| CTRI Number |
CTRI/2025/11/097626 [Registered on: 18/11/2025] Trial Registered Prospectively |
| Last Modified On: |
12/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study regarding role of a Ayurveda medicine in Parkinsons Disease. |
|
Scientific Title of Study
|
Clinical Evaluation of Varuni Tailam with DashmoolKwath and Varuni Tailam Nasya in the Management of kamanvata with special reference to Parkinsons Disease |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sanandan Thapliyal |
| Designation |
Professor and Head, Department of Kayachikitsa |
| Affiliation |
Shivalik Institute of Ayurveda and Research Dehradun |
| Address |
Room No. 25, 1st Floor, Academic Block,
Department of Kayachikitsa,
Shivalik Institute of Ayurveda and Research
Bansiwala, Jhajra, Chakrata Road, Dehradun 248007, Uttarakhand
Dehradun
UTTARANCHAL
248007
India |
| Phone |
9105000810 |
| Fax |
|
| Email |
sanandanthapliyal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Vd Rakesh Sharma |
| Designation |
Professor |
| Affiliation |
Guru Ravidas Ayurveda University |
| Address |
Room No. 01, 2nd Floor,
PhD Section,
Board of Ayurvedic and Unani System of Medicine, Punjab
Medical education Bhawan
Sector 69, Mohali, Punjab
Rupnagar
PUNJAB
160062
India |
| Phone |
9814779242 |
| Fax |
|
| Email |
vaidyaras03@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Vd Rakesh Sharma |
| Designation |
Professor |
| Affiliation |
Guru Ravidas Ayurveda University |
| Address |
Room No. 01, 2nd Floor,
PhD Section,
Board of Ayurvedic and Unani System of Medicine, Punjab
Medical education Bhawan
Sector 69, Mohali, Punjab
Rupnagar
PUNJAB
160062
India |
| Phone |
9814779242 |
| Fax |
|
| Email |
vaidyaras03@gmail.com |
|
|
Source of Monetary or Material Support
|
|
Shvalik Hospital
Shivalik Institute of Ayurveda and Research,
Jhajra, Chakrata Road, Dehradun 248007, Uttarakhand |
|
|
Primary Sponsor
|
| Name |
Dr Sanandan Thapliyal |
| Address |
Shivalik Institute of Ayurveda and Research
Bansiwala, Jhajra, Chakrata Road, Dehradun |
| Type of Sponsor |
Other [Ayurveda Teaching Institute] |
|
|
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 Sanandan Thapliyal |
Kayachikitsa OPD, Ground Floor, Shivalik Hospital, Shivalik Institute of Ayurveda and Research |
Jhajra Chakrata Road Dehradun 248007
Dehradun
UTTARANCHAL |
8126706510
sanandanthapliyal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee GRAUP |
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 (KEVALAVATA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Varuni Tail, Reference: Sharangdhar Samhita, Route: Oral, Dosage Form: Taila, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: Dashmool Kwath), Additional Information: 10 ml Varuni tail with 20 ml Dashmool Kawth and Varuni tail nasya | | 2 | Comparator Arm (Non Ayurveda) | | - | L-Dopa | L-Dopa (levodopa) 100mg BID |
|
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients willing to participate and provide written consent.
Patients exhibiting the features of Kampavatas
Age 50 to 80 yr of either sex
Both freshly detected and already diagnosed cases
|
|
| ExclusionCriteria |
| Details |
Patients with systemic disorders and with other complication.
History of repeated strokes with stepwise progression of Parkinson’s disease.
History of head injury.
History of definite encephalitis and early severe dementia
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in Tremors, Rigidity and Bradykinesia |
8 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in Symptoms Grading
(As per WHO scoring of Ayurveda Symptoms, IPGTRA, Jamnagar, 2011 guidelines) of Kampa (Tremor), Stambha (Rigidity) and Asamyakgati (Bradykinesia/Impaired mobility).
|
8 week |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 2 |
|
Date of First Enrollment (India)
|
01/01/2026 |
| 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="0"
Months="2"
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
|
This study is a randomized, double blind, parallel group trial to evaluate clinical efficacy of Varuni Tailam with Dashmool Kwath and Varuni tailam nasya in the the patients of Kampvata with special reference to Parkinson’s disease. It will have two groups (30 patients in each group) with Group 1 – Varuni Tailam 10 ml with Dashmool Kwath 20ml and Varuni Tailam Nasya (2drops/nostril), Group 2 – Tablet Ldopa 100mg daily, duration will be 8 weeks. Primary outcome being improvement in Unified Parkinson’s Disease Rating Scale (UPDRS) and secondary outcome - Improvement in Ayurveda Symptoms grading of (Kampa /Tremor, Stambha /Rigidity and Asamyakgati /Bradykinesia) as per WHO scoring of Ayurveda Symptoms, IPGTRA, Jamnagar, 2011 Guidelines. |