| CTRI Number |
CTRI/2021/04/033268 [Registered on: 30/04/2021] Trial Registered Prospectively |
| Last Modified On: |
26/06/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To evaluate the effect of Snehana Karma with Atibala Taila in the management of Kampavata with special reference to Parkinsons Disease. |
|
Scientific Title of Study
|
A Clinical Study On Multimodal Snehana With Atibala Taila In The Management Of Kampavata W.S.R. To Parkinsons Disease |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Hetal Morazariya |
| Designation |
Pg Scholar |
| Affiliation |
J.S. Ayurveda Mahavidyalaya |
| Address |
JS Ayurveda Mahavidyalaya
College Road
Nadiad
Dist.Kheda
Gujarat
387001
India
JS Ayurveda Mahavidyalaya
College Road
Nadiad
Dist.Kheda
Gujarat
387001
India
Kheda
GUJARAT
387001
India |
| Phone |
8866510299 |
| Fax |
|
| Email |
hetalmorzariya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kalapi B Patel |
| Designation |
Professor |
| Affiliation |
J.S. Ayurveda Mahavidyalaya |
| Address |
JS Ayurveda Mahavidyalaya
College Road
Nadiad
Dist.Kheda
Gujarat
387001
India
JS Ayurveda Mahavidyalaya
College Road
Nadiad
Dist.Kheda
Gujarat
387001
India
Kheda
GUJARAT
387001
India |
| Phone |
9428661664 |
| Fax |
|
| Email |
drkalapi@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hetal Morazariya |
| Designation |
Pg Scholar |
| Affiliation |
J.S. Ayurveda Mahavidyalaya |
| Address |
JS Ayurveda Mahavidyalaya
College Road
Nadiad
Dist.Kheda
Gujarat
387001
India
JS Ayurveda Mahavidyalaya
College Road
Nadiad
Dist.Kheda
Gujarat
387001
India
Kheda
GUJARAT
387001
India |
| Phone |
8866510299 |
| Fax |
|
| Email |
hetalmorzariya@gmail.com |
|
|
Source of Monetary or Material Support
|
| 2. Sundar Ayurved Teaching Pharmacy, Post Graduate Department of Rasashastra evum Bhaiá¹£ajyakalpana ,J. S. Ayurveda Mahavidyalaya, Nadiad. |
|
|
Primary Sponsor
|
| Name |
JS Ayurveda Mahavidyalaya |
| Address |
J.S. Ayurveda Mahavidyalaya
College Road
Nadiad
Dist.Kheda
Gujarat
387001
India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Hetal Morazariya |
PD Patel Ayurveda Hospital |
PD Patel Ayurveda Hospital
Kaychikitsa and Panchkarma department
JS Ayurveda Mahavidyalaya
College Road
Nadiad
Kheda
Kheda
GUJARAT |
8866510299
hetalmorzariya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe For Human Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G00-G99||Diseases of the nervous system. Ayurveda Condition: Parkinsons Disease( Kampavata), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Atibala Taila |
Atibala Taila Made With Classical Reference of Ashtang Hriday Samhita is taken A.H. chi.21/73-81
Duration of treatment 25 days
Sarvanga abhyanga with Atibala Taila 30 minutes
Snehapana with Atibala Taila 20 ml twice a day
Matra basti with Atibala Taila 40 ml
Shiro basti with Atibala Taila for 45 minutes
Nasya karma with Atibala Taila 8-8 drops
|
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patients fulfilling diagnostic criteria.
Patients between the age group of 40 to 75years.
|
|
| ExclusionCriteria |
| Details |
Patients suffering from severe systemic illnesses like carcinoma, uncontrolled diabetes mellitus, tuberculosis, etc. will be excluded. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effect of Snehana karma with Atibala taila in the patient of Kampavata (Parkinsons disease) |
Effect of Snehana karma with Atibala taila for 25 days in the patient of Kampavata (Parkinsons disease) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
Final Enrollment numbers achieved (Total)= "13"
Final Enrollment numbers achieved (India)="13" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/05/2021 |
| Date of Study Completion (India) |
Date Missing |
| 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 IN A FORM OF DISSERTATION AND MAY PUBLISHED IN ANY PEER REVIEW JOURNAL WITH PRIOR PERMISSION OF GUJARAT AYURVEDA UNIVERSITY. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Parkinson’s disease is the most common progressive neurodegenerative disorder. This affects the people over the age of 55 years. Clinical features of Kampa are similar to the clinical features of Parkinson’s disease. Because Vata Prakopa is main pathological factor in Kampavata (Parkinson’s disease), the treatment which pacifies Vata Dosha can help in reducing the signs and symptoms of the disease. Taila is considered as the best among all Vata pacifying medicaments. Atibala Taila is indicated for Vata Vyadhi by Acharya Vagbhatta in Astanga Hridaya. Looking at the progressive nature of the disease, it requires long term treatment. Long term use of the drugs used in conventional medicine for Parkinson’s disease has various side effects. There is need to establish effectiveness of ayurvedic treatment which helps to control signs and symptoms of Parkinson’s disease without having any adverse effects. Hence this study is aimed to establish the effectiveness of Atibala Taila in the management of Kampavata i.e. Parkinson’s disease. |