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

Phase 4

Not yet recruiting

• Conditions: Parkinsons disease. Ayurveda Condition: KAMPAH/VEPATHUHÂ (KEVALAVATA),

• Registration Number: CTRI/2022/01/039803
• Lead Sponsor: Central Council for Research in Ayurvedic Sciences

Brief Summary

This study is a randomized single-blind, parallel-group trial comparing the safety and efficacy of Add-on Ayurveda intervention (Yoga Basti with Erandamoola Kashaya and Bala Taila for 8 days, Mashabaladi Kvatha, Kalyanaka Gritha for 47 days, and Chitrakadi vati for 5 days every two months for a duration of 6 Months) and Conventional treatment (Levodopa and carbidopa/ Pramipexole/ Ropinirole/ Amantadine/ Entacapone, Rasagiline/ Selegiline) daily for six months in 160 subjects (80 in each group) with Parkinson’s Disease (PD) that will be conducted at National Institute of Mental health and Neurosciences (NIMHANS) Bengaluru. The primary outcome measure will be Changes in the sum of the MDS-UPDRS score at six months. The secondary outcome measures are - Changes in cortical excitability through Single and paired-pulse Transcranial magnetic stimulation measures, Heart Rate Variability, Pulmonary function tests, Th1/Th2/Th17/T regulatory cell population, plasma levels of pro-inflammatory cytokines, Telomere Length, Unified Dyskinesia Rating Scale (UDysRS), Montreal Cognitive Assessment (MoCA), Mini BESTest (Balance Evaluation Systems Test), Gait assessed through 6-minute walk test and gait speed (10-meter walk test), Epworth Sleepiness Scale (ESS) and Safety of Ayurveda interventions at six months

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-02
• Last Update Posted: 2024-09-01

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Patients fulfilling UKPDSBB criteria.
• Patients aged 40 years to 70 years.
• 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.

Exclusion Criteria

• Patients with other parkinsonism spectra 2.
• Other neurodegenerative disorders 3.
• Patients with severe renal dysfunction 5.
• Patients with Severe pulmonary dysfunction 6.
• Patients with evidence of malignancy 9.
• Patients with Substance abuse 10.
• Patients who completed participation in any other trial during past 6 months.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in sum of the MDS-UPDRS score	6 Months

Secondary Outcome Measures

Name	Time	Method
1. Changes in cortical excitability through Single and paired pulse Transcranial magnetic stimulation measures.	2. Changes in Heart Rate Variability

Trial Locations

Locations (1)

National Institute of Mental Health and Neurosciences; 🇮🇳 Bangalore, KARNATAKA, India

National Institute of Mental Health and Neurosciences

🇮🇳Bangalore, KARNATAKA, India

Dr Umesh C

Principal investigator

7975856612

drumeshayu@gmail.com