| CTRI Number |
CTRI/2024/10/075882 [Registered on: 25/10/2024] Trial Registered Prospectively |
| Last Modified On: |
19/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [RANDOMIZED COMPARATIVE STUDY] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Ayurvedic Treatment of Kampavata |
|
Scientific Title of Study
|
A Clinico comparative Study of Atibala Taila And Narayana Taila As Multimodal Snehana In The Management of Kampavata 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 Kairavi S Trivedi |
| Designation |
PhD Scholar |
| Affiliation |
J S Ayurveda Mahavidyalaya Nadiad |
| Address |
P.G. Department of Panchakarma, P. D Patel ayurvedic hospital College road
P.G. Department of Panchakarma, P. D Patel ayurvedic hospital College road
Kheda
GUJARAT
387001
India |
| Phone |
08849822501 |
| Fax |
|
| Email |
trivedikairavi91@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
PROF DR KALAPI B PATEL |
| Designation |
HEAD OF DEPARTMENT PANCHAKARMA |
| Affiliation |
J S Ayurveda Mahavidyalaya Nadiad |
| Address |
POST GRADUATE DEPARTMENT OF PANCHAKARMA, ROOM NO 135, J S AYURVEDA MAHAVIDYALAYA
POST GRADUATE DEPARTMENT OF PANCHAKARMA, ROOM NO 135, J S AYURVEDA MAHAVIDYALAYA
Kheda
GUJARAT
387001
India |
| Phone |
9428661664 |
| Fax |
|
| Email |
drkalapi@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kairavi S Trivedi |
| Designation |
PhD Scholar |
| Affiliation |
J S Ayurveda Mahavidyalaya Nadiad |
| Address |
Panchakarma Department, J.S. Ayurveda Mahavidyalaya, P. D Patel ayurvedic hospital College road
Panchakarma Department, J.S. Ayurveda Mahavidyalaya, P. D Patel ayurvedic hospital College road
Kheda
GUJARAT
387001
India |
| Phone |
08849822501 |
| Fax |
|
| Email |
trivedikairavi91@gmail.com |
|
|
Source of Monetary or Material Support
|
| SUNDAR AYURVEDA TEACHING PHARMACY, P.D.Patel Ayurveda Hospital, J S AYURVEDA MAHAVIDYALAYA COLLEGE ROAD NADIAD |
|
|
Primary Sponsor
|
| Name |
J S Ayurveda Mahavidyalaya P DPatel Ayurveda Hospital |
| Address |
J S AYURVEDA MAHAVIDYALAYA COLLEGE ROAD NADIAD GUJARAT 387001 |
| Type of Sponsor |
Private medical college |
|
|
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 KAIRAVI TRIVEDI |
P D PATEL AYURVEDA HOSPITAL & J S AYURVEDA MAHAVIDYALAYA |
POST GRADUATE DEPARTMENT OF PANCHAKARMA P D PATEL AYURVEDA HOSPITAL J S AYURVEDA MAHAVIDYALAYA COLLEGE ROAD NADIAD
Kheda
GUJARAT |
8849822501
trivedikairavi91@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee for human research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition:G20||Parkinsons disease. Ayurveda Condition: PARKINSONS DISEASE, (2) ICD-10 Condition:G20||Parkinsons disease. Ayurveda Condition: VATAVYADHIH, (3) ICD-10 Condition:G20||Parkinsons disease. Ayurveda Condition: VATAVYADHIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: ATIBALA TAILA, Reference: ASHTANG HRIDAYA, Route: Oral, Dosage Form: Taila, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 4 Weeks, anupAna/sahapAna: Yes(details: USHNODAKA), Additional Information: PATIENT WILL BE GIVEN MULTIMODAL SNEHANA WITH ATIBALATAILA ORALLY 20 ML TWICE A DAY ALSO IN ABHYANAGA 100 ML
ONE TIME IN SHIROBASTI 200 ML
IN MATRA BASTI 40 ML
IN NASYA 8 ML | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: NARAYANA TAILA, Reference: BHAISHAJYA RATNAVALI, Route: Oral, Dosage Form: Taila, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 4 Weeks, anupAna/sahapAna: Yes(details: USHNODAKA), Additional Information: PATIENT WILL BE GIVEN MULTIMODAL SNEHANA WITH NARAYANA ORALLY 20 ML TWICE A DAY ALSO IN ABHYANAGA 100 ML ONE TIME IN SHIROBASTI 200 ML IN MATRA BASTI 40 ML IN NASYA 8 ML
|
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patients will be clinically diagnosed with following signs & symptoms of Kampavata (Parkinson’s disease)
Tremor
Rigidity
Postural imbalamce
Bradykinesia / Akinesia
Mask face
Patients fulfilling diagnostic criteria.
Patients between the age group of 40-75 yrs.
|
|
| ExclusionCriteria |
| Details |
Patients suffering from severe systemic illnesses like,
Uncontrolled diabetes mellitus
Tuberculosis
Carcinoma etc |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| EFFECT OF AYURVEDIC MANAGEMENTIN THE PATIENTS OF KAMPAVATA |
4 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| CHANGES IN THE SIGN AND SYMPTOMS OF THE DISEASE PATENTS |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
10/11/2024 |
| Date of Study Completion (India) |
24/09/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
This will be submitted as a form of dissertation and may published in any peer reviewed journal with the permission of Magan bhai Adenwala Mahagujarat University |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
ATIBALA TAILA AND NARAYAN TAILA WILL BE ADMINISTERED THROUGH MULTIPLE ROUTE AS DIFFERENT SNEHANA METHODS AS NASYA, MATRA BASTI , ABHYANGA, SHIROBASTI AND ABHYANTARA SHAMANARTH SNEHAPANA IN PRESENT STUDY ATIBALA TAILA IN GROUP A AND NARAYANA TAILA IN GROUP B WILL BE TAKEN FOR ALL THESE TREATMENTS AND PROCEDURES
|