| CTRI Number |
CTRI/2021/03/031962 [Registered on: 12/03/2021] Trial Registered Prospectively |
| Last Modified On: |
12/03/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the effect of punarnava taila and kethakyadi taila parisheka in patients with sandhigata vata oa knee. |
|
Scientific Title of Study
|
“A randomized controlled clinical trial on punarnava taila parisheka sveda in sandhighata vata. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Amrutha C |
| Designation |
MD scholar |
| Affiliation |
Alvas ayurveda medical college and hospital |
| Address |
Alvas Ayurveda medical college and hospital, Vidyagiri Moodbidri,D.K.district, Karnataka
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9497185714 |
| Fax |
|
| Email |
93amruthac@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Praveen B S |
| Designation |
Professor and HOD |
| Affiliation |
Alvas ayurveda medical college and hospital |
| Address |
Alvas Ayurveda medical college and hospital, Vidyagiri, Moodbidri,D.K.district, Karnataka
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9964006795 |
| Fax |
|
| Email |
praveenbs76@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amrutha C |
| Designation |
MD scholar |
| Affiliation |
Alvas ayurveda medical college and hospital |
| Address |
Department of Panchakarma, Alvas Ayurveda medical college and hospital, Vidyagiri, Moodbidri,D.K.district, Karnataka
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9497185714 |
| Fax |
|
| Email |
93amruthac@gmail.com |
|
|
Source of Monetary or Material Support
|
| Alvas Ayurveda medical college and hospitals, vidyagiri, moodbidri, DK district, Karnataka 5 |
|
|
Primary Sponsor
|
| Name |
M Chenthamarakshan |
| Address |
surya sumam, ega 23, evergreen avenue, kunnathurmedu, Palakkad,kerala 678013 |
| Type of Sponsor |
Other [Father] |
|
|
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 Amrutha C |
Alvas ayurveda medical college and hospital |
Room no 201, 2nd floor
Demo room,department of panchakarma.
Dakshina Kannada
KARNATAKA |
9497185714
93amruthac@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional clinical ethics committee a;vas ayurveda medical college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Kethakyadi Taila Parisheka Sveda |
Each patient will be subjected to sthanika abhyanga for 5 minutes with kethakyadi taila followed by sthanika parisheka sveda on knee with 5ltr kethakyadi taila for 50minutes once a day for 7days.follow up is done on 14th 28th 42nd 56th day after trial. |
| Intervention |
Punarnava Taila Parisheka Sveda |
Each patient will be subjected to sthanika abhyanga for 5 minutes with punarnava taila followed by sthanika parisheka sveda on knee with approx 5ltr punarnava taila for 50minutes once a day for 7days.follow up will be done on 14th 28th 42nd 56th day after treatment. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients fulfilling the diagnostic criteria
Patients between 30 to 65 years will be considered.
Patients who are fit for Parisheka Sweda.
X-Ray changes in Osteoarthritis
|
|
| ExclusionCriteria |
| Details |
Patients having Rheumatoid Arthritis, Gouty Arthritis
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
the symptoms like pain, stiffness,physical function will be evaluated based on modified WOMAC SCORE (CRD Pune Version)
objective criteria including swelling, crepitus, tenderness, range of motion will be assessed with universal goniometer. |
2months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not applicable |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
15/03/2021 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a randomised controlled clinical trial on efficacy of punarnava taila and kethakyadi taila parisheka sveda in sandhigata vata daily for 7days in 40days that will be conducted in alvas Ayurveda medical college Vidyagiri Moodbidri Dakshina Kannada India .Primary outcome measure will be pain, swelling, crepitus, tenderness, range of motion in 2months. |