| CTRI Number |
CTRI/2018/03/012480 [Registered on: 12/03/2018] Trial Registered Prospectively |
| Last Modified On: |
09/03/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative Study of Two different type of Ayurvedic Treatment in knee joint pain |
|
Scientific Title of Study
|
A Clinico-Comparative study of Nirgundi Patra Pinda Sweda & Janu Basti with Narayan Taila in the Management of Janu-Sandhigata Vata(Knee-Osteoarthritis) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anupriya R Gamit |
| Designation |
PG scholar |
| Affiliation |
J S Ayurveda Mahavidyalay |
| Address |
J S Ayurveda Mahavidyalay, Panchkarma Department,Collge road, Nadiad
J S Ayurveda Mahavidyalay, college road, Nadiad-387001, Gujarat.
Kheda
GUJARAT
387001
India |
| Phone |
8200046140 |
| Fax |
|
| Email |
preeya005@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nayan Joshi |
| Designation |
Professor |
| Affiliation |
J S Ayurveda Mahavidyalay |
| Address |
J S Ayurveda Mahavidyalay, Panchkarma Department, College road, Nadiad.
Kheda
GUJARAT
387001
India |
| Phone |
9825426885 |
| Fax |
|
| Email |
nayanjoshi_2005@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nayan Joshi |
| Designation |
Professor |
| Affiliation |
J S Ayurveda Mahavidyalay |
| Address |
J S Ayurveda Mahavidyalay, Panchkarma Department,College road, Nadiad.
Kheda
GUJARAT
387001
India |
| Phone |
9825426885 |
| Fax |
|
| Email |
nayanjoshi_2005@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Sundar Ayurvedic Pharmacy, J S Ayurveda college, college road,Nadiad- 387001. |
|
|
Primary Sponsor
|
| Name |
J S Ayurveda college |
| Address |
J S Ayurveda college, college road, Nadiad-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 |
| Anupriya R Gamit |
P D Patel Ayurveda Hospital |
Panchkarma Department,P D Patel Ayurveda Hospital, college road, Nadiad-387001.
Kheda
GUJARAT |
8200046140
preeya005@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee for Human Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Osteoarthritis patients, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ayurvedic classical procedure |
Janubasti with Narayan taila on affected knee joint for 15 days externally
Route- External application |
| Comparator Agent |
Ayurvedic classical procedure |
Nirgundi Patra Pinda Sweda with narayan taila on the affected joint for 15 days externally
route- external application |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. patients having signs and symptoms of Sandhigata vata of janusandhi like sandhi sopha, sandhi Vedana
|
|
| ExclusionCriteria |
| Details |
patient suffering from any chronic diseases like Tuberculosis, Diabetes mellitus, rheumatoid arthritis,gout etc. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of two Ayurvedic Management in two different groups of patients Osteoarthritis |
analysis after treatment and after 28 days of treatment ,Comparison of two Ayurvedic Management in two different groups of patients of Osteoarthritis |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
12/03/2018 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not applicable this thesis work will yet to be submit |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
comparative clinical evaluation of the effectiveness of Janubasti and Nirgundi patra pinda sweda with Narayan taila management of knee joint osteoarthriris is the main objective of the study. patient will be selected from p d patel ayurveda hospital, nadiad after the confirmation of the diagnosis of osteo arthritis with the help of positive classical signs and symptoms as well as other laboratory investigations. there are 2 groups in this study. patients of group A will be treated with janu basti with narayan taila for 15 days externally on affected joint. patients of group B will be given Nirgundi patra pinda sweda with narayan taila externally for 15 days on affected joint. Assessment will be done on the basis of improvement in signs and symptoms as well as improvement in WOMAC scale. Results will be analysed with paired t test and spear men co-relation test. |