients with chronicity more than 5 years 5. Patients not optimally responding to standard treatment. 6. Patients ready to provide informed consent

Exclusion criteria

Exclusion criteria: 1. Patients with other parkinsonism spectra 2. Other neurodegenerative disorders 3. Patients with hepatic dysfunction 4. Patients with severe renal dysfunction 5. Patients with Severe pulmonary dysfunction 6. Patients with severe cardiac dysfunction 7. Cognitive impairment MMSE less than 12 8. Patients with evidence of malignancy 9. Patients with Substance abuse 10. Patients who completed participation in any other trial during past 6 months

Design outcomes

Primary

Measure	Time frame
Changes in sum of the MDS-UPDRS scoreTimepoint: 6 Months	—

Secondary

Measure	Time frame
1. Changes in cortical excitability through Single and paired pulse Transcranial magnetic stimulation measures. 2. Changes in Heart Rate Variability 3. Changes in Pulmonary function tests 4. Changes in Th1/Th2/Th17/T regulatory cell population, plasma levels of pro-inflammatory cytokines 5. Changes in Telomere Length 6. Changes in Unified Dyskinesia Rating Scale (UDysRS). 7. Changes in Montreal Cognitive Assessment (MoCA). 8. Changes in Mini BESTest (Balance Evaluation Systems Test) 9. Changes in gait assessed through 6-minute walk test and gait speed (10-meter walk test) 10. Changes in Epworth Sleepiness Scale (ESS)Timepoint: 6 Months	—

Measure

Time frame

1. Changes in cortical excitability through Single and paired pulse Transcranial magnetic stimulation measures. 2. Changes in Heart Rate Variability 3. Changes in Pulmonary function tests 4. Changes in Th1/Th2/Th17/T regulatory cell population, plasma levels of pro-inflammatory cytokines 5. Changes in Telomere Length 6. Changes in Unified Dyskinesia Rating Scale (UDysRS). 7. Changes in Montreal Cognitive Assessment (MoCA). 8. Changes in Mini BESTest (Balance Evaluation Systems Test) 9. Changes in gait assessed through 6-minute walk test and gait speed (10-meter walk test) 10. Changes in Epworth Sleepiness Scale (ESS)Timepoint: 6 Months

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Countries

India

Contacts

Public ContactDr Umesh C

National Institute of Mental Health and Neurosciences

drumeshayu@gmail.com7975856612

Outcome results