| CTRI Number |
CTRI/2021/03/031912 [Registered on: 11/03/2021] Trial Registered Prospectively |
| Last Modified On: |
09/03/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical trial to see the effect of Tila Upanaha in patient suffering from joint pain. |
|
Scientific Title of Study
|
A Randomized controlled clinical study on Tila Upanaha in the management of sandhigatavata. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Dharshana Krishnan O |
| Designation |
PG Scholar |
| Affiliation |
Alvas Ayurveda Medical College and Hospital |
| Address |
Dr Dharshana Krishnan O
PG Scholar
Department of PG studies in Panchakarma Alvas Ayurveda Medical College and Hospital Moodbidri
Dakshina Kannada District
Alvas Ayurveda Medical College
Vidyagiri Moodbidri
Dakshina Kannada District
Karnataka
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
8078471793 |
| Fax |
|
| Email |
dharshanakrishnano@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 |
Dr Praveen B S
Professor and HOD
Department Of PG studies in Panchakarma Alvas Ayurveda Medical College and Hospital Moodbidri
Dakshina Kannada District
Alvas Ayurveda Medical College and Hospital
vidyagiri Moodbidri
Dakshina Kannada District
Karnataka
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9964006795 |
| Fax |
|
| Email |
praveenbs76@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dharshana Krishnan O |
| Designation |
P G Scholar |
| Affiliation |
Alvas Ayurveda Medical College and Hospital |
| Address |
Department of P G studies in Panchakarma
Alvas Ayurveda Medical College and Hospital
Moodbidri
Dakshina Kannada District
Karnataka 574227
Alvas Ayurveda Medical College and Hospital
Vidyagiri Moodbidri
Dakshina Kannada District
Karnataka
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
8078471793 |
| Fax |
|
| Email |
dharshanakrishnano@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Panchakarma
Alvas Ayurveda Medical College and Hospital Moodbidri
Dakshina Kannada |
|
|
Primary Sponsor
|
| Name |
Dharshana krishnan O |
| Address |
Pratheeksha(ho)
Chirakkal (po)
Kannur
Kerala
670011
|
| Type of Sponsor |
Other [self] |
|
|
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 Dharshana Krishnan O |
Alvas Ayurveda Medical College and Hospital |
OPD and IPD of Department of Panchakarma
Alvas Ayurveda Medical
College and Hospital
Vidyagiri Moodbidri
Dakshina Kannada
KARNATAKA |
8078471793
dharshanakrishnano@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Clinical Ethics Committee Alvas Ayurveda Medical Collegell |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M179||Osteoarthritis of knee, unspecified. Ayurveda Condition: SANDHIGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Atasi Upanaha |
Purva Karma: Atasi choorna is made in to paste by adding Dhanyamla. Prepared semi solid paste is warmed and kept ready.
Pradhana Karma: Patient is asked to lie down in supine position or to sit comfortably with exposed knee joint. Then warmed paste is applied over the Janusandhi then it is covered with Eranda Patra and it is firmly bandaged with khora cloth.
Paschat Karma: Upanaha is retained for 12 hours and then removed and the part was cleaned with warm water. Upanaha is done for 7 days and the follow up is done on 15th, 30th,45th and 60th day after completion of treatment.
|
| Intervention |
Tila Upanaha |
Purva Karma:Tila Choorna made in to paste by adding Dhanyamla. Prepared Semisolid paste is warmed and kept ready.
Pradhana Karma: Patient is asked to lie down in supine position or to sit comfortably with exposed knee joint. Then warmed paste is applied over the Janusandhi then it is covered with Eranda Patra and it is firmly Bandaged with khora cloth.
Pradhana karma:Upanaha is retained for 12 hours and then removed and the part was cleaned with warm water. Upanaha is done for 7 days and the follow up is done on 15th, 30th, 45th and 60th day after completion of treatment. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patients having the signs and symptoms of Janu Sandhigatavata.
Patients between 30 to 75 years will be considered.
Patient who are fit for Upanaha Sveda |
|
| ExclusionCriteria |
| Details |
patients having Rheumatoid Arthritis, Gouty Arthritis.
Patient with acute traumatic injury to the knee.
Congenital bony deformity of knee joint. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Knee joint pain(Sandhi shoola)
Crepitus in knee joint(Sandhi Atopa)
Swelling in the knee joint (Sandhi Shotha)
Pain during flexion and extension of knee joint(Prasarana Akunchanayo) vedana |
60 days |
|
|
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, single blind clinical study comparing the efficacy of Tila Upanaha and Atasi Upanaha in patients suffering with sandhigata vata of knee joint.The trial is done daily for 7 days on 40 patients with Sandhigatavata selected through randomization technique from Alvas Ayurveda Medical College and Hospital Vidyagiri Moodbidri Dakshina Kannada India. Primary out come measures will be relief from knee joint pain, stiffness, swelling and tenderness.The patients will be followed up for a duration of 2 months. |