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CTRI Number  CTRI/2022/01/039803 [Registered on: 28/01/2022] Trial Registered Prospectively
Last Modified On: 05/09/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical trial to know the advantage of add-on Ayurveda treatment versus Allopathy treatment in Parkinsons disease 
Scientific Title of Study   Ayurveda therapeutic regimen as on Add-on to optimized conventional management of Parkinson’s disease: An RCT for assessment of Clinical Cortical excitability Neuroimmune and Autonomic function parameters 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Umesh C 
Designation  Scientist - C (Ayurveda) 
Affiliation  National Institute of Mental Health and Neurosciences 
Address  Department of Integrative Medicine National Institute of Mental Health and Neurosciences Hosur Road Bengaluru

Bangalore
KARNATAKA
560029
India 
Phone  7975856612  
Fax    
Email  drumeshayu@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Umesh C 
Designation  Scientist - C (Ayurveda) 
Affiliation  National Institute of Mental Health and Neurosciences 
Address  Department of Integrative Medicine National Institute of Mental Health and Neurosciences Hosur Road Bengaluru

Bangalore
KARNATAKA
560029
India 
Phone  7975856612  
Fax    
Email  drumeshayu@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Umesh C 
Designation  Scientist - C (Ayurveda) 
Affiliation  National Institute of Mental Health and Neurosciences 
Address  Department of Integrative Medicine National Institute of Mental Health and Neurosciences Hosur Road Bengaluru

Bangalore
KARNATAKA
560029
India 
Phone  7975856612  
Fax    
Email  drumeshayu@gmail.com  
 
Source of Monetary or Material Support  
Central Council for Research in Ayurvedic Sciences Jawahar Lal Nehru Bhartiya Chikitsa Avum Homeopathy Anusandhan Bhavan No.61-65, Institutional Area, Opp. D Block, Janakpuri, New Delhi - 110058 ( India ) 
 
Primary Sponsor  
Name  Central Council for Research in Ayurvedic Sciences 
Address  Ministry of AYUSH, Government of India 61-65, Institutional Area, Opposite “D” Block, Janakpuri, New Delhi - 110058 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Umesh C  National Institute of Mental Health and Neurosciences  Department of Neurology and Department of Integrative Medicine NIMHANS, Hosur Main Road, Bengaluru 560029
Bangalore
KARNATAKA 		 7975856612

drumeshayu@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Human Ethics Committee for Research in AYUSH and Integrative Medicine  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:G20||Parkinsons disease. Ayurveda Condition: KAMPAH/VEPATHUH (KEVALAVATA),  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator Arm (Non Ayurveda)-Conventional TreatmentTab Levodopa and carbidopa 125 mg or Tab Levodopa and Carbidopa 250 mg or Tab Pramipexole 1 mg or Tab Ropinirole 2 mg or Tab Amantadine 100 mg or Tab Entacapone 200 mg or Tab Rasagiline 1 mg or Tab Selegiline 5 mg
2Intervention ArmDrugClassical(1) Medicine Name: Mashabaladi Kvatha, Reference: Ayurveda Formulary of India , Route: Oral, Dosage Form: Taila, Dose: 15(ml), Frequency: tds, Bhaishajya Kal: 141 Days, Duration: , anupAna/sahapAna: No, Additional Information:
(2) Medicine Name: Chitrakadi Vati, Reference: Ayurveda Pharmacopeia of India , Route: Oral, Dosage Form: Taila, Dose: 250(mg), Frequency: tds, Bhaishajya Kal: 15 Days, Duration: , anupAna/sahapAna: No, Additional Information:
(3) Medicine Name: Kalyanaka Gritha, Reference: Ayurveda Pharmacopeia of India, Route: Oral, Dosage Form: Taila, Dose: 20(ml), Frequency: od, Bhaishajya Kal: 141 Days, Duration: , anupAna/sahapAna: No, Additional Information:
3Intervention ArmProcedure-bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म (Procedure Reference: Vatavyadhi Charaka Samitha, Procedure details: Abhyanga sveda will be conducted over the abdominal region. The patient will be made to lie in the left lateral position. With the advice of deep inspiration and expiration to the patient rubber catheter will be slowly inserted into the anal orifice up to 8 centimetres and Basti will be administered slowly.)
(1) Medicine Name: Erandamoola Basti, Reference: Siddhi Sthana Charaka Samhita, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 450(ml), Frequency: od, Duration: 3 Days
4Intervention ArmProcedure-bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म (Procedure Reference: Vatavyadhi Charaka Samhita, Procedure details: Abhyanga sveda will be conducted over the abdominal region. The patient will be made to lie in the left lateral position. With the advice of deep inspiration and expiration to the patient rubber catheter will be slowly inserted into the anal orifice up to 8 centimeters and Basti will be administered slowly.)
(1) Medicine Name: Bala Taila, Reference: Ayurveda Pharmacopeia of India , Route: Rectal, Dosage Form: Taila, Dose: 80(ml), Frequency: od, Duration: 5 Days
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  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
 
 
ExclusionCriteria 
Details  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 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Changes in sum of the MDS-UPDRS score   6 Months 
 
Secondary Outcome  
Outcome  TimePoints 
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)  		 6 Months 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   03/02/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Not Yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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

 
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