| CTRI Number |
CTRI/2022/11/047471 [Registered on: 21/11/2022] Trial Registered Prospectively |
| Last Modified On: |
19/11/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
ROLE OF JANUDHARA KARMA WITH TIL TAIL (SESAME OIL) IN THE MANAGEMENT OF JANU-SANDHIVATA (KNEE OSTEOARTHRITIS) |
|
Scientific Title of Study
|
A CLINICAL STUDY OF JANUDHARA KARMA WITH TIL TAIL (SESAME OIL) IN THE MANAGEMENT OF JANU-SANDHIVATA (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 GYAN PRAKASH SHARMA |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
Dr.SR Rajasthan Ayurved University Jodhpur |
| Address |
DSRRAU,UPGIASR, JODHPUR PG DEPARTMENT OF PANCHAKARMA Jodhpur RAJASTHAN 342017 India |
| Phone |
9829798701 |
| Fax |
|
| Email |
atreyagyan@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Brahmanand Sharma |
| Designation |
Associate Professor |
| Affiliation |
DSRRAU Jodhpur |
| Address |
PG Department of Kayachikitsa University Post Graduate Institute of Ayurved Studies and Research Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University
Karwar Nagaur Road Jodhpur Jodhpur RAJASTHAN 342037 India |
| Phone |
9460318138 |
| Fax |
|
| Email |
bkmudgal9@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
DR GYAN PRAKASH SHARMA |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
Dr.SR Rajasthan Ayurved University Jodhpur |
| Address |
DSRRAU,UPGIASR, JODHPUR PG DEPARTMENT OF PANCHAKARMA Jodhpur RAJASTHAN 342017 India |
| Phone |
9829798701 |
| Fax |
|
| Email |
atreyagyan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur |
|
|
Primary Sponsor
|
| Name |
Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur |
| Address |
Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Karwar Nagaur Road Jodhpur Pin 342037 |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Gyan Prakash Sharma |
Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University, University Hospital Of Ayurved |
Room no 11, Center of Excellence PG
Department of
Panchkarma, Dr
Sarvepalli
Radhakrishnan
Rajasthan
Ayurved
University,
Karwar Nagaur
Road Jodhpur
PIN-342037 Jodhpur RAJASTHAN |
9829798701 atreyagyan@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| dsrrau |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M170||Bilateral primary osteoarthritis of knee. Ayurveda Condition: SANDHIGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | tailadhArA, तैलधारा | (Procedure Reference: Ayurveda, Procedure details: 30 minutes per day) (1) Medicine Name: Tila Taila, Reference: Ayurveda, Route: Topical, Dosage Form: Taila, Dose: 1000(ml), Frequency: sos, Duration: 63 Days |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients Fulfilling The Diagnostic Criteria of Sandhigata-vata
2.Patients Age Group Between 40 to 70 Years of Both Male and Female Sex.
3. OA Grade 0 to 3 KL System (Kellgren And Lawrence System) |
|
| ExclusionCriteria |
| Details |
1.Patients With Secondary Arthritis , Rheumatoid Arthritis, Gouty Arthritis
2.Patients Having History of Joint Trauma and Other Systemic Illness |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
On the Basis of-
1.Knee joint X-ray will be taken before the start of process and after the completion of process.
2.Knee Injury and Osteoarthritis Outcome Score(KOOS)
3. VAS - Visual Analogue Score for Pain Assessment
|
90 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The result will be evaluated in the clinical parameter obtained before & after the completion of treatment. clinical Parameters-
1.Knee Joint X-Ray
2.Knee Injury and Osteoarthritis Outcome Score(KOOS)
3.Visual Analogue Score for Pain assessment(VAS) |
105 Days |
|
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/12/2022 |
| 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="2" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
Osteoarthritis
(OA) is a long-term chronic disease characterized by the deterioration of
cartilage in joints which results in bones rubbing together and creating
stiffness, pain, and impaired movement.Osteoarthritis (OA) is a chronic degenerative disorder of multifactorial
etiology characterized by the loss of articular cartilage, hypertrophy of bone
at the margins, subchondral sclerosis, and range of biochemical and
morphological alterations of the synovial membrane and joint capsule.In Ayurveda, the
disease Sandhivata resembles with osteoarthritis.In the present era,
modern medicines have gained wide acceptance and the knowledge regarding the
disease and treatment has ascended to its peak. A lack a satisfactory regimen is
not yet available in the field of health which can roll back the wear and tear of
joints. So in order to obtain a permanent and safest remedy this problem will
selected in the present study.This will help improve disease
monitoring and help facilitate the development of medicines that can reverse
the progression of this high-burden condition. Snehan and
swedan includingJanudhara both are local
therapeutic procedures.According to retention of time and temperature with
specific oil increase blood circulation of particular area then time of position
also help to reform cartilage and relax
supporting ligament and muscles.
|