| CTRI Number |
CTRI/2026/01/102344 [Registered on: 28/01/2026] Trial Registered Prospectively |
| Last Modified On: |
23/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Ayurveda Interventions in Parkinsons disease |
|
Scientific Title of Study
|
Evaluation of Clinical effectiveness of Ayurveda Multi-Modal
Treatment(CCRAS-Park) in Parkinsons disease: an exploratory Pilot Trial |
| Trial Acronym |
CCRAS PARK |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Devi R Nair |
| Designation |
Research Officer (Ay) |
| Affiliation |
National Ayurveda Research Institute for Panchakarma Cheruthuruthy |
| Address |
Technical cadre Hospital Division National Ayurveda Research Institute for Panchakarma Cheruthuruthy Thrissur Kerala
Technical cadre Hospital Division National Ayurveda Research Institute for Panchakarma Cheruthuruthy Thrissur Kerala
Thrissur
KERALA
679531
India |
| Phone |
09074298620 |
| Fax |
|
| Email |
drdevinair87@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Devi R Nair |
| Designation |
Research Officer (Ay) |
| Affiliation |
National Ayurveda Research Institute for Panchakarma Cheruthuruthy |
| Address |
Technical cadre Hospital division National Ayurveda Research Institute for Panchakarma Cheruthuruthy Thrissur Kerala
Thrissur
KERALA
679531
India |
| Phone |
09074298620 |
| Fax |
|
| Email |
drdevinair87@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Devi R Nair |
| Designation |
Research Officer (Ay) |
| Affiliation |
National Ayurveda Research Institute for Panchakarma Cheruthuruthy |
| Address |
Technical cadre Hospital division National Ayurveda Research Institute for Panchakarma Cheruthuruthy Thrissur Kerala
Thrissur
KERALA
679531
India |
| Phone |
09074298620 |
| Fax |
|
| Email |
drdevinair87@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Ayurveda Sciences, Ministry of Ayush, Govt of India, New Delhi, Delhi 110058, India |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Ayurvedic Sciences |
| Address |
New Delhi,Delhi 110058,India |
| Type of Sponsor |
Other [Autonomous body for research in India] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr DEVI R NAIR |
National Ayurveda Research Institute for Panchakarma Cheruthuruthy |
National Ayurveda Research Institute for Panchakarma, Cheruthuruthy, Kerala-679531 Technical cadre Hospital division
Thrissur
KERALA |
09074298620
drdevinair87@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe, NARIP, Cheruthuruthy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G20||Parkinsons disease. Ayurveda Condition: KAMPAH/VEPATHUH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | Panchakarma protocol | (Procedure Reference: Brhat trayi, Procedure details: Churna pinda sweda for 7 days
Abhyanga with nadi sweda for 7 days
Yogavasti protocol 8th to 15th day
Marsa nasya karma 16th to 22nd day
Karnapoorana 8th to 28th day
Gandusha 8th to 28th day
Padabhyanga 8th to 28th day
Sirodhara 23rd to 29th day
Deepana pachana and samana snehapan a intermittently upto 180th day)
(1) Medicine Name: Vaiswanara churna, Reference: API, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Duration: 50 Days(2) Medicine Name: kalyanaka ghee, Reference: API, Route: Oral, Dosage Form: Ghrita, Dose: 10(ml), Frequency: hs, Duration: 50 Days |
|
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Participants who are diagnosed with PD of greater than 2year duration and are non-ambulatory.
Patients those who are relatively stable during the study period and remained stable on medication in the last 2 months.
Willing to comply and provide written informed consent, for intervention treatment
Participants receiving dopaminergic medications will be asked to continue the same up to completion of study (6 months)
|
|
| ExclusionCriteria |
| Details |
Prior diagnosis of dementia or mild cognitive impairment on screening MOCA 24, other psychiatric symptoms
History of co morbid neurologic disorders or major cardiovascular conditions, history of deep brain stimulation or other brain surgery, neurogenic orthostatic hypotension, clinically diagnosed chronic respiratory illness, liver disease, renal disease, uncontrolled hypertension, pregnancy
Any other condition that the investigator believes makes him or her unsuitable for participation in this study
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| UPDRS scale, Freezing of gait questionnaire - I(FOG-Q), Falls efficacy scale, gait evaluation parameters like Velocity (cm/sec), Average step length (cm), Average stance time (s) |
base line, day 30, day 60, day 90, day 120, day 180 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate changes in cognitive outcome parameters using Parkinson’s Disease Cognitive Functional Rating Scale (PD-CFRS) and Montreal Cognitive Assessment Scale (MoCA) |
Day 1,30th day, 60th day, 90th day,120th day and 180th day |
| Proportion of participants demonstrating a reduction in the dose of dopaminergic medication or prevention of dose escalation, assessed on the 90th day and 180th day, compared to baseline medication status. |
90th day, 180th day |
| To assess the adverse events reported by CCRAS Park protocol |
1-30th day, 60th day, 90th day, 120th day,180th day. |
| Tolerability of CCRAS-park protocol measured from treatment adherence table in case record form |
Day 30, 60, 90, 120 and 180. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 3 |
|
Date of First Enrollment (India)
|
01/04/2026 |
| 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)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The
aim of the present study is to evaluate a scientifically designed Ayurveda
procedure protocol(CCRAS-Park) targeted to give deep brain stimulation and
stimulation to vagal nerve fibres. The procedures hypothesized for stimulation
of vagus nerve is postulated in the design to give vagal nerve stimulation and
deep brain stimulation due to temperature, pressure, retention effects over a
period of time activating stimulatory pathways. The procedures typically serve
in stimulating vagal nerve sites are totally safe and with no complications
since they are included in the daily regimen and life style advocacies in
Ayurveda Preventive medicine. This protocol is hypothesized to give more
sustainable results, improved QOL, patient-friendliness, cost-effectiveness
compared to existing treatment strategies of DBS, VNS and nVNS. Being the most
preliminary step, this exploratory pilot protocol, will open up new vistas in
Ayurveda parkinsonism research and will contribute to sustainable therapeutic
outcomes with no complications. Patient
screening will be done from NARIP, Cheruthuruthy from General daily OPD. Also,
Parkinson’s screening camps will be conducted at NARIP frequent basis. The
enrolled participants will undergo stabilization of levodopa at Jubilee Mission
Medical College Hospital in day 0. The participants will undergo CCRAS-Park
protocol at the IPD of NARIP, Cheruthuruthy for 30 days followed by a follow up
period upto 180th day. The follow up visits will be done at 30th
day, 60th day, 90th day and 180th day. |